Sr NPI Design Quality Assurance Engineer

Sr NPI Design Quality Assurance Engineer I

Job Category
:
Engineers

Requisition Number
: SRNPI
007368

Posted
:
May 19, 2026

Employment Type
:
Full-Time

Work Location
:
On-site

Locations:
Eden Prairie, MN 55344, USA

Starkey is hiring a Sr NPI Design Quality Assurance Engineer I at its global headquarters in Eden Prairie, MN. This position is responsible for ensuring product quality and compliance through leading the application of Design Controls and Risk management through the entire product life cycle (Advanced Development, Product Development, and Product Manufacturing). It is a key partner to Research and Development, Regulatory, Marketing, and Manufacturing Engineering.

This position provides a high standard of product quality that conforms to global standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance.

Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better.

Watch this video to see more of what sets Starkey apart:

• Partner with Design Engineering on new product development. Participate in design reviews, establish quality requirements, and coordinate qualification.
• Own and drive deliverables related to the NPI process:
  Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives.
• Technically review product system requirements and identify critical to safety and quality requirements. Communicate any project or process issues in a timely manner.
• Develop project quality plans to an appropriate level of due diligence and deliver on time; ensure project quality plans are followed through the design and product launch phases.
• Qualify new components, final assemblies, and custom manufacturing processes.
• Ensure product qualifications are completed on time.

• Partner with the NPI department to ensure the NPI process is followed for critical projects.
• Support and mentor cross functional teams to ensure sound, systematic problem-solving methodologies are utilized to identify, prioritize, communicate, and resolve quality issues through the product life cycle.
• Perform other duties/responsibilities as assigned.

• 4-year college degree in Engineering or another technical field.
• Six Sigma Blackbelt, Lean Systems, or other continuous improvement methodology experience desired.

• Minimum 7 years of experience in medical device Quality Engineering.

• Knowledge and experience with ISO 13485:2016 and ISO 14971:2019 required.
• Knowledge of medical device design or manufacturing required.
• Knowledge of process validation, developing inspection plans and process control plans using sampling plans and statistical methods and basic measurement techniques desired.
• Knowledge of medical device manufacturing desired.
• Knowledge of mechanical shock, vibration, and environmental testing desired.
• Knowledge of acoustic engineering desired.
• Knowledge of DOE and SPC techniques desired.
• Knowledge of Quality Plans desired.
• Knowledge of new product development systems desired.
• Knowledge of quality systems desired.
• Excellent analytical and problem-solving skills required.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience).
• Sufficient judgment to make reasonable business decisions concerning quality issues with regard to both economic and quality aspects.

• Standard office conditions.
• Requires up to 10% travel.

• Measure scope/Toolmakers microscope, Microsectioning equipment, computer and associated spreadsheet/word processing software, Environmental Chambers, acoustic test equipment.

The target rate for this position is between $93,940/year to $123,665/year. Factors which…