Principal R&D Engineer

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

100% Onsite

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 projects.

Principal Mechanical Engineer

Golden Valley, MN | Direct-Hire | $120,000 – $145,000 (Flexible) | 100% Onsite

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 projects.

Senior Mechanical Engineer 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, customer-focused approaches and engineering tools (DFMEA, Human Factors Engineering, statistical analysis, CAD).
• Create, maintain, and ensure compliance of design history files in alignment with FDA and ISO standards.
• Coordinate and communicate with R&D and global cross-functional stakeholders throughout the product lifecycle.
• Provide mentorship and technical guidance to engineers and technicians as needed.
• Contribute to the company’s intellectual property via invention disclosures and patent submissions.
  
  

Senior Mechanical Engineer Qualifications

• Bachelor’s degree in Mechanical, Plastics, Biomedical Engineering, or a related field; Master’s preferred.
• 5+ years of experience in Class II or Class III disposable medical product development.
• Advanced knowledge of plastics materials and processing (injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization).
• Strong understanding of FDA Design Controls and ISO 13485 Quality Management Systems.
• Proficiency with CAD design software (SolidWorks, Creo) and PDM systems.
• Knowledge of ANSI/AAMI/ISO 14971 standards for medical device risk management.
• Strong problem-solving, communication, and leadership skills; ability to train and mentor team members.
• Demonstrated ability to implement best practices, innovation, and continuous improvement initiatives.
• Willingness to work in a flexible workplace environment with a minimum of 3 days onsite per week.
  
  

Benefits

• Competitive base salary with potential performance-based incentives.
• Comprehensive medical, dental, and vision coverage.
• 401(k) with employer match.
• Paid time off and company holidays.
• Professional development and training opportunities.
  
  

Be the first to learn about future positions by joining our Newsletter and following us on LinkedIn !

Konik is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

Konik has been creating impactful relationships between technical talent and employers for more than 50 years. Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception, and maintains a strong commitment to customer service.

Manufacturing