Senior Mechanical Engineer, Medical Devices — Onsite R&D

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

Benefits offered by this job

Competitive base salary with bonuses

Medical, dental, and vision coverage

401(k) with employer match

Paid time off and holidays

Professional development opportunities

Job summary

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

The ideal candidate will bring deep expertise in medical device design, plastics processing, and regulatory compliance while guiding cross-functional teams in executing complex engineering

Qualifications

• Bachelor’s degree in Mechanical/Plastics/Biomedical Engineering; Master’s preferred.
• 5+ years of disposable medical product development experience (Class II/III).
• Advanced plastics materials & processing knowledge (injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization).
• Strong understanding of FDA Design Controls and ISO 13485 Quality Management Systems.
• Proficiency with CAD tools (SolidWorks, Creo) and PDM systems.

Responsibilities

• Lead the design and development of product changes for disposable medical devices within sustaining engineering.
• Manage project schedules and budgets while delivering design change programs with minimal supervision.
• Serve as technical expert for supplier, materials, labeling, CAPA/NCR, cost reduction, and remediation initiatives.
• Investigate and resolve complex engineering challenges using risk-based approaches and tools (DFMEA, Human Factors Engineering, CAD).
• Create, maintain, and ensure compliance of design history files per FDA and ISO standards.
• Coordinate with R&D and global cross-functional stakeholders throughout the product lifecycle.
• Provide mentorship and technical guidance to engineers and technicians.
• Contribute to the company’s IP via invention disclosures and patent submissions.

Skills

Medical device design

Regulatory compliance

Leadership

Project management

Risk management (DFMEA)

Education

Bachelor’s degree in Mechanical/Plastics/Biomedical Engineering

Master’s degree preferred

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. This role focuses on sustaining engineering, leading design change programs, and ensuring product improvements meet strict regulatory, quality, and manufacturing standards.

The ideal candidate will bring deep expertise in medical device design, plastics processing, and regulatory compliance while guiding cross-functional teams in executing complex engineering