NPI Design Quality Engineer II

Starkey Hearing Technologies; Eden Prairie (MN); On-site; USD 79,000 - 99,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401(k) retirement plan with company | 

Company-paid life and short-term(dis)

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

Job summary

Starkey Hearing Technologies in Eden Prairie, MN seeks an NPI Design Quality Assurance Engineer II with 4+ years in manufacturing and an engineering degree. You will lead design controls, risk management, and qualification testing across the product life cycle to ensure patient safety and reliable performance.

Join a global leader in hearing technologies, with a focus on quality, regulatory compliance, and collaboration with Design and Manufacturing teams to deliver high-quality medical devices.

Qualifications

• 4 years college degree in Engineering with an emphasis in Mechanical or Electrical Engineering.
• 4 years of experience in Quality Engineering, Design Engineering, or Manufacturing Engineering.
• Knowledge of mechanical or electrical engineering; metallurgical, plastics, and chemistry desirable.
• Process validation, inspection plans and process control plans using sampling plans and statistical methods.
• Medical device manufacturing a plus.

Responsibilities

• Partner with Design Engineering on new product development; participate in design reviews, establish quality requirements, and coordinate qualification testing.
• Owns and drive deliverables related to the NPI process: Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Proactively partner with Design and Manufacturing teams to identify and implement solutions to yield higher reliability and quality.
• Develops project quality plans to an appropriate level of due diligence and deliver on time.
• Identify and implement procedural improvements to establish a lasting culture of quality.
• 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.
• React to change productively and handle other essential duties as assigned.

Skills

Quality Engineering

Design Engineering

Manufacturing Engineering

Mechanical Engineering

Electrical Engineering

Education

Bachelor's degree in Engineering (Mechanical or Electrical)

Tools

Measuring instruments (Measurescope)

Toolmakers microscope

Microsectioning equipment

Computer with spreadsheet/word processing

Microscope

Environmental chambers

Acoustic test equipment

Job description

Starkey Hearing Technologies in Eden Prairie, MN seeks an NPI Design Quality Assurance Engineer II with 4+ years in manufacturing and an engineering degree. You will lead design controls, risk management, and qualification testing across the product life cycle to ensure patient safety and reliable performance.

Join a global leader in hearing technologies, with a focus on quality, regulatory compliance, and collaboration with Design and Manufacturing teams to deliver high-quality medical devices.