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.
Key Responsibilities
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
Qualifications
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.
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