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Principal Quality Engineer

Company: Starkey Hearing Technologies
Location: eden prairie
Posted on: May 3, 2021

Job Description:

Starkey Hearing Technologies is a privately held, global hearing technology company headquartered in Eden Prairie, Minnesota. Founded by Bill Austin in 1967, Starkey is known for its innovative design, development and distribution of comprehensive digital hearing systems. The company has more than 5,000 employees, operates 24 facilities and does business in more than 100 markets worldwide.We are looking to add a Principal 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 DeploymentQuality AssuranceOwn 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/softwarePartner 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 ImprovementAble to implement new operational tools and methods to improve product quality and operational efficiencySkilled 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 identifiedSupport 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 MeasuresReduction in warranty cost or complaints per product segmentComplete work requests in a timely manner ( QualificationsEducationAt least a 4-year college degree (M.S. preferred) in Engineering with a strong emphasis in Biomedical, Electrical, or Mechanical Engineering or equivalent requiredExperienceMinimum 15 years of design assurance or quality assurance required Experience with Operations, Customer Service, Sales, and/or Marketing business functions desired.KnowledgeProficient knowledge in Design Controls (21 CFR 820), ISO 13485, and ISO14971Proficient knowledge of risk-based development tools: Patient Hazard Analysis, DFMEA, PFMEA, Fault Tree AnalysisProficient knowledge of process validation, developing inspection plans, control plan development, and using statistical methodologiesKnowledge of medical device development requiredKnowledge of electrical engineering, mechanical engineering, and materials science desiredSkills & AbilitiesExcellent 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-LK1 Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Starkey Hearing Technologies, Eden Prairie , Principal Quality Engineer, Other , eden prairie, Minnesota

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