Senior Process Engineer

Process / Manufacturing Engineer – Medical Devices (Contract)

💲 Up to $75/hour

We’re seeking a hands‑on Process / Manufacturing Engineer to support new product development and the launch of a new low‑volume assembly line within a regulated medical device environment.

This role is ideal for a strong communicator who can collaborate across three global sites and bring at least five years of experience to proactively identify risks, apply best practices, and help drive a smooth design transfer into manufacturing.

You’ll play a key role in developing operator‑heavy manual and semi‑automated assembly processes while working closely with Design Engineering, Quality, and Program Management — with regular time spent on the production floor.

• Provide DFA / DFM feedback during product development and design reviews
• Support design transfer from R&D into manufacturing, including pilot builds and ramp‑up
• Develop and optimize manual or semi‑automated low‑volume assembly lines and equipment
• Lead or support IQ/OQ/PQ process validation activities
• Develop pFMEAs, control plans, and risk documentation
• Create and maintain work instructions and process documentation with operator input
• Partner with vendors to design, build, and qualify assembly fixtures and equipment
• Design and manage layouts, workflows, and material flow within a mini production facility

• Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related field
• 5+ years of Process or Manufacturing Engineering experience (medical device or other regulated environment preferred)
• Experience supporting new product development, NPI, or assembly line launches
• Strong understanding of manual assembly and operator‑heavy processes
• Experience with process validation and statistical methods
• pFMEA and risk documentation experience preferred

If you enjoy building processes from scratch, improving operator‑driven workflows, and working at the intersection of design and manufacturing, this could be a great fit.