Job Title:
Director, IT Infrastructure
Reporting to:
CFO
Location:
San Jose, California
Job Site:
On-Site
Job Description Revision Date:
May 26, 2026
About us:
Gener8 is a US based Company, headquartered in Silicon Valley. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 is a growing company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Costa Rica.
The Director of IT Infrastructure is a hands-on role for a multisite, engineering services, product design, and manufacturing organization. You will be expected to provide thought leadership, business acumen, as well as hands-on support to an engineering (hardware and software) focused user community. You will have overall responsibility for the Company’s IT Infrastructure across multiple locations. You will also have responsibility for cybersecurity for the Company.
Responsibilities:
“Owner” of Company’s IT Infrastructure with a focus on secure, scalable and cost-effective solutions.Leadership and management of a small IT Infrastructure and Help Desk team (2-3 people) including hiring, training, mentoring, supervising, etc. Support for company-wide applications, Infrastructure and services. Including but not limited to Active Directory, Google Workspace, SolidWorks, Okta, Zoom, CrowdStrike, Arena PLM, QAD,AD, fileserver/storage, firewalls & switches, etc.Virtualization environments include Hyper-V and VMware environments across multiple locations, including sever hardware, storage, configuration, licensing, monitoring, capacity, & performance management.Oversee and manage production systems including backups, performance tuning, fault resolution, capacity planning, & root cause analysis across multiple sites, platforms & operating systems.Improve the efficiency, ease of management, & performance of the existing infrastructure through discovery, evaluation & testing, and comparing against industry best practices.Effectively manage time & priorities. Deliver projects on schedule & communicate issues with teammates proactively.Occasionally handle tier-2-3 escalated Help Desk tickets.Qualifications:
BS degree in Computer Science, Business, Engineering or equivalent experience requiredAdvanced degree highly desirable10+ years experience in an engineering services and product development company10+ years experience supporting a high-tech manufacturing firm including all shop floor applications and hardware10+ years at a Sr. Manager or higher level10+ years experience supporting Google Workspace across multiple locations for high tech companies10+ years’ experience supporting custom software development and associated tools10+ years of relevant industry experience supporting multiple locations, heterogeneous environments (Windows, Linux, iOS,), etc.10+ years’ experience and demonstrated expert level knowledge of Active Directory including management of, consolidating domains, etc.5+ years’ experience and demonstrated expert level knowledge of VMware 5+ years experience managing Okta for SSO and MFA 5+ years’ experience supporting Arena PLM5+ years experience managing vendor negotiations and renewals5+ years’ experience managing and supporting Azure, with a focus on moving workloads from on premises to the CloudPrior experience leading an Infrastructure team in a SOX regulated companyPrior experience supporting an Engineering services organization leveraging SolidWorks across multiple sites Prior experience managing Proofpoint or similar solution highly desirablePrior experience with Palo Alto Networks (firewalls, Panorama, Global Protect) highly desirablePrior experience with Meraki (, wireless) highly desirablePrior experience with Cisco switches highly desirablePrior experience with Veeam highly desirablePrior experience in a PE backed portfolio company highly desirableUnderstanding of what “good looks like” at a larger corporation, with startup “can do” mentalityStrong interpersonal & communications skills. The person in this position must be able to integrate & communicate clearly & easily with other team members, as well as with end-users at all levels.
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
Read LessJob Title:
Sr. Technical Project Manager
Reporting to:
VP, PMO
Location:
Carlsbad, CA
Job Site:
On-Site
Job Description Revision Date:
June 2026
About us:
We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 is a growing company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica.
Summary:
We are seeking an experienced and dynamic Sr. Technical Project Manager to lead and coordinate projects within our consumables business line at our Carlsbad, CA facility, with occasional cross-site projects involving instrument hardware. The ideal candidate will possess strong leadership skills, technical knowledge of product development, and a proven track record in managing cross-functional teams.
In this role you will be responsible for timely project delivery, profit & loss accountability, and customer satisfaction through the management of project related activities and resources. You must be an excellent leader and possess experience in managing staff of different disciplines to produce results in a timely manner. You must be able to develop efficient strategies and tactics to manage projects and handle client requests. Experience with FDA regulatory compliance and design quality is a plus, particularly for cross-site projects involving instrument hardware.
