Senior Quality Engineer - Design Assurance NPD in Tempe, AZ at Stryker Corporation

Date Posted: 10/25/2020

Job Snapshot

Job Description

Who we want:

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

As a Senior Quality Engineer – Design Assurance NDP for Stryker 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.

  • Represents Quality Assurance on the New Product Development (NPD) cross-functional team (CFT). Interfaces among multiple departments and teams such as R&D, Regulatory Affairs, Advanced Operations, and Marketing to ensure specific product development metrics are met.
  • Creates and implements the Risk Management File for an NPD team.
  • Leads Risk Management activities for an NPD team, including identifying hazards and harms that may be associated with the medical device.
  • Leads Design Reviews for NPD teams to ensure design and process robustness and compliance to Corporate and Divisional design control procedures.
  • Leads the exercise of understanding the functional inputs and outputs of the medical device.
  • Plans, designs, and /or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment.
  • Analyzes reports and recommends corrective action.
  • Plans and develops process and product protocols and monitors progress.
  • Provides and/or reviews advanced statistical techniques for test sample size determinations.
  • Uses and/or reviews advanced statistical rationale to plan, analyze, and interpret engineering test data collected during new medical device testing.
  • Plans, leads, monitors, and/or controls progress of projects to ensure sound application of engineering principles are used, and design intent is being achieved.
  • Plans, selects, analyzes, designs, and/or improves manufacturing procedures and engineering systems for medical devices.
  • Plans and verifies that new engineering devices are technically sound and in compliance with FDA and other regulatory bodies.
  • Plans, performs, and reviews engineering risk analyses to manage technical difficulties encountered with new medical devices.
  • Interface with Suppliers of replacement components for new medical devices and ensure they meet the requirements of the Production Part Approval Process(PPAP) and Supplier Part Certification Process.
  • Plans and leads departmental initiatives
  • Demonstrates technical leadership as a departmental resource.
  • Provides leadership and mentoring to more junior staff.

What you need:

  • Bachelor's Degree in an engineering discipline – required
  • 2+ years’ medical device experience (or related engineering experience within a highly regulated industry) - required
  • Master’s Degree in Biomedical, Mechanical, Electrical or Chemical Engineering – preferred
  • Strong working knowledge of FDA/QSR, ISO 13485:2003, and/or ISO 14971 - preferred
  • Experience with quality engineering principles and quality tools/methods – preferred
  • Six Sigma Green Belt or ASQ CQE - preferred
  • Risk management tools experience (i.e. DFMEA, FMEA) – preferred
  • R&D and/or NPD experience - preferred

Work From Home: Not available

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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