Senior Advanced Quality Engineer

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Tempe, AZ, 85280, US
Job details
Work flexibility: Hybrid or Onsite Req ID: R538333 Employee type: Full Time Job category: Engineering Travel: 10% Relocation: No

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Why join Stryker?

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We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Job description

Stryker is hiring a Senior Engineer, Advanced Quality for our Sustainability Solutions team supporting our reprocessing product line. You will be a key member of the new product development team ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast-paced environment with opportunities to win for yourself, the company, and patients around the world.  This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer.

Workplace Flexibility: Candidate must reside within a commutable distance to Tempe, AZ and is expected to be onsite 3+ days/week at the facility and is not eligible to be fully remote.

What you will do:

  • Represents Quality Assurance on New Product Development (NPD) cross-functional teams, collaborating with R&D, Regulatory Affairs, Advanced Operations, and Marketing to meet product development metrics.
  • Leads Risk Management activities, including creating and implementing Risk Management Files, identifying hazards, and ensuring compliance with corporate and divisional design control procedures.
  • Plans, designs, and implements inspection, testing, and evaluation methods to ensure product and production reliability, applying advanced statistical techniques for test sample size determinations.
  • Leads Design Reviews to ensure design and process robustness, compliance with applicable regulations (e.g., QSR, ISO 13485), and proper risk analysis for new medical devices.
  • Plans, performs, and reviews engineering risk analyses, test methods, and process improvements to enhance product quality and manufacturing efficiency.
  • Provides leadership in product development by guiding engineering principles, interpreting test data, and developing process and product protocols.
  • Mentors junior staff, leads departmental initiatives, and influences multiple teams to drive quality and regulatory compliance throughout the development process.
  • May interact with customers to address product quality concerns, provide training on quality assurance and GMP topics, and support continuous improvement initiatives.

What you will need:

Required:

  • Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering.
  • Minimum of 2+ years’ experience in an engineering role.
  • Experience in data collection, data analysis, and scientific method.

Preferred:

  • Experience with Quality Concepts such as Risk Management, CAPA, Audits, Statistics.
  • Previous medical device industry experience preferred 
  • Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.
  • Six Sigma Green Belt or ASQ CQE.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

Financial benefits include:Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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