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.
- 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)
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