You can count on Nonin. Our vision is to improve people's lives by creating noninvasive medical devices people can count on. Nonin's culture is grounded in our mission, and we live by our cultural tenets of courage, ownership, and agility. The courage to challenge assumptions and take risks, the ownership to act with accountability, and the agility to constantly innovate and move with speed. It is these tenants that have made Nonin the technology leader for over 30 years. As a privately owned company, each of us operate with a shared commitment and act as family versus colleagues. You are not one among many, but an important part of our success with the ability to learn, grow and impact all aspects of the business. Recognizing that each one of us is unique, we build flexibility and choice into our philosophies. We embrace the unique backgrounds, perspectives, and mindsets of our employees and collaborate to build a more rewarding environment for all to work, thrive and have a little fun. So, if you are looking for a smaller company to spread your wings while making big company impacts, join Nonin today... Together we will improve lives around the world, including your own.
Are you ready to take your career to new heights?
Position Overview
The Senior Design Assurance (DA) Engineer executes quality and DA activities to support all Nonin Medical product lines and business initiatives. Additionally, this position provides DA leadership, strategy and support for Nonin business groups and associated product development efforts. Determine and define quality and DA requirements to stakeholders throughout the company.
Essential Job Functions

• Lead DA activities for Nonin business groups in worldwide markets; ensure company products and operations are in compliance with applicable quality and regulatory standard requirements including FDA, EU MDR and ISO 13485, and internal Nonin processes and quality requirements.
• Lead and manage execution of pre-market strategic quality and DA product development activities.
• Provide guidance and support for related post-market quality activities in collaboration with post-market team counterparts.
• Responsible for developing Design and Development Plans, Risk Management Files, and Device Master Records.
• Responsible for product assessment and determining what features need to be tested to ensure process capability.
• Execute pre-validation assessments, including selection of materials/equipment/test methodology, design reviews, and decisions on design changes to meet revised specifications.
• 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.
• Serve as subject matter expert on domestic and international standards and regulations with the ability to conduct gap assessments between revisions.
• Serve as business group DA subject matter expert and collaborate closely with Nonin cross-functional stakeholders to achieve enterprise business objectives.
• Serve as liaison with third party test labs and manage external testing and certifications for device control requirements such as Biocompatibility, electrical safety.
• Serve as liaison with calibration labs and manage metrology database.
• Drives new product development quality strategies including identification of applicable standards, design verification testing and human factors engineering.
• Serves as the risk management owner and has working knowledge of electrical, software and usability standards including IEC 60601-1, 80601-2-61, 62304, 60601-1-6, ISO 62366, and 10993.
• Ensure compliance of customer requirements, risk management, quality and design control requirements in design and development projects for successful transfer of the design to manufacturing.
• Support integration of post market surveillance processes into Design Controls and Sustaining initiatives through DVT testing and change management.
• Provide recommendations for how to overcome quality barriers and resolve any conflicts within teams as to the need for and importance of quality requirements.
• Facilitate organizational cohesiveness with the Nonin quality and DA philosophy and improve quality and compliance position and consistency of the Nonin businesses.

Required Education & Experience:

• Bachelor's Degree in a scientific, engineering or related technical discipline.
• 4-7 years of experience within the quality or design assurance discipline in the life sciences industry.

Required Knowledge, Skills & Abilities:

• Demonstrated history of successful quality, design assurance and/or compliance outcomes to support achievement of organizational business objectives.
• Knowledge of applicable regulations in the areas of FDA design control, EU MDR/MDD, FDA QSR, ISO 13485, and ISO 14971.
• MDR expertise, with participation in a successful MDR certification project.
• Strong written and verbal communication skills, especially when dealing with regulatory agencies or certification bodies.
• Ability to explain and resolve differences in interpretation of standards, regulations and quality/compliance requirements.

Preferred Qualifications:

• Advanced degree and/or professional certification in quality/regulatory/compliance.

Physical Requirements:

• Sit, and/or stand 8 hrs/day
• Ability to travel up to 15% as needed

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:
• 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!