US - Manufacturing Engineer-Sr

Job Description

Job Description

Job Title Manufacturing Engineer - Sr
Location: Maple Plain, MN
Duration: 06 Months

Experience:
• Understand manufacturing metrics and continuous improvement tools (e.g., Lean, DMAIC)
• Hands-on experience scaling products from prototype to production is a benefit
• Skilled in fixture/tooling design and implementation

Skills:
• Strong CAD and problem-solving skills
• Familiarity with regulated medical device environments
• Strong problem-solving skills, attention to detail, self-starter with proven ability to successfully work with minimal supervision
• Good teamwork and interpersonal skills
• Good written and verbal communication
• Ability to multitask, prioritize, and meet project deadlines with high attention to detail
• SolidWorks proficiency desired
• Familiarity with 5S and DMADV

Responsibilities:
• Manage special projects and initiatives as assigned, driving them from planning through implementation and final completion
• Lead development and optimization of manufacturing processes for soft-tissue repair device systems
• Drive design for manufacturability (DFM) and transfer of robust processes into high-volume production
• Develop and validate equipment, fixtures, and tooling for assembly and inspection
• Partner cross-functionally with R&D, Quality, and Supply Chain to resolve technical issues and improve output
• Execute structured root-cause analysis and corrective actions for production challenges
• Support process validations, change controls, and documentation in compliance with ISO 13485/FDA QSR

Position Summary:
This is an exciting opportunity for a well-rounded engineer to join a small team supporting a recently acquired medical device startup. As a Manufacturing Engineer, you will support the development, validation, and scale-up of manufacturing processes for our innovative surgical device—directly contributing to product quality, efficiency, and patient outcomes. In all actions, the Manufacturing Engineer will demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented processes and procedures.

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