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Senior Staff Quality Engineer in Kalamazoo, MI at Stryker Corporation

Date Posted: 4/2/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Kalamazoo, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    4/2/2019
  • Job ID:
    R414184

Job Description

Who we want

Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

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

What you will do

To ensure that Stryker remains a world leader in Med Tech, IMT is structured and positioned to address organizational opportunities related to innovation and R&D collaboration. The goal is to pursue strategic, game changing, high risk and high ROI market opportunities that likely span three plus years to commercialization. These opportunities will generally be innovative in technology, business model or both.

As a Senior Staff Quality Engineer in IMT you will be responsible for leading quality engineering efforts for new product development with a focus on electrical and software quality typically on Technology Blocks that will be shared across Stryker Divisions. You will be responsible for driving requirements management, reliability engineering, risk management, and design verification, while ensuring compliance to FDA Quality System Regulations and ISO 13485 (i.e. compliance to Stryker’s Quality Management System).  You will additionally provide consultation to product groups during the NPD / Software life cycle, and evaluate new products to the applicable business, compliance, and product specific requirements.  

  • Will provide day-to-day consultation for R&D and communicate the intent of how the Quality Management system is fulfilled
  • Will manage Corporate Wide Technology Block Process & corresponding traceability
  • Will be responsible for RISK management and the associated tangibles
  • Will determine Design Verification & Validation plans that follow statistically significant principles (i.e. sampling plans, confidence intervals, etc.)
  • Will conduct Design Verification testing (both hardware verification and software validation) on existing and new products to ensure design inputs are met.
  • Will coordinate Electromagnetic Interference (EMI) and Electromagnetic Compatibility (EMC) testing on existing and new products to ensure safety compliance (compliance to IEC60601-2).

What you need

  • Bachelor’s degree in electrical engineering, computer science, computer engineering or related technical discipline
  • 8 + years of experience minimum; 5 or more years of experience in Advanced Quality and R&D Engineering
  • Experience in a highly technical, new product development focused business unit

Work From Home: No

Travel Percentage: Up to 25%

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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