Sr. Design Assurance Engineer - Onsite

Starkey is adding a Sr. Design Assurance Engineer I – Onsite to its Quality team at its global headquarters in Eden Prairie, MN. If you have 7+ years in medical device as a Quality Engineer this may be your next opportunity. 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. The role provides a high standard of product quality that conforms to global standards and regulatory requirements while prioritizing 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 focus on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for its cutting‑edge hearing health innovations, industry‑leading research and development, and willingness to push the edge of possibility.

We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities worldwide, and do business in more than 100 markets worldwide.

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 testing.
• Owns and drives 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 required.
• Six Sigma Blackbelt, Lean Systems, or other continuous improvement methodology experience desired.

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

• 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 new product development systems is desired.
• Knowledge of mechanical shock, vibration, and environmental testing is desired.
• Knowledge of acoustic engineering is desired.
• Knowledge of DOE and SPC techniques desired.
• Knowledge of Quality Plans desired.
• Knowledge of new product development systems is desired.
• Knowledge of quality systems desired.

• Excellent analytical and problem‑solving skills required.
• Excellent people skills required.
• Strong collaboration 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…