Manager Fmea Jobs (NOW HIRING)

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 40 years. As a privately owned, small company, 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. 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. 

The benefits of working at Nonin include: 

• Financial Security: 401(k) Employer Match, Annual Incentive and/or Profit-sharing Plans
• Health and Wellness: Medical, Dental & Vision, and voluntary benefit offerings
• Flexibility: Paid Time Off + Personal Days, Paid Parental Leave

Essential Job Functions:

• Serve as the technical lead and system architect for complex development programs by defining and evaluating system-level designs, trade-offs, and engineering approaches
• Provide technical direction, work guidance, and development to all electrical engineers while fostering a culture of continuous improvement
• Lead design reviews and ensure alignment with performance, cost, safety, and regulatory requirements
• Mentor and guide engineers and technical staff across the organization
• Promote best practices, design consistency, and engineering excellence

• Drive full product lifecycle development from concept to production
• Lead development of electrical hardware and integrated subsystems
• Identify risks early and implement mitigation strategies (e.g., FMEA, testing, modeling)
• Contribute across multiple concurrent programs of high complexity

• Develop and review key technical documentation including design specifications, verification and validation protocols, DOE, FMEA, and statistical analyses
• Ensure compliance with FDA Design Controls, ISO 13485, and applicable global regulatory standards
• Support design transfer, manufacturing readiness, and post-market improvements

• Contributes to Annual Operating Plan (AOP) development, including project planning, resource needs, and technical roadmaps
• Supports execution against AOP commitments, aligning engineering deliverables with business priorities
• Partners with leadership and cross-functional teams to advance technology strategy and innovation priorities
• Identifies opportunities to improve product performance, cost, and platform scalability

Minimum Qualifications: 

• Bachelor’s degree in Electrical Engineering or related field
• 7+ years of progressive engineering experience within the medical device or similarly regulated industry, or equivalent combination of education and experience

 Required Knowledge, Skills & Abilities:

• Proven track record leading complex product development efforts and problem solving
• Strong experience in electrical hardware development including microprocessor-based systems. board-level design, signal processing and system integration
• Proven ability to deliver products in regulated environments and experience with FDA design controls and ISO 13485 or equivalent quality systems.
• Experience with computer-based simulation and analysis tools
• Design verification, validation, and analysis methodologies
• Risk management (FMEA), DOE, and statistical analysis
• Excellent leadership, communication, and interpersonal skills

Preferred Qualifications: 

• Master’s or advanced degree in relevant technical discipline
• Experience with microprocessor-controlled medical devices
• Experience supporting multiple concurrent development programs
• Background in platform or system-level architecture
• People leadership experience

Physical Requirements: 

• Ability to sit, and/or stand for 8 hrs/day.

Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Disabled/Veteran. 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.