Process Engineer – Medical Device Manufacturing

Position Title: Process Engineer – Medical Device Manufacturing

Location: Waltham Massachusetts 02451

Duration: 12 Months (Possible Extension/Conversion) / No C2C

Eligibility: Due to client requirements this role is only open to USC OR GC candidates

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.

• 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.

• 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.

• 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.

• Health, vision, and dental insurance (single and family coverage)
• 401(k) plan (employee contributions only)

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.