Sr NPI Quality Assurance Eng I
Location: Eden Prairie
Posted on: April 5, 2021
Job Details Description Starkey Hearing Technologies is a
privately held, global hearing technology company headquartered in
Eden Prairie, Minnesota. Foundedin 1967, Starkey is known for its
innovative design, development and distribution of comprehensive
digital hearing systems. Starkey is the only American-owned
provider of hearing technologies. The company has more than 5000
employees globally, operates 26+ facilities and does business in
more than 100 markets worldwide. Starkeys product Livio AI was
named to TIMEs list of the 100 Best Inventions of 2019. We are
looking to add a Sr. NPI Quality (Design) Assurance Engineer to our
team that will be 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). This
role is a key partner with Research and Development, Regulatory,
Marketing, Customer Experience, and Manufacturing Engineering. This
position is responsible to provide a high standard or product
quality that conforms to the global standards and regulatory
requirements, while ensuring a primary focus on patient safety and
reliable product performance. This engineer will lead quality
assurance and compliance by applying Design Controls identified in
product risk management file throughout the product life cycle
(Advanced Development, Product Development, and Product
Manufacturing). Approach and Deployment Quality Assurance
- Own and drive deliverables related to NPI process: Design
Controls, Risk Management, Produce Performance, Quality and
Compliance; key partner in all department goals and
- Understand medical device risk management concepts and their
application to the product firmware/software
- Partner with Design Engineering on new product development.
Participate in design reviews, establish quality requirements, and
coordinate qualification testing.
- Communicate any project or process issues in a timely manner.
- Able to implement new operational tools and methods to improve
product quality and operational efficiency
- Skilled at driving awareness to issues and organizing teams to
address where appropriate.
- Partner with the cross functional development teams to ensure
the NPI process is adhered to. Escalate non-conformances as
- Support and mentor cross functional teams to ensure sound,
systematic problem-solving methodologies are utilized to
identifying, prioritizing, communicating, and resolving quality
issue through the product life cycle. Results Performance
- Reduction in warranty cost or complaints per product
- Complete work requests in a timely manner ( Qualifications
- At least a 4-year college degree (M.S. preferred) in
Engineering with a strong emphasis in Biomedical, Electrical, or
Mechanical Engineering or equivalent required Experience
- Minimum 7 years of design assurance or quality assurance
- Experience with Operations, Customer Service, Sales, and/or
Marketing business functions desired. Knowledge
- Knowledge of mechanical, electrical, or firmware engineering
- Product development lifecycle principles required.
- Knowledge and understanding of software design, architecture
and development is required
- Knowledge of ISO 13485/ISO 9000and ISO14971 required Skills &
- 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
- Enough judgment to make reasonable business decisions
concerning quality issues with regard for both economic and quality
aspects. #LI-LK1by Jobble
Keywords: Starkey, Eden Prairie , Sr NPI Quality Assurance Eng I, Engineering , Eden Prairie, Minnesota
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