Job Title: Manufacturing / Process Development Engineer - Nitinol & Advanced Metals
Location: Onsite; Osseo, MN
Salary: ~$80k-120k PLUS 15% bonus
OverviewThis role is ideal for an engineer who loves learning new processes, solving technical challenges, and working hands-on with advanced manufacturing technologies. You'll collaborate closely with cross-functional teams to develop and optimize manufacturing processes for metal-based medical components. If you're curious, collaborative, and eager to expand your technical depth, you'll thrive in our innovative, fast-paced environment.
Key Responsibilities- Coordinate product and process enhancements with customers and internal project teams.
- Develop and maintain comprehensive manufacturing documentation, including timelines, responsibilities, protocols, IQ/OQ/PQ reports, bills of materials (BOMs), assembly and manufacturing instructions, and validation procedures.
- Collaborate with Quality and Supply Chain teams to ensure compliance with QSR and internal quality standards.
- Review design inputs to determine BOM requirements; partner with Supply Chain to source and cost materials (internal and external).
- Participate in customer communications, technical reviews, and sustaining engineering activities.
- Support the resolution of product complaints, nonconformances, or safety issues.
- Help plan and execute component and device testing methods and protocols, ensuring statistical relevance and compliance with applicable standards.
- Identify and mitigate manufacturing risks through participation in pFMEA and other risk assessments.
- Support process qualification and validation, tooling, and equipment development, including data collection, analysis, labor/yield metrics, and process capability studies.
- Transfer validated processes and projects from development into manufacturing.
Special Focus Areas- Provide expertise in the post-processing of Nitinol, Stainless Steel, and Cobalt-Chromium alloys, including forming, heat treatment, electropolishing, and surface finishing processes.
- Contribute to the continuous improvement of metal component manufacturing, leveraging knowledge of materials behavior and precision fabrication.
Requirements- Bachelor's Degree in Engineering (e.g., Mechanical, Materials, or Biomedical) and 1-3 years of related experience (or equivalent combination of education and experience).
- Proven understanding of manufacturing process development, materials science, and validation principles.
- Excellent communication, organization, problem-solving, and analytical skills.
- Commitment to quality, continuous improvement, and cross-functional collaboration.
- Strong attention to detail, ability to manage multiple projects, and enthusiasm for a dynamic, growth-oriented environment.
- Working knowledge of data collection, analysis, and scientific methodology applied to process improvement.
