Manufacturing / Process Development Engineer - Nitinol & Advanced Metals
Job Description
Job Description
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
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Coordinate product and process enhancements with customers and internal project teams.
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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.
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Collaborate with Quality and Supply Chain teams to ensure compliance with QSR and internal quality standards.
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Review design inputs to determine BOM requirements; partner with Supply Chain to source and cost materials (internal and external).
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Participate in customer communications, technical reviews, and sustaining engineering activities.
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Support the resolution of product complaints, nonconformances, or safety issues.
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Help plan and execute component and device testing methods and protocols, ensuring statistical relevance and compliance with applicable standards.
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Identify and mitigate manufacturing risks through participation in pFMEA and other risk assessments.
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Support process qualification and validation, tooling, and equipment development, including data collection, analysis, labor/yield metrics, and process capability studies.
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Transfer validated processes and projects from development into manufacturing.
Special Focus Areas
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Provide expertise in the post-processing of Nitinol, Stainless Steel, and Cobalt-Chromium alloys, including forming, heat treatment, electropolishing, and surface finishing processes.
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Contribute to the continuous improvement of metal component manufacturing, leveraging knowledge of materials behavior and precision fabrication.
Requirements
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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).
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Proven understanding of manufacturing process development, materials science, and validation principles.
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Excellent communication, organization, problem-solving, and analytical skills.
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Commitment to quality, continuous improvement, and cross-functional collaboration.
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Strong attention to detail, ability to manage multiple projects, and enthusiasm for a dynamic, growth-oriented environment.
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Working knowledge of data collection, analysis, and scientific methodology applied to process improvement.
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