Product Engineer - R&D Support

Job Title: Product Engineer – R&D Support

Location: Roseville, MN
Department: Research & Development / Engineering
Salary: $60,000 -$75,000 DOQ

Position Summary:

We are seeking a highly motivated and technically skilled Product Engineer to support R&D initiatives within our medical device manufacturing organization. This role is responsible for leading the development of innovative, manufacturable, and cost-effective product designs using Design for Manufacturing (DFM) principles. The Product Engineer will act as the technical lead on major development projects, ensuring alignment across engineering activities, external consultants, and manufacturing teams.

Key Responsibilities:

• Lead R&D Projects: Serve as the technical lead and project coordinator for major R&D initiatives, ensuring engineering efforts are strategically aligned and executed on schedule.
• Design & Process Development:
  • Utilize DFM principles to develop robust product designs and scalable manufacturing processes.
  • Create and revise 3D models and technical drawings using SolidWorks and AutoCAD.
  • Design, build, and improve manufacturing equipment to enhance product quality and process efficiency.
• Collaborate with Consultants & Cross-functional Teams:
  • Coordinate with a network of engineering consultants to support product development and manufacturing readiness.
  • Lead and participate in activities such as prototyping, pilot production, risk assessments, and design verification/validation.
• Regulatory & Quality Compliance:
  • Support design history file (DHF) creation and ensure adherence to FDA Design Controls, ISO 13485, and other applicable regulatory standards.
  • Conduct design risk assessments (e.g., FMEA) and ensure design input/output traceability.
• Process Validation & Improvement:
  • Develop and validate manufacturing processes, equipment, and tooling.
  • Recommend and implement design and process improvements based on analysis of non-conformances and production feedback.

Qualifications:

• Education:
  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline.
• Experience:
  • 3+ years of experience in a product development or manufacturing engineering role, preferably in the medical device industry.
  • Proficient in SolidWorks and AutoCAD.
  • Demonstrated experience in manufacturing equipment design, fabrication, and continuous process improvement.
  • Strong understanding of FDA regulations, ISO 13485, and medical device design controls.
  • Experience in prototyping, process validation (IQ/OQ/PQ), and risk management (e.g., FMEA).
• Skills & Competencies:
  • Highly developed mechanical aptitude and strong problem-solving skills.
  • Excellent verbal and written communication skills.
  • Ability to work both independently and in cross-functional teams.
  • Detail-oriented with strong organizational skills and ability to manage multiple priorities.

Preferred Qualifications:

• Six Sigma or Lean Manufacturing certification.
• Experience with statistical analysis tools (e.g., Minitab).
• Hands-on experience with pilot-scale production and transfer to manufacturing.

Join our mission-driven team and help shape the future of medical device innovation. Apply your technical expertise to improve lives through advanced engineering solutions.