Essential Duties and Responsibilities:
Manage one or several concurrent contracts and budgets with annual revenues up to $2-5M ensuring financial accountability and profitability.Oversee the execution of contracts, ensuring compliance with applicable regulatory standards (e.g., FDA, ISO 13485, where required) and client-specific requirements.Participate, as needed, in the execution of documents and assessments such as dFMEA, pFMEA, Risk Management Plan, Hazard ID, Design Input Requirements, Design & Development Plan, and the DHF.Lead a cross functional team and a complex design through the NPI design transfer process from development to production.Provide technical expertise to understand project-critical functions, specifications, and risks, delivering concise updates and solutions to clients.Collaborate closely with clients to understand their needs and preferences, ensuring project deliverables meet or exceed expectations.Ensure the highest standards of customer service and client satisfaction throughout all stages of the project lifecycle.Collaborate with project managers and stakeholders at other sites on cross-site projects involving instrument hardware, ensuring alignment with project objectives.Step in to own project management tasks when resource gaps occur, maintaining continuity of project execution.Create, maintain, and manage detailed project schedules, ensuring all tasks and milestones are tracked and completed on time.Continuously improve project management processes, recommending and implementing best practices for operational efficiency.Conduct thorough technical and project document reviews, ensuring compliance with applicable regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, where required) and company protocols.Gather data for invoicing, budgeting, and project reporting to keep stakeholders informed on progress and financial status.Proactively identify and escalate issues, risks, or delays to senior management, providing recommendations for resolution.Collaborate with cross-functional teams (e.g., R&D, Engineering, Manufacturing) to develop comprehensive project budgets and accurate quotes.Track, evaluate, and report on project metrics, identifying areas for improvement and optimizing performance.Engage regularly with stakeholders to provide status updates, align project goals, and address any evolving requirements or challenges.
Supervisory Responsibility:
This position has no direct supervisory responsibility.
Qualification Requirements:
Bachelor’s degree in Engineering or a related field is required.PMP strongly preferred. Candidates with a PMP certification will be given priority.5+ years of project management experience in healthcare, life sciences, or biotech industries, with experience in consumables and/or instrument product development.Experience with consumables product development is required; instrument hardware development experience is a plus, particularly for cross-site projects. Experience working in FDA-regulated environments and familiarity with ISO 13485 and/or 21 CFR 820 is preferred.Working knowledge of project/program management software (e.g., Smartsheet, Power BI, MS Project) is a plus.Proven ability to manage cross-site, multi-disciplinary teams, ensuring project success.Strong leadership and organizational skills, with the ability to mentor and motivate teams.Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.Exceptional interpersonal and communication skills (both oral and written), with experience in client-facing roles.Strong problem-solving and conflict resolution skills, with the ability to manage risk and navigate challenges effectively.Expertise in project/program management methodologies, tools, and techniques.
Working Conditions:
Position requires gowning procedures for a controlled environment. Typically works around high-speed machinery, hydraulics, electric, and pneumatics requiring Lockout Tag Out Procedure to be followed and close attention given to safety. May require the use of eye protection, as needed, and hearing protection when working in high noise level area. Additional PPE may be required, i.e. gloves, face masks, face shields, depending on the specific job being performed and company safety rules and regulations.
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
Read LessJob Title:
NPI (New Product Introduction) Engineer
Reporting to:
Carlsbad NPI Leader
Location:
San Jose, CA
Job Site:
On-Site
Job Description Revision Date:
May 2026
About us:
We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 is a growing company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica.
Job Duties:
As an integral member of the transfer team, operating under the guidance of the Project Manager, the New Product Introduction (NPI) Engineer plays a crucial role in facilitating the transition of designs into manufacturing. In close collaboration with Research and Development, Manufacturing Engineering, and Operations teams, the NPI Engineer’s key responsibilities include:
• Seamless setup of components, Bills of Material (BOMs), work instructions, and procedures, including tooling and fixtures.
• Ensure the timely transition of designs into manufacturing, actively supporting steady-state production.
• Conduct and lead Design for Excellence (DFx) projects, optimizing cycle time, material cost, and serviceability.
• Complete technical and transfer deliverables within established timelines and budget constraints.
• Provide technical guidance on all aspects of short-run beta and pilot builds, including material management, documentation, resource development, and delivery.
