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Sr NPI Quality Assurance Eng I

Company: Starkey
Location: Eden Prairie
Posted on: April 5, 2021

Job Description:

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 objectives.
  • 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. Organizational Improvement
  • 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 identified
  • 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 Measures
  • Reduction in warranty cost or complaints per product segment
  • Complete work requests in a timely manner ( Qualifications Education
  • 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 required
  • Experience with Operations, Customer Service, Sales, and/or Marketing business functions desired. Knowledge
  • Knowledge of mechanical, electrical, or firmware engineering desired
  • 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 & Abilities
  • 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).
  • 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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