Quality Assurance Design Engineer II - NPI

About the role

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 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.

Responsibilities

• Participate in design reviews, establish quality requirements, and coordinate qualification testing.
• Own and drive deliverables related to the NPI process: Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Proactively partner with Design and Manufacturing team members to identify and implement solutions to yield higher reliability and quality products.
• 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.

Requirements

• Education: 4 years college degree in Engineering with an emphasis in Mechanical or Electrical Engineering required.
• Experience: 4 years of experience in Quality Engineering, Design Engineering, or Manufacturing Engineering required.
• Knowledge: Electrical engineering desirable. Metallurgy, plastics, and chemistry desirable. Process validation, developing inspection plans and process control plans using sampling plans and statistical methods and basic measurement techniques desired. Medical device manufacturing a plus.

Skills & Abilities

• Excellent 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).
• Sufficient judgment to make reasonable business decisions concerning quality issues with regard for both economic and quality aspects.

Equipment Operation

• Measurescope/Toolmakers microscope
• Microsectioning equipment
• Computer and associated spreadsheet/word processing software
• Microscope
• Environmental Chambers
• acoustic test equipment.

Pay and Other Compensation

The target rate for this position is between $78,540 to $98,569/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 following benefits for this position, subject to applicable eligibility requirements, include medical, dental and vision insurance, 401(k) retirement plan with company match, company-paid life and 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 and tuition reimbursement. This position is eligible for a bonus based upon performance results. There is no guarantee of payout.