Permanent position: Multi billion dollar medical device manufacturing company in Northern California is currently in search for a Sr Test Method Engineer. The This role will focus on test method development and validation to support the emerging market of Transcather Mitral Valve therapy. The Sr Test Method Engineer will work within the quality function on product development programs in the structural heart business unit. Sr Test Method Engineer must have a 4 Bachelors degree with a preference in Engineering, Science or similar discipline. Ideal candidate will have a minimum of 4 years industry experience. Responsibilities for the Test Engineer
Requirements for the Test Engineer
- Collaboration with cross-functional project team members as well as members of the QA extended team.
- Participates in the development of in vitro test methods
- Develops and leads test method and software validation strategies
- Compiles and analyzes performance reports and process control statistics
- Investigates and analyzes relevant variables potentially affecting product and processes.
- Determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data
- Tracking timelines and facilitating the required Design Quality Engineering deliverables; Guiding the successful completion of projects
- Bachelors Degree- Engineering, Science or similar discipline
- Minimum of four years experience within the medical development industry
- Knowledge of Six Sigma/DRM tools.
- Familiar with regulations: FDA 21 CFR Part 820, Part 211, Part 4, ISO 13485.
- Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints.
- Experience in a regulated industry
- Comprehensive compensation package which includes an industry leading salary, bonus, 401k plan, company provided benefits, paid holidays and vacation.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.