• Develop relationships with suppliers to resolve issues with single sources, high cost or lead time, and poor quality.
• Design parts and modify documentation utilizing SolidWorks design tools and Product Data Management (PDM) systems.
• Utilize Jira or Smartsheet in a large-scale project environment for effective communication, status updates, and milestone tracking.
• Regularly communicate technical status to customers and Gener8 stakeholders.
• Lead the creation, development, and implementation of test fixtures and equipment for complex electro-mechanical, fluidic, and optical subsystems.
• Execute internal processes following Gener8's Quality Management System (QMS), including Engineering Change Orders (ECO), Non-Conformance Reports (NCR), Return Material Authorizations (RMA), Deviation, and Corrective and Preventive Action (CAPA) processes.
• Apply problem-solving tools and lead Root Cause Analysis (RCA) activities with cross-functional teams.
• Design and set up production lines, ensuring balance and efficiency using tools such as Value Stream Mapping (VSM) and process flow charts.
Requirements:
• Three years of experience in design, structure, and engineering analysis using SolidWorks or similar tools.
• Two years of experience working on large-scale multimillion-dollar projects, interfacing with Scientists, Development, Quality, and Manufacturing.
• Two years of experience in direct face-to-face communication, acting as a key technical customer contact for new products being launched into production.
• Two years of experience developing fixtures across different platforms, including optics, electronics, and mechanical.
• Must have completed at least 3 Value Analysis/Value Engineering or Kaizen projects optimizing cycle time, material cost, or serviceability.
• Two years of experience employing Jira or equivalent Kanban board system on a large-scale project to manage communication and priorities.
• Two years of experience developing large-scale supply base, improving relationships and performance metrics such as cost, delivery, and quality.
• Experience must include efficiency improvements in three production lines achieved by collecting and analyzing applicable data to improve cycle time.
• Three years of experience in setting up and structuring complex instrument Bills of Material (BoMs), exceeding 1,000 line items in Arena or similar PDM.
• Technical responsibility for at least one beta or pilot unit build process of complex instruments from start to finish.
Why Join Us?
We operate at the intersection of "cool science" and "precision engineering." You will be the guide of a company that builds the tools that save lives.
Our Culture: We value high autonomy, intellectual rigor, and a healthy dose of wit. We work hard because the software we build matters.
Message to applicants:
The salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. locations, not including benefits. For non-sales roles the hiring ranges reflect base salary only. Individual pay is determined by the candidate's hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. hiring location.
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
Read LessJob Title:
Planner
Reporting to:
Director, Global Purchasing and Logistics
Location:
San Jose, California
Job Site:
On-Site
Job Description Revision Date:
June 2026
About us:
We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 has offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica.
We are looking for a Planner to create track and report work orders. Present product updates and recommended actions to Executive management team on a weekly basis. Plan, track, and control raw material inventories in order to ensure production schedules can be met, raw material inventories are accurate and raw material inventories are maintained within defined limits. The Planner is responsible for setting and changing daily production schedules that maximize output of established priorities. Approve ECO implemented stage, editing all open work order control rework parts based on ECO Information and inform action to provide update information to vendor.
Duties and Responsibilities:
Procures all raw materials, electrical components for PCBA, analyze inventory consumption and set Min/Max points according to balancing availability and cost of inventory.Negotiates with vendor and Contract manufacture for quote in pricing and lead time. Works with suppliers on order status, quality, terms of delivery, and contract provisions.Expedites to ensure adherence to inventory guidelines.Performs vendor analyses comparison to determine which vendor is aware of business plans the purchase of raw materials on PCBA’s and other electronic components based upon inventory stock schedules along with information obtained from company sales and production forecasts.Has daily MRP (Material Review Planner) reviews, assists in the scheduling and planning of purchases of PCBA assemblies.Builds and release orders and reports information to Operations/Program Management.Provides regular status updates of material availability and shortages as required to meet production schedules.Ensures consistency between customer demand information and production build schedules.Performs material and capacity analysis; Work with Scheduler to establish a production schedule for each order and communicate/resolve issues related to discrepancies between the requested and promised due date.Analyzes potential impact of forecast and production schedule changes on component procurement and production volume.Manages open Purchase Orders and Work Orders to ensure proper closure.Resolves issues, invoice discrepancies and coordinate rework and return as needed.Develops schedules in accordance with operational schedules, manpower capabilities and physical resources of Manufacturing Engineering, Production Test and Support, Assembly, Test Engineering and Material Services.Ensures that Supplier builds forecasts are correct and delivered on time Review and process ECO, RWK and NCR on implemented stage, audit work order to meet the required changes.Maintains a 4 to 6 week Planned Work Backlog maximum, field investigate work orders as necessary.Provides material management support for projects.Coordinates all aspects of the supply chain escalation.Sets up ASL (Approved Supplier List) and follows up regarding all Return Merchandise Authorization and rework in timely manner.Plans and maintains inventory levels of current stock to ensure adequate supply chain for each design phase to meet schedule board build forecast without shortages.Education:
BS Degree is Finance, Business or related discipline. 2 years experience.
Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status.We are an Everify Employer. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration.
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
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Job Title:
Director of Market Development
Reporting to:
Founder
Location:
San Jose, CA, hybrid or remote
Job Site:
Hybrid
Job Description Revision Date:
February 20, 2026
About us:
Gener8 is an innovative tech company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica. We know what it takes to be a key partner in the life science and medical device industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering and software design services and manufacturing complex instruments and consumables. Our customers are striving for breakthroughs in medical research and diagnostic applications as well as surgical devices that help scientists and medical professionals understand and diagnose diseases and improve patient treatment outcomes.
We are seeking a results-driven individual to join our growing organization as Director of Market Development with primary responsibility to grow our instrument engineering business based in San Jose, CA and Wilmington, MA. We are looking for a rare breed of professional: a highly technical engineer who is equally energized by interacting with customers to cultivate a mutually beneficial business relationship. You won’t just be selling services; you will be architecting the future of life science and diagnostic technologies. You will work with founders and R&D heads at some of the world’s most innovative biotech companies to transform their biological breakthroughs into robust, manufacturable products.
Duties and Responsibilities:
New Customer Focus: Develop and execute the overall business strategy for growth of our instrument engineering business that acquires new customers and brings diversity in application, customer size, and funding sourceBusiness Development: Find and cultivate high-value partnerships within the life sciences, genomics, and diagnostics sectors as well as other industries where our technical strengths are relevant. You will spend much of your time where potential customers can be found – industry trade shows, academic presentations, startup incubators, and engineering social eventsCommercial Leadership: Manage and drive the prospecting, proposal scoping and writing, and other commercial activities necessary to meet revenue targets Relationship Management: Serve as a trusted advisor to clients, understanding their business and technical objectives and translating their scientific requirements into engineering specifications. You will be comfortable discussing highly technical concepts with CEOs, CTOs, and VPs of R&D.Requirements and Qualifications:
Master’s or PhD in Mechanical, Electrical, Biomedical Engineering, or a related field. An MBA is a plus.10+ years in engineering design, with at least 4 years in a client-facing business development or "Sales Engineer" capacity.Proven track record in the life sciences/diagnostics space.Comfortable and effective at influencing across organizational boundaries without formal authority.Why Join Us?
We operate at the intersection of "cool science" and "precision engineering." This isn't a role where you'll be stuck behind a CAD station all day, nor is it a cold-calling sales job. You will be the technical face of a company that builds the tools that save lives.
Our Culture: We value high autonomy, intellectual rigor, and a healthy dose of wit. We work hard because the instruments we build matter.
Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status.We are an Everify Employer. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration.
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
Read LessJob Title:
Director, Market Development (Software)
Reporting to:
VPGM of Software
Location:
San Diego (West) or Boston (East)
Job Site:
Hybrid
Job Description Revision Date:
February 26, 2026
About us:
Since 1997, The RND Group has been a leader in FDA-regulated software development, offering full SDLC delivery for critical FDA submissions. Now a part of Gener8—a premier engineering and manufacturing partner with a global footprint—we help life science and medical device innovators turn complex concepts into market-ready realities.
We are looking for a Manager of Market Development to scale our software engineering business in Indianapolis. This is a unique role for a technical expert who thrives on building high-impact client relationships. You won’t just sell services; you will act as a strategic architect, collaborating with biotech founders and R&D leaders to transform scientific breakthroughs into life-saving medical technologies.
