Senior Design Assurance Engineer

Senior Design Assurance Engineer

Maple Grove, MN | Direct-Hire | $105,000–$135,000 | Onsite

Konik is working with a medical device client who is seeking a Senior Design Assurance Engineer to provide technical leadership and ensure that new and existing medical device designs meet the highest standards of quality, safety, and regulatory compliance. This role is central to the product development lifecycle, partnering closely with engineering, quality, and regulatory teams to develop, verify, and validate design solutions that improve patient outcomes.

The ideal candidate combines strong technical expertise with a collaborative mindset and a passion for driving continuous improvement in design assurance practices.

• Lead design assurance activities across multiple product development programs, ensuring compliance with internal and external quality standards.
• Collaborate with cross-functional teams to define and implement design control strategies throughout concept, design, verification, and validation phases.
• Develop and maintain risk management documentation including FMEAs, hazard analyses, and control plans.
• Generate and execute test methods, protocols, and reports to verify design performance and regulatory compliance.
• Prepare and review Design History Files (DHF), Device Master Records (DMR), and related technical documentation to support audits and submissions.
• Interpret and apply applicable quality and regulatory standards (FDA, ISO, IEC) during all phases of development.
• Provide technical input during design reviews and offer data-driven recommendations to strengthen product reliability and safety.
• Analyze verification and validation data, ensuring test outcomes support design intent and meet acceptance criteria.
• Stay current on evolving global regulations, standards, and industry best practices related to design assurance and risk management.
• Support and mentor team members by sharing expertise in quality systems and regulatory expectations.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline (Master’s preferred).
• Minimum of 5 years of experience in design assurance, quality engineering, or design controls within the medical device industry.
• Strong working knowledge of design control, risk management, and quality system requirements.
• Experience authoring and reviewing technical documentation for regulatory submissions.
• Proficiency with statistical analysis software and application of statistical methods to validation and verification processes.
• Familiarity with FDA QSR, ISO 13485, ISO 14971, and IEC 60601 standards.
• Excellent written and verbal communication skills with a collaborative, cross-functional approach.
• Proven problem-solving skills with strong attention to detail and analytical reasoning.

• Experience supporting Class II or III medical devices through the full product lifecycle.
• Strong background in verification and validation strategy development.
• Understanding of usability engineering, biocompatibility, and sterilization validation.
• Hands-on experience leading design reviews and addressing CAPA or audit findings.
• Knowledge of DHF/DMR structure and documentation best practices.

• Competitive base salary commensurate with experience.
• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off including vacation, holidays, and personal days.
• Short- and long-term disability, life insurance, and optional voluntary benefits.
• Professional development opportunities in a collaborative, growth-oriented work 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.

$105,000-$135,000 per year