As the Sr. Manufacturing Engineer on the New Product Introduction (NPI) team at Riverpoint Medical, you will be at the forefront of bringing innovative medical, dental, and veterinary devices from concept to full-scale production. Your primary mission will be to lead the successful transfer of new products and processes into manufacturing, ensuring robust, efficient, and compliant operations that support our growth and quality objectives.
Duties and Responsibilities for the position include:
Lead end-to-end manufacturing process development and production transfer for new products.Drive DFM/DFA strategy and provide early manufacturing input during design and development.Own NPI manufacturing deliverables including process flows, work instructions, tooling, and equipment. Create and define new manufacturing processes and assembly methods for complex or novel products.Develop and author technically rigorous production work instructions, process documentation, and visual aids that translate design intent into repeatable, compliant manufacturing execution.Define and lead operator training strategy for new products, including development of training materials, hands‑on training support, and verification of operator readiness during pilot builds and production ramp.Plan and execute process validations (IQ/OQ/PQ) in compliance with FDA, ISO 13485, and internal quality systems.Act as a manufacturing subject matter expert for NPI programs and influence cross-functional decisions.Mentor other Manufacturing Engineer team members. Balance quality, cost, delivery, and risk in manufacturing decisions.Align technical solutions with overall business strategy and priorities.Education and Qualifications
Bachelor’s or Master’s degree in Engineering (Manufacturing, Mechanical, Chemical, or Industrial preferred).7-10 years’ experience in process or manufacturing engineering, with a strong track record in NPI and process transfer within a regulated manufacturing environment.Demonstrated expertise in process validation, Lean/Six Sigma, and project management.Experience leading cross-functional teams through product launches and process scale-up.Strong analytical, problem-solving, and communication skills.Experience in Medical Device (5+ years) or highly regulated environment Experience with new product introduction (1-3+ years) is highly desirableExperience with statistical analysis of data (Ex. Minitab, JMP, etc.)We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays. We also reward our team with bonus pay such as Referral Bonus and Annual Bonus!
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status
Read LessRiverpoint Medical in Northeast Portland is hiring a Development Engineer II. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. The Riverpoint Development Engineer II will develop systems, processes, methodologies as well as product development to enhance our product offering. Transforming concepts into prototypes for testing, validation, and improvement for production.
Responsibilities:
Plan, conduct, and manage design and development projects for medical devices in support of the company's strategic plan. Leads to the development of new patient specific products and associated manufacturing processes.Maintain productive and respectful dialogue with customers to determine product requirements and ensure customer needs are met. Determines project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.Completes technical studies and prepares cost estimates.Manage compliance, quality control, and quality assurance standards and specifications.Mentor, lead, and coach other members of the engineering staffEngage outside contracting services in support of project needs, i.e., analytical laboratories, consultants, material suppliers and equipment suppliers. Build effective relationships with these resources to meet delivery and budgetary goals.Research and understand device functionality, device patents, and clinical use.Design and develop products in full compliance with the Riverpoint Medical Design Control requirements per SOP820.030, and maintain design files for company products, including testing, testing reports, verification, validation, design files, and design reviews.Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Requirements:
Bachelor’s degree in Mechanical, Materials Science, Chemical, Electrical or Biomedical engineering 3-5 years of experience working in a controlled manufacturing or development environment2-5 years of experience working in an FDA regulated industry/field, or similar.Preferred Experience:
Experience working in an FDA regulated industry/field or similarExposure to the FDA 510(k) process or other regulatory submissions preferred.Experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development preferred.We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays. We also reward our team with bonus pay such as referral an annual bonus.
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
Riverpoint Medical in Northeast Portland is hiring a Manufacturing Engineer II. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. As a full-time Manufacturing Engineer II, you will be responsible for developing, maintaining, and improving production, process methods, support documentation systems, tooling, equipment, and production facility maintenance. This position works closely with the Product Development and Quality Assurance / Regulatory Affairs team to strengthen Riverpoint Medical’s quality system and quality culture. If your passion is to provide hands-on production floor support as well as perform critical thinking analytical work, apply today.
Duties and Responsibilities:
Coordinates and directs the development of cost / quality improvement efforts for in-house production. Creates, maintains, and improves manufacturing process and assembly documentation procedures for employee training, maintaining consistent production and quality performance, and meeting quality system requirements. Coordinates, directs, and project-manages the design, specification development, cost justification, and vendor selection for equipment purchases, off the shelf, semi-automated, and fully automated.Designs jigs and fixtures to support the assembly cells, sterilization, QA, and final product packaging operations. Plans, coordinates, and directs the development of new production capacity initiatives to support the company’s business / sales plan. Includes planning and maximizing production area and cell layouts.Provides work assignment direction and oversight for equipment / facility maintenance staff. Assists, reviews, and approves calibration and maintenance records. Coordinates and supports QA in implementing relevant area compliance with regards to quality (ISO13485), safety, environmental (ISO 14644), and Riverpoint Medical standard procedures.Assists in process investigations of complaints, root cause assessments, nonconformity (NCR), and corrective and preventive action (CAPA) activities.Education and Qualifications:
Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering or other related field of study or equivalent work experienceMinimum 3 years of experience providing direct daily production support in a high-mix, high and low volume, ISO regulated production environment.Production support experience supporting a FDA regulated environment is highly desirable, along with an understanding of cGMP, QSR, and ISO 13485.Experience with LEAN initiatives and AutomationDemonstrated computer skills. Preferably in Solidworks, Microsoft Word and Excel at an intermediate to advanced proficiency level. Ability to write Excel VBA macros and / or Microsoft Access or other database software programming skills are desirable.Demonstrated technical writing skills.Must be able to work in a cleanroom and gown up, lift 35 lbs, and stand on feet for extended periods of time.We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 8 company paid holidays. We also reward our team with bonus pay such as Retention Bonus, Referral Bonus and Annual Bonus!
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
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