Principal R&D Engineer
$120,000–$145,000 year
On-siteMinneapolis, Minnesota, United States
Job Summary
Lead design and development of product changes for disposable medical devices within sustaining engineering, managing project schedules and budgets with minimal supervision. Serve as technical expert for supplier, materials, labeling, CAPA/NCR, cost reduction, and remediation initiatives while investigating complex engineering challenges using risk-based, customer-focused approaches. Create and maintain design history files in alignment with FDA and ISO standards, coordinating with global cross-functional stakeholders throughout the product lifecycle. Provide mentorship to engineers and technicians, contribute to intellectual property via invention disclosures and patent submissions, and implement continuous improvement initiatives. Apply advanced knowledge of plastics processing and regulatory compliance to guide cross-functional teams in executing complex engineering projects.
Required Qualifications
- Bachelor's degree in Mechanical, Plastics, Biomedical Engineering, or a related field
- 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
Desired Qualifications
- Master's degree
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