Job Title: Manufacturing / Process Development Engineer - Nitinol & Advanced Metals
Location: Onsite; Osseo, MN
Salary: ~$80k-120k PLUS 15% bonus
Overview
This 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.