Job description
Turn complex mechanical designs into proven, reliable implantable medical devices that patients can trust. In this role, you will join our Neuromodulation R&D team as a Staff Mechanical Verification Engineer, where you will play a critical role in verifying both sustaining and next-generation implantable products. You will own mechanical verification activities from test rationale through execution and reporting, working hands-on with implantable components in a highly collaborative, cross-functional environment. You will design and execute informal development tests and formal verification testing, create custom test fixtures, and develop scalable test infrastructure to support growing product needs. Partnering closely with principal-level mechanical engineers, you will help drive design improvements, validate solutions, and shape verification strategies for new products from the ground up. This role gives you the opportunity to combine deep technical rigor with real-world impact, ensuring that innovative neuromodulation therapies meet the highest standards of safety, reliability, and performance before reaching patients.
YOUR RESPONSIBILITIES
Define mechanical verification test rationale in collaboration with product design and clinical teams Execute informal development tests and formal verification tests Define and track detailed test plans Define, architect, design and drive implementation of scalable test infrastructure Define, design and qualify custom test fixtures for informal and formal testing Architect and own a dashboard of test execution completion, issues encountered and resolutions Own execution, interpretation and reporting of mechanical verification results Support FMEA, failure analysis, tolerance analysis, gauge R&R in close collaboration with process, manufacturing and design teams Architect and execute design of experiments (DoE) and associated technical reports Perform statistical analysis on datasets to summarize results and concisely communicate to a management audience Manage external vendors for test fixture development, outsourced test execution and data collection and review vendor test reports and ensure compliance with requirements Stay up-to-update with the regulatory trends and technologies in medical product development (e.g., effect of EU regulation changes) Virtually attend frequent meetings with worldwide teamRequired profile
REQUIRED QUALIFICATIONS
4+ years of mechanical design or verification in implantable medical device industry or similar high-reliability industry Bachelor's degree in Mechanical Engineering, BioMedical Engineering or equivalent Experience with definition of verification requirements Experience with mechanical verification and failure mode assessment Solid modeling software experience (e.g. SolidWorks) Experience executing tests on industry standard test equipment (e.g. Instron, thermal chambers, DAQs, etc.) Experience with rapid prototyping techniques (e.g., 3D printing, minor electrical assembly) Experience in the fabrication and rework of mechanical test fixture components using basic machine tools Basic knowledge of statistical analysis (particularly regarding Design of Experiments) and regression analysis (using JMP or similar) Experience working in cross-functional teams and consistently driving projects forward Strong written and oral communication skills for cross-functional and external communication Problem-solving and critical thinking, particularly in root cause investigation
PREFERRED QUALIFICATIONS
Candidates with one or more of the following qualifications will be prioritized
7+ years of mechanical verification in implantable medical device industry Master's degree in Mechanical Engineering, BioMedical Engineering or equivalent Experience working in an ISO 13485 regulated environment Familiarity with biocompatible materials and manufacturing processes in area of implantable leads, insertion needles, anchors and similar accessories, especially in spinal cord stimulators Experience managing electrochemical testing, including direct experience or oversight of consultants performing metal dissolution and biocorrosion studies (e.g. Cyclic Voltammetry - CV, Electrochemical Impedance Spectroscopy - EIS, and Potentiodynamic testing) Familiarity with project management methodologies and tools (e.g. MS Project, SmartSheet) Experience in use of AI for scripting and automation for managing large datasets Knowledge of Finite Element Analysis (FEA) using SolidWorks
TRAVEL REQUIREMENTS
Must be able to travel internationally and domestically, less than 10% of the time.
Company description
About Us
Micro Systems Engineering, Inc. (MSEI) is a pioneer in developing innovative implantable medical technologies that improve-and often save-the lives of millions living with cardiovascular conditions and chronic neurologic pain. With over 45 years of expertise in designing and manufacturing active implantable devices, our success is built on a foundation of core values: innovation, quality, reliability, integrity, teamwork, and deep technical excellence. These principles drive our global reputation for trust and confidence among physicians and patients alike. We're always seeking passionate engineers, scientists, technicians, and professionals to help advance our mission and shape the future of medical technology.
