Sr. Advanced Quality Engineer - Software - 26322BR - EN in Kalamazoo, MI at Stryker Corporation

Date Posted: 1/30/2018

Job Snapshot

Job Description

At Stryker, we are driven to make healthcare better through our core values of integrity, accountability, people and performance. We are committed to designing, developing and delivering a premium product for our customers. The Senior Advanced Quality Engineer helps Stryker achieve this goal by integrating quality into the design and process during New Product Development (NPD).
  • Developing software according to SDLC with primary points of focus on planning, defining requirements, testing, and deployment.
  • Co-develops software solutions by conducting research to understand user needs, data usage, systems flow, work processes, problem areas and bug reporting, and driving good code practices.
  • Provide engineering input to impact the design, coding and debugging of software in various coding languages including SOUP software.
  • Performs software analysis, code analysis, requirements analysis, software review, identification of code metrics, system risk analysis, and software reliability analysis
  • Performs Software build, Maintenance, and change control. Maintains software configuration management in Perforce.
  • Lead project team through Software Defect Management in all phases of development.
  • Collaboration with other engineering disciplines, such as electrical, mechanical and industrial design, to ensure that embedded software will accomplish design goals for a particular product or system.
  • Help guide New Product Development teams through our quality system to ensure software is developed in compliance to internal procedures as well as the requirements of the FDA, ISO, and other regulatory bodies, which may include: FDA, ISO 13485, ISO14971, FDA 21 CFR Part 11, FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001, ANSI AAMI IEC 62304:2006 (formerly AAMI SW68), AAMI TIR32, AAMI TIR36, AAMI SW87, AAMI TIR45, IEC 80001-1, BS EN 60601-1-2: 2007, CEI IEC 60812, IEC TR 80002-1, DS DS/EN 61508-6, ISO 60601-3rd Edition and FDA General Principles of Software Validation GPSV requirements
  • Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products.
  • Perform software risk analysis and develop risk control measures and test strategies to ensure safe and reliable products are launched to Stryker’s high quality standards.
  • May have involvement in continuous improvement projects for the organization
  • Involvement in training others
  • Communicates effectively with team and management to drive project efficiency and status of progress with a focus on solutions.
  • Knows and applies fundamental and some advanced concepts, practices and procedures of practical field of specialization.

Job Requirements

  • Bachelor's or Master’s degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, or related field or equivalent discipline is required
  • Regulated industry experience such as Medical, Aerospace, Defense, Communication, and/or automotive embedded software control experience is a plus.
  • 2-3 years of experience in an equivalent position within an R&D environment is preferred
  • 2-3 years of experience in software test or quality is a distinct advantage
  • ISTQB or ASQ CSQE or equivalent experience and certification is desirable