Principal R&D Engineer (NPD)
Minneapolis, MN | Direct Hire | $120,000-$150,000 Base Salary
Konik is partnering with an established medical device manufacturer seeking a Principal R&D Engineer (NPD) to support the design, development, and improvement of disposable medical products. This role will lead complex engineering initiatives involving new product development, product modifications, material changes, and manufacturing improvements.
The ideal candidate will bring a strong background in medical device engineering, plastics processing, and design controls, with experience developing Class II or Class III disposable medical products. This individual will take ownership of engineering projects, provide technical direction to cross-functional teams, and ensure product designs meet performance, quality, and regulatory requirements.
This is an excellent opportunity for an experienced engineer who enjoys solving complex technical challenges, influencing product development decisions, and contributing to innovative medical technologies.
Principal R&D Engineer (NPD)Responsibilities
- Lead engineering projects from initial concept through design development, testing, and implementation while managing project schedules, budgets, and deliverables.
- Serve as a technical resource for new product development and design changes involving materials, suppliers, manufacturing processes, labeling, cost reduction, and product remediation.
- Investigate complex engineering challenges and develop solutions using risk assessment, design FMEAs, human factors principles, CAD, and other engineering tools.
- Lead the development and maintenance of design history files and ensure compliance with applicable design controls, quality systems, and regulatory requirements.
- Collaborate with global R&D, Manufacturing, Quality, Regulatory, and other cross-functional teams to coordinate engineering activities and resolve technical challenges.
- Identify technical risks, develop mitigation strategies, and drive continuous improvement throughout the product development lifecycle.
- Provide technical guidance and mentorship to engineers and technicians while supporting intellectual property and product innovation initiatives.
Principal R&D Engineer (NPD)Qualifications
- Bachelor's degree in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or a related technical field; master's degree preferred.
- 8+ years of experience in medical device product development, specifically involving Class II or Class III disposable medical products.
- Advanced knowledge of plastics materials and manufacturing processes, including injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
- Strong understanding of FDA design controls, ISO 13485 quality systems, and ISO 14971 medical device risk management requirements.
- Working knowledge of CAD design and product data management (PDM) systems, such as Creo or SolidWorks.
- Experience with design risk assessments, dFMEAs, technical documentation, and engineering change processes.
- Strong project management, problem-solving, and communication skills, with the ability to influence cross-functional teams and manage multiple priorities.
- Demonstrated ability to work independently, mentor others, and drive engineering improvements.
Principal R&D Engineer (NPD)Preferred Qualifications
- Experience leading complex medical device development or product modification programs.
- Experience with human factors engineering and statistical analysis tools.
- Experience working with global engineering and manufacturing teams.
- Previous technical leadership or mentorship experience.
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.
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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.
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