Role: R&D Sustaining Engineer

Location: Minneapolis, MN (Onsite)

Overview:

The R&D Sustaining Engineer will support ongoing product lifecycle activities by driving design changes, managing documentation updates, and ensuring compliance across multiple functional teams. This role is highly focused on change management, vendor collaboration, and maintaining product and process integrity within a regulated medical device environment.

Key Responsibilities:

• Partner with cross-functional teams (R&D, Quality, Operations, Vendors) to evaluate and implement product and process changes.
• Review, approve, and execute Engineering Change Orders (ECOs) / Change Notices (CNs) in Windchill.
• Gather and analyze vendor-supplied data to support design changes and compliance needs.
• Develop and update design change analyses, documentation, prints, standards, labeling, and packaging materials.
• Support creation and review of DV (Design Verification) protocols, DV reports, and other sustaining engineering documentation.

Preferred Experience:

• Strong blend of electrical and mechanical engineering skills.
• R&D or Sustaining Engineering experience within medical devices —catheter experience is a strong plus.
• Solid background in change management , documentation control, and quality/compliance processes.
• Systems engineering exposure, especially supporting capital equipment or complex electromechanical systems.