Konik · 2 months ago
Principal Design Assurance Engineer
Maple Grove, MN, United States
Full-time
Onsite
Senior Level, Lead/Staff
$140K/yr - $160K/yr
10+ years expKonik is a company that specializes in connecting technical talent with employers, and they are seeking a Principal Design Assurance Engineer to provide strategic and technical leadership in ensuring medical device designs meet quality and regulatory requirements. The role involves influencing product development strategies, mentoring engineers, and collaborating with cross-functional teams to deliver compliant and reliable medical devices.
EmploymentHuman ResourcesRecruitingStaffing Agency
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
Qualification
Required
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
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
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.
Company
Konik
Company History: As a leading technical staffing agency in the Midwest, Konik makes the hiring process more personal by forming true connections and treating everyone like family—a value imparted by our founders and instilled in every team member.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Brad Konik
Chief Executive Officer
Company data provided by crunchbase