Design Assurance Engineer

You can count on Nonin. Our vision is to improve people’s lives by creating noninvasive medical devices people can count on, even in challenging conditions. Nonin’s culture is grounded in our mission and vision, and our values are reflected in our commitment to diversity, equity, and inclusion. Diversity, Equity, and Inclusion are more than words to us, they are our DNA. We aspire to advance our medical technology for the global diverse patients, customers, and communities we serve. We embrace the unique backgrounds, perspectives, and mindsets of our employees, and seek to enhance these qualities through our hiring and talent management strategies. Our employees are empowered to bring their full authentic selves to work and collaborate to build a more rewarding environment for all to work and thrive. With a career at Nonin, you can expect to work in an environment where diversity is celebrated, and curiosity is rewarded. By joining Nonin, you will improve lives around the world, including your own.

What you will do:

• Execute quality and Design Assurance (DA) activities to support all Nonin Medical product lines and business initiatives.
• Determine and define quality and DA requirements to stakeholders throughout the company with emphasis on business groups strategic objectives.
• Ensure company products and operations comply with applicable quality and regulatory standard requirements including FDA, EU MDR and ISO 13485 requirements.
• Perform execution of pre-market strategic quality and DA product development activities and provide guidance and support for related post-market quality activities in collaboration with post-market team counterparts.
• Direct and enable compliant, efficient and risk-based execution of quality and DA strategy and supporting processes including design control, product verification/qualification, translation of VoC/clinical use environment into design inputs, external standards compliance and control, design for reliability, and design history file process owner.
• Execute new product development quality strategies including identification of applicable standards, design verification testing and human factors engineering.
• Serve as risk management owner and utilize knowledge of electrical, software and usability standards.
• Provide recommendations for how to overcome quality barriers and resolve any conflicts.
• Conduct gap assessments for remediation plans for Product Technical files, reclassification, GSPR and updating standard operating procedures (SOPs).
• Position requires domestic travel up to 15% as needed and customary for the occupation.

Position Requirements:

• The position requires a Master’s degree or foreign equivalent degree in Life Sciences, Engineering, or a closely related field and at least 1 year (12 months) of experience in a quality or design assurance engineering position or closely related occupation in the life sciences industry;
• Or in lieu of a Master’s degree and 12 months of experience, a qualified candidate may have a Bachelor’s degree in Life Sciences, Engineering, or a closely related field and at least 2 years (24 months) of experience in a quality or design assurance engineering position or closely related occupation in the life sciences industry.
• The qualified candidate must also have at least 1 year (12 months) of experience with the following: (a) quality assurance, design assurance, and/or compliance outcomes to support the achievements of organizational business objectives, and (b) regulations in the areas of FDA design control, EU MDR/MDD, FDA QSR, and ISO 13485.
• All experience may be gained concurrently.

Explore the Benefits of being a Nonin Team Member.

• Financial Security:
• 401(k), Employer Match
• Annual Incentive and/or Profit-sharing Plans
• Tuition Reimbursement
• Health and Wellness:
• Medical, Dental & Vision
• Flexible Spending and Health Savings Accounts
• Telemedicine Options
• Mental Health and Fitness Offerings
• Flexibility:
• Hybrid work schedules
• Flexible Hours
• Paid Time Off + Personal Days
• Parental Leave
• Personal Protection:
• Disability Insurance
• Accident & Critical Illness Insurance
• Life Insurance
• Identify Theft
• Voluntary Benefits to help employees meet individual needs.

Nonin is an Equal Opportunity/Affirmative Action employer committed to creating a diverse workforce. We are committed to diversity and support the principles listed in Equal Employment Opportunity is the Law and we consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability, or veteran status, among other factors. To request a copy of our Affirmative Action policy, or if a disability prevents you from applying for a job online, call us at 1-800-356-8874 and ask for a human resources representative.

It is the policy of Nonin Medical that all offers of employment made shall be contingent upon successful completion of electronic background check(s). These checks will be job-related, consistent with business necessity, and conducted by our vendor pursuant to all applicable laws, rules, policies, and procedures of our candidates' specific locale.

Ready to embark on a thrilling journey with us? Apply now and be part of a team that's shaping the future of healthcare technology!