Quality Assurance Design Engineer II - NPI
About The Position
Starkey is hiring a NPI Design Quality Assurance Engineer II at its global headquarters in Eden Prairie, Minnesota. This position ensures product quality and compliance by leading the application of Design Controls and Risk Management throughout the product life cycle, including Advanced Development, Product Development, and Product Manufacturing. The role supports high standards of product quality in accordance with global standards and regulatory requirements, with a primary focus on patient safety and reliable product performance. The engineer partners with Design Engineering and Manufacturing on new product development, supports design reviews, establishes quality requirements, coordinates qualification testing, and owns NPI-related deliverables involving Design Controls, Risk Management, Product Performance, Quality, and Compliance. The role also develops project quality plans and helps improve organizational practices and cross-functional problem-solving throughout the product life cycle.
Requirements
- Four-year college degree in Engineering, with an emphasis in Mechanical or Electrical Engineering.
- At least 4 years of experience in Quality Engineering, Design Engineering, or Manufacturing Engineering.
- Knowledge of mechanical engineering or electrical engineering.
- Excellent analytical and problem-solving skills.
- Excellent people skills.
- Strong collaboration skills.
- Strong written and oral communication skills, including the ability to communicate clearly, concisely, accurately, persuasively, and appropriately for the audience.
- Sound judgment in making business decisions concerning quality issues while considering both economic and quality aspects.
Nice To Haves
- Electrical engineering knowledge is desirable.
- Knowledge of metallurgy, plastics, and chemistry.
- Knowledge of process validation, development of inspection and process control plans using sampling plans and statistical methods, and basic measurement techniques.
- Experience in medical device manufacturing.
Responsibilities
- Partner with Design Engineering on new product development.
- Participate in design reviews, establish quality requirements, and coordinate qualification testing.
- Own and drive NPI process deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
- Partner proactively with Design and Manufacturing teams to identify and implement solutions that improve product reliability and quality.
- Develop project quality plans at an appropriate level of due diligence and deliver them on time.
- Identify and implement procedural improvements to establish a lasting culture of quality.
- Support and mentor cross-functional teams in using systematic problem-solving methods to identify, prioritize, communicate, and resolve quality issues throughout the product life cycle.
- Adapt productively to change and perform other essential duties as assigned.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan with company match
- Company-paid life insurance
- Short-term disability insurance
- Long-term disability insurance
- Employee assistance plan
- Hearing aid benefits
- Paid Time Off
- Paid holidays
- Paid floating holidays
- Paid volunteer service day
- Paid paternity leave
- Paid maternity leave
- Tuition reimbursement
- Performance-based bonus eligibility
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
