A leading Medical Device company are actively seeking a motivated candidate to fill their Sr. Software Quality Engineer opportunity. This is an initial 6-month contract role with opportunity to extend/ convert to FTE. This role is based out of Irvine, CA and the salary ranges between $53-58/hour depending on experience.
- B.Sc. in Engineering with 5+ years of experience.
- Previous experience with software verification and validation activities in a medical device industry.
- Experience with investigating complex product/ non-product software quality and compliance issues (e.g., software deviations/failures) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
- Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects / systems / test equipment in partnership with cross-functional teams; provide recommendations for improvements.
- Develop complex software documentation (e.g. Protocols, Reports, Hazard Analysis) for product or non-product software validation deliverables utilizing engineering knowledge.
- Collaborate with stakeholders on the Code Review process for product software or custom manufacturing test equipment.