Product Development Engineer

SkyWater Search Partners; Maple Grove (MN); On-site; USD 85,000 - 125,000; Full time

Job summary

SkyWater Search Partners partners with a rapidly growing medical device contract manufacturer specializing in advanced catheter technologies. The Product Development Engineer will serve as the technical lead on catheter development programs, driving projects from concept to market release.

You will collaborate cross-functionally and interface directly with customers to ensure quality, timeline, and performance, while maintaining FDA QSR and ISO 13485 compliance.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering (or equivalent experience).
• 3-10 years of medical device product development experience. Catheter Design experience required.
• Demonstrated experience bringing products from concept to market
• Working knowledge of FDA QSR and ISO 13485 regulations
• Proficiency in SolidWorks

Responsibilities

• Lead product development efforts from concept through commercialization
• Design and develop catheter systems including reinforced shafts, delivery systems, and steerable technologies
• Conduct feasibility studies, risk analysis, and validation activities (IQ/OQ/PQ)
• Generate and maintain detailed design documentation per FDA QSR and ISO 13485
• Prepare project plans and manage timelines, resources, and deliverables
• Interface directly with clients to answer technical questions and provide updates
• Coordinate with suppliers and internal manufacturing teams

Skills

Excellent communication skills

Customer-facing experience

Project leadership

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

We are partnering with a rapidly growing, vertically integrated medical device contract manufacturer specializing in advanced catheter technologies. This team is known for technical depth, speed, and a high-accountability culture. If you thrive in a fast-paced, client-facing environment and want real ownership over your programs, this is a compelling next step.

The Product Development Engineer serves as a technical lead on catheter development programs, driving projects from concept and feasibility through validation and market release. This individual will collaborate cross-functionally while interfacing directly with customers to ensure quality, timeline, and performance expectations are met.

Responsibilities:

• Lead product development efforts from concept through commercialization
• Design and develop catheter systems including reinforced shafts, delivery systems, and steerable technologies
• Conduct feasibility studies, risk analysis, and validation activities (IQ/OQ/PQ)
• Generate and maintain detailed design documentation per FDA QSR and ISO 13485
• Prepare project plans and manage timelines, resources, and deliverables
• Interface directly with clients to answer technical questions and provide updates
• Coordinate with suppliers and internal manufacturing teams

Desired Skills And Experience:

• Bachelor’s degree in Mechanical or Biomedical Engineering (or equivalent experience)
• 3-10 years of medical device product development experience. Catheter Design experience required.
• Demonstrated experience bringing products from concept to market
• Working knowledge of FDA QSR and ISO 13485 regulations
• Proficiency in SolidWorks
• Excellent communication skills and customer-facing experience