Duties and Responsibilities
Strategic Growth & Market Expansion: Architect and execute a comprehensive business strategy to scale our software engineering division. Your goal is to diversify our portfolio by securing new partnerships across various applications, company scales, and funding stages.High-Impact Business Development: Identify and cultivate elite partnerships within life sciences, genomics, and diagnostics. You will be the face of the organization where innovation happens—engaging with industry leaders at trade shows, academic symposiums, startup incubators, and high-level networking events.Commercial Pipeline Leadership: Take full ownership of the commercial lifecycle. This includes aggressive prospecting, strategic proposal scoping, and technical writing to ensure software revenue targets are consistently met or exceeded.Strategic Relationship Management: Act as a high-level advisor to client leadership. You must be adept at translating complex software regulatory requirements and technical architectures into strategic value for CEOs, CTOs, and VPs of R&D, ensuring their long-term business and technical objectives are realized.Requirements and Qualifications:
Technical Degree: BS or MS in Computer Engineering, Computer Science, or a related field. An MBA is a plus.Industry Tenure: 10+ years in software engineering, with at least 4 years in client-facing business development or "Sales Engineer" capacity.Regulatory Exposure: Deep familiarity with FDA regulations (specifically 21 CFR Part 820), ISO 13485, and IEC 62304 (the standard for medical device software lifecycle).Sales/BD Track Record: Proven track record in the consultative life sciences/diagnostics space.High Emotional Intelligence (EQ): Exceptional relationship-building skills to cultivate "mutually beneficial" long-term partnerships, not just one-off salesTravel: Willingness to travel (typically 25–40%) to visit clients, attend trade shows, and visit the other Gener8 offices.
Why Join Us?
We operate at the intersection of "cool science" and "precision engineering." You will be the guide of a company that builds the tools that save lives.
Our Culture: We value high autonomy, intellectual rigor, and a healthy dose of wit. We work hard because the software we build matters.
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program Read LessJob Title:
Sr. NPI Technician
Reporting to:
NPI Supervisor
Location:
San Jose, CA
Job Site:
On-Site
Job Description Revision Date:
March 2025
About us:
Since 2002, Gener8 has been a strategic partner in the life sciences and medical device industries, turning innovative concepts into market-ready realities. We provide comprehensive engineering design and manufacturing services for complex instruments, software, and consumables. Our team supports global innovators striving for breakthroughs in research, diagnostics, and surgical technology. With a specialized footprint spanning San Jose and Carlsbad, CA; Wilmington, MA; Indianapolis, IN; and San Jose, Costa Rica, Gener8 is uniquely positioned to deliver the precision and scale required by today’s medical professionals.
Sr. NPI Technician will be part of a diverse and multi-functional team working on high-end engineering projects that are transferring into production. You will be tasked with working through challenging pre-production builds and documenting findings. You will be expected to focus on critical project deliverables expected from the project manager, lead engineer, or direct lead. As part of the team your efforts will be combined to improve processes, implement best practices, and continually improve capabilities.
High-School Degree. AS Degree prefferred, BS Degree a plus (Technical Field)
Experience: 5+ years of experience, with at least 3 years in a regulated manufacturing environment (Life Sciences).Experience in reading drawings, layouts, schematicsAbility to thrive in a fast-paced ever-changing environmentPrototype development experience, cable assembly, electromechanical assembly, chassis/box building, intuitive process developmentUnderstanding and experience in testing electromechanical equipment and subassembliesAdept in using Microsoft Word, Excel, PowerPointCAD skills in solid modeling or other design tools are preferredTrained in the setup and use of oscilloscopes, frequency generators, power supplies and other basic lab equipmentTrained in the use of measurement tools such as micrometers, comparators, CMM, visual inspection equipmentLean Manufacturing Experience preferred Read LessJob Title:
Regional Facilities Manager
Reporting to:
Global Vice President, Operations
Location:
San Jose, CA
Job Site:
On-Site
Job Description Revision Date:
March 2025
About us:
Since 2002, Gener8 has been a strategic partner in the life sciences and medical device industries, turning innovative concepts into market-ready realities. We provide comprehensive engineering design and manufacturing services for complex instruments, software, and consumables. Our team supports global innovators striving for breakthroughs in research, diagnostics, and surgical technology. With a specialized footprint spanning San Jose and Carlsbad, CA; Wilmington, MA; Indianapolis, IN; and San Jose, Costa Rica, Gener8 is uniquely positioned to deliver the precision and scale required by today’s medical professionals.
