Job Type
Job Details
Stryker is hiring a Senior Biocompatibility Specialist to support our Joint Replacement division in Mahwah, NJ who will be performing biocompatibility assessments to determine product safety of the entire product portfolio.
Workplace Flexibility: Hybrid: Candidate must reside within a commutable
distance to Mahwah, NJ but is expected to be onsite at the facility 3+ days/week.
Who we want:
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Self-directed initiators. People who take ownership of their work, results-oriented, and need no prompting to drive productivity, change, and outcomes.
Team-players. People who can collaborate globally and thrive when developing lasting interpersonal relationships.
What you will do:
Support new product development and/or changes to medical devices currently on the market for biocompatibility/toxicology.
Support biocompatibility toxicological assessments, produce test data, and present results to cross-functional team.
Contribute to departmental initiatives.
Write technical and scientific documentation.
Support cross functional teams including (RA, AO, Ops) to ensure business unit project timelines are met.
Engage with team by supporting the development, maintenance, and improvements of the policies and procedures related to biocompatibility.
Participate in root cause analysis, problem solving, and out-of-specification investigations.
Contribute to validation & verification activities (i.e. product adoptions, testing plans, etc.).
What you need:
Bachelor degree or higher in a Science with a focus in Chemistry/Biochemistry/Toxicology or related discipline
Minimum 3+ years related experience; medical device, pharmaceutical or chemical industry
Knowledge of GDP, ANSI, AAMI, ISO, FDA, and USP guidelines related to biocompatibility assessments (i.e. ISO 10993, ISO 22442, etc).
Ability and desire to work effectively in a fast-paced multi-disciplinary team
