Sr. Quality Engineer - Electrical in Kalamazoo, MI at Stryker Corporation

Date Posted: 8/26/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Kalamazoo, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/26/2018
  • Job ID:
    25649BR

Job Description

Who we want
 
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision. 
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.


What you will do

  • Execute quality assurance engineering work and provide input towards quality throughout the New Product Development for design quality and process quality.
  • Lead Human Factor’s engineering and design for good usability during development of the product.
  • Sound technical competence to ensure the delivery of robust designs, products, and processes.
  • Collaborate for process validation programs within New Product Development.
  • Collaborate with design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
  • Collaborate with manufacturing for process development and design for manufacturability, specifically for electrical subsystems and PCBAs.
  • Active participation of all activities during product launch, including driving non-conformances to resolution.
  • Lead risk analysis and develop mitigation strategies.
  • Execute to Stryker’s Quality System for New Product Development and guide teams through the quality system to ensure products are developed in compliance to their procedures and the requirements of the FDA, ISO, and other regulatory bodies.
  • Possibly act as a trainer for quality assurance topics, e.g. statistics, process validation and equipment qualification, DOEs, etc.
  • Will act as subject matter expert (SME), educating the NPD team to drive quality upfront in New Product Development.
  • Execute supplier development activities surrounding the Production Part Approval Process (PPAP.)
  • Create and update new/existing product development procedures for final verification of product.

What you will need

  • Bachelor of Science degree (B.S.) in Electrical Engineering or Engineering related discipline    
  • 3+ years of experience in an Engineering/Manufacturing environment or in a Quality Engineering role in a regulated environment
  • Experience with medical device development and manufacturing
  • Working knowledge of FDA, ISO, and other regulations and standards, e.g. ISO 13485, ISO 62366, and IEC 60601
  • Working knowledge of Risk Analysis, GD&T, SPC, Root Cause Analysis, Statistics and practical applications.
  • Process validation experience; preferred knowledge of GHTF approach to validation
  • ASQ Certifications (CQE, CRE, CQM, CSSBB)
  • Proficiency to understand and improve electrical designs and PCBA manufacturing processes

Work From Home: No

Travel Percentage: None

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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