Sr. Design Assurance Engineer - Onsite

Starkey•Eden Prairie, MN

11d•Onsite

About The Position

Starkey is adding a Sr. Design Assurance Engineer I - Onsite to it's Quality team at it's 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). Is a key partner to Research and Development, Regulatory, Marketing, and Manufacturing Engineering. This position is responsible for providing 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. Founded in 1967 by Bill Austin, Starkey is known for our cutting-edge hearing health innovations, industry-leading research and development, and not being afraid to push the edge of what’s possible. We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide. Watch this video to see more of what sets Starkey apart. https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6

Requirements

4-year college degree in Engineering or another technical field required
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
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.

Nice To Haves

Six Sigma Blackbelt, Lean Systems, or other continuous improvement methodology experience desired.
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.

Responsibilities

Design Quality Assurance.
Partner with Design Engineering on new product development.
Participate in design reviews, establish quality requirements, and coordinate qualification testing.
Owns 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.
Develops 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