Manufacturing Process Engineer

We are hiring Manufacturing Process Engineer.

Please let me know if you are interested or anyone who might be interested.

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

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Description:

MUST HAVES:

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.

NICE TO HAVES:

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.

Regards

Vishnu Das Natesan

dvishnu@radiants.com