Summary:
The Regional Facilities Manager will oversee the operational maintenance, safety, and regulatory compliance of multiple manufacturing and engineering sites within the US. This role ensures that all physical infrastructure supports high-precision manufacturing, focusing on cleanroom integrity, environmental monitoring, and business continuity. You will provide a world-class environment for production, engineering, and administration. Minimal travel will be required.
Key Responsibilities:
Regulatory Compliance & Environment:Maintain facilities in strict accordance with ISO 13485 and FDA standards.Oversee the certification and maintenance of Cleanrooms (ISO Class 7/8), ensuring HEPA filtration and pressure differentials meet validated specifications.
Required Qualifications:
Why Join Us?
We operate at the intersection of "cool science" and "precision engineering." You will be the guide of a company that builds the tools that save lives.
Our Culture: We value high autonomy, intellectual rigor, and a healthy dose of wit. We work hard because the software we build matters.
Message to applicants:
The salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. locations, not including benefits. For non-sales roles the hiring ranges reflect base salary only. Individual pay is determined by the candidate's hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. hiring location.
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
Job Title:
Director, NPI
Reporting to:
Vice President, Global Operations
Location:
San Jose, California
Job Site:
On-Site
Job Description Revision Date:
November 25, 2025
About us:
We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 has offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica.
The Director of NPI Engineering leads the cross-functional introduction of new products from concept through production launch. This role is responsible for building scalable NPI processes, driving manufacturing readiness, validating design for manufacturability (DFM), and ensuring that new products meet quality, cost, and schedule targets. The Director oversees NPI program managers and manufacturing/industrial engineers and works closely with R&D, Product Management, Supply Chain, Quality, and Operations.
Duties and Responsibilities:
Strategic Leadership
Develop and execute the NPI strategy, aligning engineering, operations, and business goals.Establish and refine NPI processes and phase-gate methodologies (e.g., PDP and PLM workflows).Define organizational structure, resource plans, and skill development to support growth.Program Execution & Cross-Functional Leadership
Lead cross-functional teams through the full NPI lifecycle: concept validation, prototyping, EVT/DVT/PVT, pilot builds, ramp-up, and full production.Own project timelines, budgets, risk management, and executive reporting.Ensure design intent, manufacturability, reliability, and compliance requirements are translated into production-capable solutions.DFM/DFA and Manufacturing Readiness
Drive DFM, DFA, and DFT reviews with design engineering teams.Oversee the development of process flows, PFMEAs, work instructions, and production tooling requirements.Ensure manufacturing lines, equipment, and test systems are ready for pilot and volume builds.Supplier & Supply Chain Integration
Collaborate with Supply Chain and suppliers to ensure component readiness, process capability, and manufacturability.Support vendor selection, qualification, and development for new technologies and components.Quality & Compliance
Partner with Quality to define validation plans, reliability testing, and regulatory documentation.Ensure pilot builds meet quality standards, yield targets, and product performance requirements.Continuous Improvement
Identify opportunities to improve cost, time-to-market, and product robustness.Champion Lean, Six Sigma, and operational excellence initiatives within the NPI organization.Required Education:
Bachelor’s degree in mechanical, Electrical, Manufacturing Engineering, or related field; master’s degree preferred.10+ years of experience in product development or manufacturing engineering, including 5+ years in NPI leadership roles.Proven success launching complex hardware or electro-mechanical products into production.Deep understanding of DFM principles, manufacturing processes, reliability engineering, and quality systems.Strong program management skills with experience managing multi-disciplinary teams.Excellent communication skills, including executive-level reporting and stakeholder management.
Required Experience:
10+ years of experience in product development or manufacturing engineering, including 5+ years in NPI leadership roles.Proven success launching complex hardware or electro-mechanical products into production.Deep understanding of DFM principles, manufacturing processes, reliability engineering, and quality systems.Strong program management skills with experience managing multi-disciplinary teams.Excellent communication skills, including executive-level reporting and stakeholder management.Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status.We are an Everify Employer. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration.
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
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