Principal R&D Engineer

Konik is partnering with a leading manufacturer of disposable medical devices to add a Principal Mechanical Engineer to their R&D team in Golden Valley, MN. This direct-hire, 100% onsite role focuses on sustaining engineering, leading design change programs, and ensuring product improvements meet strict regulatory, quality, and manufacturing standards.

About the Role

This position is ideal for a candidate with deep expertise in medical device design, plastics processing, and regulatory compliance. You will guide cross-functional teams in executing complex engineering projects while serving as a technical expert for supplier, materials, labeling, CAPA/NCR, cost reduction, and remediation initiatives.

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.

Requirements

• 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.

Pay

$120,000 – $145,000 (flexible) base salary with potential performance-based incentives.

Benefits

• Comprehensive medical, dental, and vision coverage.
• 401(k) with employer match.
• Paid time off and company holidays.
• Professional development and training opportunities.