Quality Engineer - Electrical / Software

 •  Stryker Portage, MI

Medical Equipment

Salary depends on experience
Posted on 11/30/17
Portage, MI
Medical Equipment
Salary depends on experience
Posted on 11/30/17

23946BR

Are you an Electrical or Software engineering professional looking for a new Quality Career?

An Advanced Quality Engineer at Stryker plays a key role in the development of great new products that aim to make healthcare better. Stryker is a brand that stands for quality and we take pride in proactively building quality into our products from the very early concepts. The Advanced Quality Engineer is responsible for understanding the needs of the user, identifying potential failure modes and risks, leading the risk management process and appropriately mitigating risks through design and process controls, leading formative and summative usability studies and design validation activities. This is a dynamic role, with responsibilities that evolve throughout the development cycle. See below for a summary of key responsibilities:

Concept Development

  • Lead Quality Report development, analyzing field data of relevant predicate and competitive products with the intent of driving Design Inputs to mitigate issues
  • Lead User Need, acceptance criteria, and justification definition
  • Collaborate with R&D on defining complete, non-ambiguous, non-conflicting and verifiable Design Inputs, acceptance criteria, and justification of User Need coverage

Planning

  • Lead completion of functional analysis, hazard & hazardous situation identification
  • Collaborate with R&D to ensure Design Inputs are in place to mitigate hazards
  • Collaborate with R&D and Test Engineering in gaining confidence in the system’s ability to function according to performance design inputs via developmental testing and inspection
  • Collaborate with R&D on defining design outputs necessary to satisfy all design inputs
  • Lead Usage Category and Threshold calculations, identification of harms, severity & probability of occurrence of harms, causes of hazards, risk control measures, and projected overall residual risk
  • Collaborate with R&D on aligning Risk File with DFMEA
  • Lead Formative Usability studies to gain confidence in use-error risk control measure effectiveness

Development

  • Collaborate on refinement of engineering drawing specifications
  • Collaborate on vendor & integrated manufacturing process development, and plan for controlling process failure modes identified in PFMEA
  • Collaborate on initiation of inspection development and gage plan development
  • Lead implementation of additional risk control measures as necessary
  • Manage and track all software issues
  • Participate in software requirement specification and software design document reviews, and code reviews
  • Conduct software quality assurance plan audits to verify development practices conform toprocedures
  • Review software configuration management to verify its practices conform to procedures
  • Create and maintain software traceability matrix to track all requirements to closure
  • Develop and maintain black box test scripts
  • Lead identification of Critical Quality Attributes (including non-safety) on engineering drawing specifications
  • Lead Formative Usability studies
  • Lead feedback activities with customers to gain confidence in system’s satisfaction of user needs
  • Lead confirmation of implementation of risk control measures
  • Lead release of Final Design Validation protocols
  • Lead closure of inspection development activities with Advanced Ops, AQT, and vendors
  • Lead closure of incoming inspection plans (i.e. “gage plans”)
  • Lead component qualification (PPAP) activities;
  • Lead Production Equivalency Report

Verification and Validation

  • Lead confirmation of verification of effective risk control measures via Design Verification activities
  • Lead Design Validation of all user needs with customers
  • Lead confirmation of validation of effective use-error risk control measures via Summative Usability study
  • Complete Risk File, capturing verification of implementation (if any updates) & effectiveness of riskcontrol measures, risk/benefit analysis, and final Overall Residual Risk
  • Lead presentation to Risk Management Board to demonstrate verification of implementation and effectiveness of risk control measures, and acceptable overall residual risk

Job Requirements

  • Bachelors Degree in engineering
  • GPA of 3.0 or higher, strongly preferred
  • Achieved a limited (learning) level of industry knowledge
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.)
  • Must possess excellent oral and written communication skills
  • Ability to solve problems in a high stress situation
  • Possess attention to detail
  • Eagerness to assist internal and external customers
  • Manage projects in a timely manner
  • Ability to conduct and document technical investigation
  • The following experiences/skill sets are highly desirable:
    • ISO 13485 and ISO 14971
    • Industrial statistical techniques
    • Development and implementation of design and process controls
    • GD&T

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