Principal Design Assurance Engineer

Principal Design Assurance Engineer
Maple Grove, MN | Direct-Hire | $140,000–$160,000 | Onsite

We are seeking a Principal Design Assurance Engineer to provide strategic and technical leadership in ensuring that medical device designs meet all applicable quality, safety, and regulatory requirements. This individual will serve as a subject matter expert in design controls, risk management, and compliance processes across the full product lifecycle—from concept through commercialization.

In this role, you will influence product development strategies, mentor engineers, and partner closely with cross-functional teams to deliver innovative, compliant, and reliable medical devices. The ideal candidate is both a hands-on technical expert and a collaborative leader who can translate complex regulatory requirements into practical, value-driven design assurance practices.

Key Responsibilities

• Provide technical leadership for design assurance activities across multiple, concurrent product development programs.
• Serve as a subject matter expert in design control, risk management, and product validation, guiding teams through all phases of development and sustaining engineering.
• Lead the development, review, and approval of Design History Files (DHF), Device Master Records (DMR), and risk management documentation in compliance with FDA, ISO, and IEC standards.
• Partner with R&D and Systems Engineering to ensure design inputs and outputs are clearly defined, traceable, and verifiable.
• Develop and implement verification and validation strategies, ensuring comprehensive test coverage and alignment with design requirements.
• Analyze testing and field performance data to identify systemic risks and drive continuous improvement initiatives.
• Participate in internal and external audits, regulatory inspections, and technical reviews, providing expert interpretation of quality system and regulatory expectations.
• Mentor and train team members in quality system processes, risk management, and design assurance best practices.
• Stay current with emerging regulations, standards, and global quality system requirements; proactively integrate these changes into company procedures.
• Collaborate cross-functionally with Quality, Regulatory, Operations, and Project Management to ensure robust product realization processes.

Minimum Qualifications

• Bachelor’s degree in Mechanical, Engineering, Biomedical Engineering, or a related technical discipline (Master’s preferred).
• Minimum of 10 years of experience in design assurance, quality engineering, or product development within the medical device industry.
• Deep understanding of design control principles, risk management, and product lifecycle management for Class II and III devices.
• Proven success developing and executing verification and validation plans, including statistical analysis and sample size justification.
• Extensive knowledge of FDA QSR, ISO 13485, ISO 14971, and IEC 60601 standards and their application in product development.
• Demonstrated experience supporting regulatory submissions (510(k), PMA, or MDR technical files).
• Proficiency in statistical software tools (e.g., Minitab) and data-driven decision-making methods.
• Exceptional communication skills with the ability to influence and guide cross-functional teams and stakeholders.
• Strong organizational, analytical, and problem-solving skills with a focus on process improvement and efficiency.

Preferred Skills

• Prior experience leading design assurance teams or serving as a technical lead across multiple development programs.
• Familiarity with software validation, usability engineering, and human factors testing.
• Proven ability to lead risk-based decision-making within cross-functional teams.
• Experience managing CAPA investigations, audit responses, or post-market surveillance initiatives.
• Advanced training or certification in quality systems or risk management (e.g., ASQ CQE, RAC, ISO 14971).

Benefits & Compensation

• Competitive compensation package based on experience and qualifications.
• Comprehensive health, dental, and vision coverage.
• 401(k) plan with company match.
• Paid holidays, vacation, and personal time off.
• Short- and long-term disability, life insurance, and additional voluntary benefits.
• Professional growth opportunities within an innovative and collaborative team environment.

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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.

Compensation:
$140,000-$160,000 per year