Lead Mechanical Engineer, Medical Devices R&D

Gilder Search Group; Minneapolis (MN); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Competitive base salary

Medical, dental, and vision coverage

401(k) with employer match

Paid time off and holidays

Professional development opportunities

Job summary

Konik partners with a leading medical device manufacturer to recruit a Principal Mechanical Engineer for a 100% onsite role in Minneapolis, MN. You will guide sustaining engineering, drive design changes, and ensure regulatory and manufacturing standards are met.

The ideal candidate has 5+ years in Class II/III disposable medical product development, strong plastics processing knowledge, and proficiency with CAD tools like SolidWorks or Creo. Direct-hire, competitive salary range offered.

Qualifications

• BS in Mechanical/Plastics/Biomedical Engineering; MS preferred.
• 5+ years in Class II/III disposable medical product development.
• Strong knowledge of plastics processing and FDA Design Controls.

Responsibilities

• Lead design changes for disposable medical devices within sustaining engineering.
• Manage project schedules and budgets with minimal supervision.
• Serve as technical expert for supplier, materials, labeling, CAPA/NCR, cost reduction, and remediation.
• Investigate and resolve complex engineering challenges using DFMEA and CAD tools.
• Create and maintain design history files per FDA/ISO standards.
• Coordinate with R&D and global stakeholders throughout the lifecycle.
• Provide mentorship and technical guidance to engineers and technicians.
• Contribute to IP via invention disclosures and patent submissions.

Skills

Leadership

Problem-solving

Communication

Mentoring

Education

Bachelor’s degree in Mechanical/Plastics/Biomedical Engineering

Master’s degree preferred

Tools

SolidWorks

Creo

PDM systems

Job description

Konik partners with a leading medical device manufacturer to recruit a Principal Mechanical Engineer for a 100% onsite role in Minneapolis, MN. You will guide sustaining engineering, drive design changes, and ensure regulatory and manufacturing standards are met.

The ideal candidate has 5+ years in Class II/III disposable medical product development, strong plastics processing knowledge, and proficiency with CAD tools like SolidWorks or Creo. Direct-hire, competitive salary range offered.