R&D Component Engineer

Job Title: R&D Component Engineer

This is an exciting opportunity for a well‑rounded engineer to join a small team supporting a recently acquired medical device startup. The R&D Component Engineer I will play a pivotal role in the engineering team, collaborating with representatives from R&D, Quality, Supply Chain, and Production. This position is responsible for evaluating and managing mechanical components used in the manufacturing scale‑up of products.

The R&D Component Engineer I serves as the technical bridge between design, procurement, and manufacturing, ensuring every mechanical part in our instruments is functional, reliable, compliant, and cost‑effective. The role requires a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and other documented processes and procedures.

• Evaluate and approve parts to ensure compliance with requirements.
• Inspect, analyze, potentially rework, review, test, and disposition components to ensure functionality.
• Perform design and project tasks related to the inspection, testing, and production support of implantable orthopedic devices and non‑implantable delivery instruments.
• Assist in research and development of new components, assemblies, and processes to support product development and continuation activities.
• Conduct dimensional, strength of materials, mechanism movement, and manufacturability analysis.
• Generate test methods and protocols, perform tests, analyze data, generate reports for product verification, and present findings to cross‑functional stakeholders.
• Create and support documentation activities including drawings, specifications, change orders, and design reviews.
• Perform various product engineering tasks to support R&D and operations.
• Communicate updates to the program manager and cross‑functional team members regarding task completion and schedule adherence.
• Evaluate and solve technical challenges individually or as part of a team by collaborating cross‑functionally.
• Participate in engineering meetings, technical working groups, and project management discussions.
• Assist in building, prototyping, modifying, and testing engineering components.
• Follow safety protocols, quality SOPs, and regulatory requirements in all tasks and activities.
• Document activities according to best engineering practices, company procedures, and regulatory requirements.

• Bachelor's degree in engineering (Mechanical, Manufacturing, Industrial, Biomedical, or technical equivalent) with 0‑3 years of related work experience or an equivalent combination.
• Hands‑on experience in metrology and familiarity with metrological equipment.
• Experience in analytical methods including statistics, DOE, and associated software tools (Minitab).
• Strong problem‑solving skills, attention to detail, and ability to work both independently and as a team.
• Self‑starter with proven ability to work successfully with minimal supervision.
• Excellent teamwork and interpersonal skills.
• Good written and verbal communication skills.
• Ability to multitask, prioritize, and meet project deadlines with high attention to detail.

• Hands‑on experience with prototyping tools (3D printing, hand and/or power tools, manual and/or CNC machining, etc.), measurement tools (Keyence, Micro‑Vu), and mechanical testing equipment.
• Working knowledge of current CAD tools, with Solid Works experience preferred.
• Experience working within an ISO certified or FDA registered work environment.
• Familiarity with medical device quality systems and regulations.
• Demonstrated cross‑functional teamwork in technically demanding environments.

The position is onsite with standard hours from 8‑5. There may be some flexibility to accommodate traffic if necessary. The work involves supporting a tool used for rotator cuff surgery that is FDA approved, with current production around 100 units per month and plans to expand significantly in the next year.

This is a Contract position based out of Maple Plain, MN.

The pay range for this position is $35.00 - $55.00/hr.

Eligibility…