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. The position is responsible for ensuring product quality and compliance throughout the product life cycle, including Advanced Development, Product Development, and Product Manufacturing. It leads the application of Design Controls and Risk Management to ensure products meet global standards and regulatory requirements, with a focus on patient safety and reliable performance. The engineer partners with Design Engineering on new product development, participates in design reviews, establishes quality requirements, coordinates qualification testing, and owns NPI deliverables related to Design Controls, Risk Management, product performance, quality, and compliance. The role also works with Design and Manufacturing teams to improve product reliability and quality, develops project quality plans, and promotes systematic problem-solving and continuous improvement across cross-functional teams. Starkey is a hearing technology manufacturer and distributor founded in 1967. It is headquartered in Eden Prairie, Minnesota, has more than 5,000 employees across 29 facilities, and does business in more than 100 markets worldwide.
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 and strong collaboration skills.
- Strong written and oral communication skills, including the ability to communicate in a timely, clear, concise, accurate, conclusive, influential, and audience-appropriate manner.
- Sound judgment to make reasonable business decisions concerning quality issues while considering economic and quality aspects.
Nice To Haves
- Electrical engineering knowledge is desirable.
- Knowledge of metallurgy, plastics, and chemistry is desirable.
- Knowledge of process validation, developing inspection plans and process control plans using sampling plans and statistical methods, and basic measurement techniques is desired.
- Medical device manufacturing experience is a plus.
Responsibilities
- Partner with Design Engineering on new product development.
- Participate in design reviews, establish quality requirements, and coordinate qualification testing.
- Own and drive NPI deliverables related to Design Controls, Risk Management, product performance, quality, and compliance.
- Partner with Design and Manufacturing team members to identify and implement solutions that improve product reliability and quality.
- Develop project quality plans with 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.
- React productively to change and handle 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 and maternity leave
- Tuition reimbursement
- Performance-based bonus eligibility; payout is not guaranteed
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
