Sr NPI Quality Assurance Eng II

Starkey is adding a Sr NPI Quality Assurance Engineer II at it's global headquarters in Eden Prairie, MN. Are you looking to make an impact and help an organization grow? This position is 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 to Research and Development, Regulatory, Marketing, and Manufacturing Engineering. This position is responsible to provide a high standard of product quality that conforms to global standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance.

Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for our cutting-edge hearing health innovations, industry-leading research and development, and not being afraid to push the edge of what’s possible. We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide.

Watch this video to see more of what sets Starkey apart.

https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6

This position is 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 to Research and Development, Regulatory, Marketing, and Manufacturing Engineering. This position is responsible to provide a high standard of product quality that conforms to global standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance.

JOB RESPONSIBILITIES 

Design Quality Assurance
o Partner with Design Engineering on new product development. Participate in design reviews, establish quality requirements, and coordinate qualification testing.
o Owns and drive deliverables related to the NPI process: Design Controls, Risk Management, Product Performance, Quality, and Compliance; key partner in all department goals and objectives
o Technically review product system requirements and identify critical to safety and quality requirements.
o Communicate any project or process issues in a timely manner.
o Develops project quality plans to an appropriate level of due diligence and deliver on time.
o Ensure project quality plans are followed through the design and product launch phases
o Qualify new components, final assemblies and custom manufacturing processes.
o Ensure product qualifications are completed on-time

Organizational Improvement 
o Partner with the NPI department to ensure the NPI process is followed for critical projects.
o Support and mentor department team members in Quality Assurance and Risk Management
o 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. 
Other duties/responsibilities as assigned. 

JOB REQUIREMENTS
Education
o 4 years college degree in Engineering or other technical field required
o Six Sigma Blackbelt
o Lean Systems, or other continuous improvement methodology experience certification desired.

Experience
o Minimum 10 years of experience in medical device Quality Engineering required. 
• Proficient knowledge and experience with ISO 13485:2016 and ISO 14971: 2019 required
• Knowledge of medical device design or manufacturing required
• Knowledge of IEC 62304 desired
• Knowledge of Process validation, developing inspection plans and process control plans using sampling plans and statistical methods and basic measurement techniques desired.
• Knowledge of quality systems desired.
• Knowledge of new product development systems desired.
• Knowledge of mechanical shock, vibration, and environmental testing desired.
• Knowledge of acoustic engineering desired.
• Knowledge of DOE and SPC techniques desired.
• Knowledge of Quality Plans desired
• Knowledge of new product development systems desired.

Competencies, Skills & Abilities 
• Excellent people skills required.
• Strong collaboration skills required.
• Excellent analytical and problem-solving skills required.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience).
• Sufficient judgment to make reasonable business decisions concerning quality issues with regard for both economic and quality aspects.

Work Context 
Equipment Operation 
• Measurescope, toolmakers microscope, microsectioning equipment, computer and associated spreadsheet/word processing software, microscope, environmental chambers and acoustic test equipment

Salary and Other Compensation: 
The target rate for this position is between $114,000 to $152,000 year.  Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.  

Benefits: 
The Company offers the following benefits for this position, subject to applicable eligibility requirements, include medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, short-term disability insurance, long-term disability insurance, employee assistance program, hearing aid benefits, PTO, 6 paid holidays annually, 2 floater days annually, 1 volunteer service day annually, paid paternity leave, and tuition reimbursement.

This position is eligible for a bonus based upon performance results. There is no guarantee of payout.

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Salary : $114,000 - $152,000