Senior Biocompatibility Specialist

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Mahwah, NJ 07430, United States
Job details
Work flexiblity: Hybrid or Onsite Req ID: R529250 Employee type: Full Time Job category: RAQA Travel: 10% Relocation: No

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Job description

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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. Apply Now