Senior Mechanical Engineer, Medical Devices R&D (Onsite)

Konik; Minneapolis (MN); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Competitive base salary

Medical, dental, vision

401(k) with company match

Paid time off

Professional development

Job summary

Konik is partnering with a leading manufacturer of disposable medical devices to add a Senior Mechanical Engineer to their R&D team in Golden Valley, MN. The role focuses on sustaining engineering, design change programs, and ensuring product improvements meet regulatory, quality, and manufacturing standards.

You will lead cross-functional teams, mentor engineers, and drive DFMEA, CAD, and FDA/ISO compliance while contributing to IP through invention disclosures.

Qualifications

• Bachelor's degree in Mechanical, Plastics, Biomedical Engineering or related field.
• 5+ years in Class II/III disposable medical device development.
• Strong knowledge of CAD, plastics processing, and regulatory requirements (FDA/ISO).

Responsibilities

• Lead design changes for disposable medical devices within sustaining engineering.
• Manage project schedules and budgets with minimal supervision.
• Act as technical leader for suppliers, materials, labeling, CAPA/NCR, and cost-reduction initiatives.
• Apply DFMEA, Human Factors, statistics, and CAD tools to solve complex problems.
• Maintain and ensure DHF compliance per FDA/ISO standards.
• Coordinate with R&D and cross-functional teams through product lifecycle.
• Mentor engineers and technicians as needed.
• Contribute to IP via invention disclosures and patents.

Skills

Mechanical Eng

Regulatory Compliance

CAD Software

Plastics Processing

Leadership

Education

B.S. Mechanical Eng

Tools

SolidWorks

Creo

PDM Systems

Job description

Konik is partnering with a leading manufacturer of disposable medical devices to add a Senior Mechanical Engineer to their R&D team in Golden Valley, MN. The role focuses on sustaining engineering, design change programs, and ensuring product improvements meet regulatory, quality, and manufacturing standards.

You will lead cross-functional teams, mentor engineers, and drive DFMEA, CAD, and FDA/ISO compliance while contributing to IP through invention disclosures.