What we offer
You will design and execute informal development tests and formal verification testing, create custom test fixtures, and develop scalable test infrastructure to support growing product needs. Partnering closely with principal-level mechanical engineers, you will help drive design improvements, validate solutions, and shape verification strategies for new products from the ground up. This role gives you the opportunity to combine deep technical rigor with real-world impact, ensuring that innovative neuromodulation therapies meet the highest standards of safety, reliability, and performance before reaching patients.
Read LessJob description
As a Staff Mechanical Validation Engineer, you will play a critical role in ensuring the safety, reliability, and performance of implantable and external medical devices that directly impact patients' lives. As a senior technical contributor within the System Verification & Validation team, part of MSEI's broader R&D organization, you will lead mechanical system level verification and validation (V&V) efforts from strategy through test execution and documentation. You will combine deep mechanical engineering expertise with hands on test development, disciplined V&V planning, and cross functional leadership to support both current and next generation products. You will primarily support MSEI's Neuromodulation portfolio, where you will be accountable for developing and executing verification strategies for released products, cost reduction initiatives, and future product offerings in a highly regulated environment.
Your Responsibilities
Collaborate with cross functional teams to review mechanical designs and requirements.Develop comprehensive V&V test plans for new products and production improvements ensuring alignment with quality system requirements.Author test protocols for formal V&V tests to ensure consistency ahead of and during testing.Design, construct, and qualify mechanical and electrical bench test fixtures.Lead test method validation effort to demonstrate measurement and operator repeatability using statistical tools.Execute formal design verification testing using industry standard and custom-built test equipment.Author concise test reports clearly documenting the methods employed and results obtained.Work with regulatory department to author overall descriptions of test methods / results in support of FDA submissions.Create and maintain testing timelines for communication of status to management.Support FMEA, tolerance stack-up analysis, and failure analysis as bandwidth permits.Work with external vendors on outsourced projects to ensure any verification activities performed meet expectations of MSEI quality management system.Ensure compliance with FDA, EU MDR, and ISO standards.Required profile
Required Qualifications
Bachelor's degree in mechanical or biomedical engineering; MS preferred.7+ years experience in mechanical verification and validation (V&V) testing of medical or high reliability devices.Well rounded experience in mechanical / electrical fixture design, test development, and statistical analysis of results.Hands on experience with mechanical (i.e. tensile testers) and electrical (LCR, oscilloscope, etc.) test equipment.Experience in the fabrication and rework of mechanical test fixture components using 3D printing, milling, laser welding, saws, drills, etc.Knowledge of failure modes and effects analysis (FMEA) and application in product design.Must be a proficient CAD user (Solidworks preferred).Experience evaluating measurement systems through Gage R&R, bias, linearity, stability, and other MSA methods.Demonstrated ability to lead cross functional projects.Exceptional technical documentation skills; produces clear, accurate, and audit-ready documentation.
Preferred Qualifications
10+ years of experience in verification of implantable medical devices.Experience in the design and testing of neuromodulation implantable components.Hands on experience with automated test fixture development, including programming (C# preferred).Knowledge of project management tools and methodologies.Experience applying formal risk management principles throughout the product lifecycle.
Physical Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile.The employee is also required to interact with a computer for extended periods of time and communicate with co-workersCompany description
About Us
Micro Systems Engineering, Inc. (MSEI) is a pioneer in developing innovative implantable medical technologies that improve-and often save-the lives of millions living with cardiovascular conditions and chronic neurologic pain. With over 45 years of expertise in designing and manufacturing active implantable devices, our success is built on a foundation of core values: innovation, quality, reliability, integrity, teamwork, and deep technical excellence. These principles drive our global reputation for trust and confidence among physicians and patients alike. We're always seeking passionate engineers, scientists, technicians, and professionals to help advance our mission and shape the future of medical technology.
What we offer
As a senior technical contributor within the System Verification & Validation team, part of MSEI's broader R&D organization, you will lead mechanical system level verification and validation (V&V) efforts from strategy through test execution and documentation. You will combine deep mechanical engineering expertise with hands on test development, disciplined V&V planning, and cross functional leadership to support both current and next generation products.
