Matlen Silver is looking for Process Engineer - Medical Device Manufacturing in Waltham, MA.
This local job opportunity with ID 3700392704 is live since 2026-06-03 23:04:49.
Position Title: Process Engineer – Medical Device Manufacturing
Location: Waltham Massachusetts 02451
Duration: 12 Months (Possible Extension/Conversion)/ No C2C
Due to client requirements this role is only open to USC OR GC candidates
Position Overview
Client is seeking a skilled Process Engineer to support the development, transfer, optimization, and validation of medical device manufacturing processes in a regulated environment. The ideal candidate will have strong technical expertise in process engineering, statistical analysis, and manufacturing operations, with a focus on ensuring product quality, compliance, and continuous improvement.
Key Responsibilities
- Develop, optimize, transfer, and validate manufacturing processes, including IQ/OQ/PQ activities.
- Support both internally developed and externally sourced manufacturing processes.
- Apply statistical methods and data-driven problem-solving techniques, including DOE, process capability analysis, and root cause investigations.
- Utilize Minitab or similar statistical software for process analysis and reporting.
- Participate in risk management and design control activities, including FMEA, control plans, and design transfer.
- Troubleshoot complex manufacturing and process-related issues and implement corrective and preventive actions (CAPA).
- Create, review, and maintain engineering documentation, including protocols, reports, specifications, and technical drawings.
- Interpret GD&T and engineering drawings for tight-tolerance components.
- Collaborate cross-functionally to support manufacturing efficiency, product quality, and regulatory compliance.
- Manage multiple projects and priorities in a fast-paced environment.
Qualifications
- Strong understanding of medical device manufacturing process development and validation.
- Experience working within regulated manufacturing environments.
- Knowledge of statistical analysis and process characterization methodologies.
- Proficiency with Minitab or equivalent statistical software.
- Familiarity with risk management and design control principles.
- Strong technical communication and documentation skills.
- Ability to work independently with minimal supervision.
Preferred Qualifications
- Experience with catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and/or injection molding.
- Familiarity with electro-mechanical and capital equipment manufacturing processes.
About Matlen Silver
Experience Matters. Let your experience be driven by our experience. For more than 40 years, Matlen Silver has delivered solutions for complex talent and technology needs to Fortune 500 companies and industry leaders. Led by hard work, honesty, and a trusted team of experts, we can say that Matlen Silver technology has created a solutions experience and legacy of success that is the difference in the way the world works.
Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: info@matlensilver.com // 908-393-8600
At The Matlen Silver Group, Inc., W2 employees are eligible for the following benefits:
- Health, vision, and dental insurance (single and family coverage)
- 401(k) plan (employee contributions only)
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