Senior Process Development Engineer

Senior Process Development Engineer - Medical Device Manufacturing We're partnering with our client, an innovative medical device startup in Minneapolis, Minnesota, to find a Senior Process Development Engineer to join our client's team. This is a key role within Operations, working closely with R&D, Quality, Supply Chain, Commercial and Production to take products from concept through scale-up to full commercialization.

You'll lead process development, new manufacturing line setup, and continuous improvement initiatives that directly impact patient safety and product quality.

Key Skills and Responsibilities Process Development & NPI:
Create, specify and implement scalable, cost-effective processes, fixtures and equipment for Class I & II devices, supporting new product introduction through commercialization.

Manufacturing Line Setup & Scale-Up:
Define manufacturing processes and equipment, develop scale-up projects and ensure capacity grows with customer demand.

Validation & Compliance (IQ/OQ/PQ):
Qualify and validate processes, fixtures and equipment; partner with internal teams and third parties to execute IQ/OQ/PQ in a regulated environment.

Automation & Tooling:
Apply technical knowledge to design and develop tooling, equipment and automation/semi-automation to improve yields, efficiency and cost of goods.

Problem Solving & Continuous Improvement:
Use manufacturing problem-solving tools (e.g. DMAIC) to investigate and own improvement projects, and disposition discrepant product.

Cross-Functional Leadership:
Act as technical point of contact, support design for manufacturability, lead and mentor other engineers and effectively train product builders.

Experience & Technical Background5+ years related experience in medical device or other regulated industry.

Demonstrated development of equipment/fixtures from concept to production.

Experience with CAD (Solid Works preferred) and statistical software (Minitab preferred).Self starter with proven ability to successfully work with minimal supervision.

Demonstrated cross functional teamwork in a technically demanding environment Strong Bias for action and ability to effectively prioritize work and deliver business results in fast paced, constantly changing environment. Ability to work in clean room environment (wear clean room clothing)
If you'd like to help shape advanced manufacturing for a fast-growing medical device startup, we'd be pleased to discuss this opportunity with you.

EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran  addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law.

Eligibility may vary based on factors such as location and hire date and is subject to change.

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