Read LessJob description
PRIMARY RESPONSIBILITIES:
Perform visual inspection on incoming components using automated inspection equipment and a variety of microscopes.Prioritization of incoming tasks and disposition of incoming material according to the requirements of the material management system (SAP).Setup inspection and handling equipment to meet the requirements for specific incoming inspection tasks. This includes programming of component test equipment.Setup, operate, and perform routine maintenance on automated equipment, tools, and systems.Responsible for status monitoring and first-level troubleshooting, equipment recoveries and repairs that are commensurate with applicant's level of expertise, training, and latitude provided by various Engineering groups.Follow released work instructions and receive verbal or written instructions regarding duties to be performed, including special requests with limited documentation.Performs quality charting, analyzing, interpreting data tracking, and running reports through our automated systems for continuous improvement and tracking of factory deliverables.Escalate nonconforming processes, components, designs to product specification and any procedures that cannot be performed as documented.Documentation of process changes when the need arises, due to any factors that may influence those processes.Other duties may be assigned at the discretion of the manager.Required profile
EDUCATION / EXPERIENCE REQUIREMENTS:
Associate degree or high school diploma with equivalent work experience in related fieldExperience in SMT assembly, component packaging, or wafer processingVerbal and written communication skillsMS Office and general computer proficiencyAbility to use a microscopeAbility to work independently with minimal directionCritical thinking skillsDetail oriented
ADDITIONAL PREFERRED KNOWLEDGE, SKILLS, ABILITIES:
Experience with SAPExperience operating automated equipmentExperience in electronics manufacturing
PHYSICAL REQUIREMENTS:
The physical demands described within this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobileThe employee is also required to interact with a computer for extended periods of time and communicate with co-workersThe employee is required to use a microscopeMust be able to work a minimum of 40 hours / weekCompany description
About Us
Micro Systems Engineering, Inc. (MSEI) is a pioneer in developing innovative implantable medical technologies that improve-and often save-the lives of millions living with cardiovascular conditions and chronic neurologic pain. With over 45 years of expertise in designing and manufacturing active implantable devices, our success is built on a foundation of core values: innovation, quality, reliability, integrity, teamwork, and deep technical excellence. These principles drive our global reputation for trust and confidence among physicians and patients alike. We're always seeking passionate engineers, scientists, technicians, and professionals to help advance our mission and shape the future of medical technology.
Join our Manufacturing team as a QARI (Quality Assurance, Receiving, Inspection) Specialist.
In this critical role, you'll be responsible for ensuring the integrity of incoming components through precise electrical testing, detailed visual inspections, and adherence to established quality protocols. You'll set up and operate inspection equipment, verify product specifications, and manage the complete testing cycle-from evaluation and documentation to final disposition or shipment.
What we offer
With over 45 years of expertise in designing and manufacturing active implantable devices, our success is built on a foundation of core values: innovation, quality, reliability, integrity, teamwork, and deep technical excellence. These principles drive our global reputation for trust and confidence among physicians and patients alike.
Read LessJob description
In this role, you will provide technical leadership and hands on contributions across all phases of product development, from early market and clinical definition through design, release, and long term maintenance. You will bring broad, cross disciplinary expertise beyond IC design, working closely with research, manufacturing, quality, testing, and clinical teams to deliver highly reliable silicon that meets stringent medical and regulatory requirements.
Your success will be measured by the on time delivery of product specific integrated circuits that address key clinical and business needs while exceeding industry standards for performance, reliability, and quality. Using state of the art CAD and simulation tools, you will design, integrate, and verify complex circuits and systems, influencing architecture decisions and critical design tradeoffs.
You will collaborate directly with system hardware, software, and clinical engineering teams, medical consultants, and IC design, test, and layout engineers across U.S. and international design centers, playing a pivotal role in bringing advanced implantable technologies from concept to production.
