Job Description
Assists in the transfer of Design History files for multiple products to Stryker DHF
Assists in the collection and storage of Design History file documents that need to be transferred
Stryker requirements and identifies gaps
Undertakes assessment of Design Controls Documentation relating to Software aspects of products against Stryker requirements and identifies gaps
Undertakes review of Software code for each of the products against Stryker software and coding procedures and identifies gaps.
Evaluates Software Architecture and Requirements documents for content and detail, identifying gaps.
Software unit description and documentation
Review of software security/Cybersecurity of Devices
Lead generation of any software related test data, retrospective documents etc to satisfy Design Controls requirements
Supports Quality, Regulatory, Marketing activities related to product risk and claims – identifying and executing engineering activities/testing to generate evidence.
Reviews verification test protocols for each of the tests undertaken for verification and validation.
Review software aspects of usability engineering file identifying any gaps
Assists in the development of test protocols for identified gaps in Verification, Validation or Marketing Claims. Manages execution and administration of product testing.
Collaborate with wider integration team through supporting R&D requirements needed for parallel workstreams.
In conjunction with the tech lead, organize technical reviews when needed. Document and file tech review content and meeting records
Work closely with Project Management and technical leads communicating progress updates, Due Dates, Milestones, Delays, challenges and wins on a regular basis
Top Skills' Details
Software Engineer
Test Protocols
DHF Review
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
