Manufacturing Process Engineer

We are hiring Manufacturing Process Engineer.

Client:
Major Medical Device Client

Position:
Manufacturing Process Engineer

Duration: 12+ Months Contract

Location:
Waltham, MA 02451

Pay Rate: $45.00-$54.00/ Hr on W2

Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ), specifically related to medical device capital equipment.

• Proficient in use of Minitab, or similar statistical software.
• Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause investigation.

• Six Sigma Green Belt or Black Belt might be helpful.
• Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ).
• Demonstrated experience supporting both internally developed and externally sourced manufacturing processes within regulated environments.
• Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause investigation.
• Proficient in use of Minitab, or similar statistical software.
• Working knowledge of risk management and design control methodologies, including FMEA, control plans, and design transfer activities.
• Experience with complex medical device manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and/or injection molding preferred.
• Familiarity with electro‑mechanical and capital equipment manufacturing processes preferred.
• Ability to troubleshoot complex manufacturing and process‑related issues and implement effective corrective and preventive actions.
• Ability to read, understand, and create engineering drawings using common engineering software, including GD&T interpretation for tight‑tolerance components.
• Ability to conduct complex statistical, geometric, and mathematical calculations.
• Ability to conduct responsibilities substantially free from routine supervision.
• Demonstrated commitment to patient safety, product quality, and compliance with applicable quality systems and regulatory requirements.
• Ability to adopt and defend technical positions in an open and collaborative environment.
• Demonstrated project and task management skills across multiple concurrent initiatives.
• Strong technical communication skills, including the ability to write and review protocols, reports, specifications, and technical documentation.