PRIMARY RESPONSIBILITIES
Design and development of high-performance and high-reliability ultra-low power analog but also mixed signal integrated circuits for implantable medical products.Active involvement in all aspects of IC design, including the development of functional concepts and specifications, top-level design architecture, design partitioning and block level design, detailed circuit design and simulation, layout floor-planning and transistor level layout, bench verification and testing, test-vector development, and documentation.Design of novel, robust, ultra-low power, low-voltage analog/mixed-signal IC functional blocks including but not limited to voltage/current references, operational amplifiers, comparators, switched-capacitor circuits (amplifiers, filters, charge pumps, etc.), ADCs and DACs, oscillators, switching power circuits, communication circuits, etc.Design of ultra-low power digital functional blocks (combinatorial, sequential, synchronous, asynchronous, state machines, etc.) for timing, control, interfacing and signal processing.Create behavioral models for modules and system level verification models for circuits. Perform pre-silicon verification and post-silicon validation of circuits. Collaborate with IC Test group to define production vectors.Consult with physicians, clinical research, published literature, and technology leaders on new and existing technologies, trends, and requirements for their uses.Required profile
Advanced degree in Electrical Engineering (MS / PhD) with additional background in business principles with demonstrated expertise in fundamental electrical engineering, circuit, and systems principles and closed form analytical approaches. The candidate should be a self-motivated independent thinker able to apply industry research and personal experience to design proposals combined with strong verbal communications skill and strong technical document writing skills.8+ years of experience in analog/mixed-signal IC design for very low power portable and/or implantable applications, with a strong grasp of the tradeoffs involved in using various analog and digital circuit design techniques (RTL or schematic based) to optimally implement system functions. Preferred: 5+ years implantable medical device industry experience including FDA regulated design controls and product approval process.Deep understanding of CMOS processes, device characteristics and models, transistor level circuit analysis and design concepts and trade-offs: BW, noise, power, feedback analysis, stability etc., worst case process corners, margin and Monte Carlo analysis, and design-for-test. Knowledge of low power flows, including voltage/power domains, power shutoff, retention is desiredSolid understanding of circuit building blocks (op-amps, comparators, voltage and current references, DACs, ADCs,) and layout techniques for ultra-low power design to deliver robust, production quality silicon designs. Preferred: Experience with medical domain specific designs such as neuromodulation, charging, low noise biomedical signal measurement and processing, battery energy conversion techniques, and very low power RF communication circuits.Extensive working knowledge and use of Cadence mixed signal Design tools, Virtuoso XL, Spectre, Xcelium/AMS simulators along with Maestro, and other mixed signal signoff tools for analog regression testing. Preferred: Knowledge of scripting/language (perl, shell, tcl, python) along with C/C++, as well Matlab is desirableExperience in lab bench characterization and test-vector generation for pre-silicon and post-silicon verification, design-for-manufacturing test vector generation, production support, fault isolation and failure analysis, and pre-clinical and clinica testing environments.The candidate would demonstrate industry recognition of technical accomplishments in the form of patents and/or published articles. Preferred: Experience with international teams and a working knowledge of German would be highly desirable.
PHYSICAL AND TRAVEL REQUIREMENTS
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile.The employee is also required to interact with a computer for extended periods of time and communicate with co-workers.Must be able to travel to other office locations.Must be able to travel internationally and domestically, less than 5% of the time.Company description
About Us
Micro Systems Engineering, Inc. (MSEI) is a pioneer in developing innovative implantable medical technologies that improve-and often save-the lives of millions living with cardiovascular conditions and chronic neurologic pain. With over 45 years of expertise in designing and manufacturing active implantable devices, our success is built on a foundation of core values: innovation, quality, reliability, integrity, teamwork, and deep technical excellence. These principles drive our global reputation for trust and confidence among physicians and patients alike. We're always seeking passionate engineers, scientists, technicians, and professionals to help advance our mission and shape the future of medical technology.
Our elite PDX IC Design group is looking for a Principal Analog IC Design Engineer to lead and personally contribute to the innovation, design, and development of ultra low power analog and mixed signal integrated circuits used in life critical implantable medical devices.
What we offer
With over 45 years of expertise in designing and manufacturing active implantable devices, our success is built on a foundation of core values: innovation, quality, reliability, integrity, teamwork, and deep technical excellence. These principles drive our global reputation for trust and confidence among physicians and patients alike.
Read Less