Principal RD Engineer

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

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.

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.

Compensation

$120,000-$145,000 per year