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Senior Staff Biocompatibility Specialist - Hybrid

Mahwah, NJ

Stryker is hiring a Senior Staff Biocompatibility Specialist to support our Joint Replacement division.

In this role, you will Lead new product development and/or changes to medical devices currently on the market for biocompatibility/toxicology.

Work Flexibility: Hybrid.

This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3 days onsite.

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:

• Lead biocompatibility toxicological assessments, evaluate test data, and present results to cross-functional team.

• Lead complex departmental initiatives, which may require cross functional collaboration, including setting timelines and milestones.

• Write and present technical and scientific documentation .

• Evaluate the optimization and implement improvements in the policies and procedures related to biocompatibility.

• Act as biocompatibility subject matter expert to align to best practices, benchmarking against industry leads and regulatory requirements.

• Lead root cause analysis, problem solving, out-of-specification investigations, as well as associated risk assessments.

• Evaluate validation and verification approaches for biocompatibility (i.e. product adoptions, testing plans, etc.).

What you need:

Required:

• BS in Chemistry/Biochemistry/Toxicology or related discipline

• 6+ years of experience in medical device, pharmaceutical or chemical industry

Preferred:

• MS in Chemistry/Biochemistry/Toxicology or PhD in Chemistry/Biochemistry/Toxicology or related discipline

• Expert knowledge of GDP, ANSI, AAMI, ISO, FDA, and USP guidelines related to biocompatibility assessments (i.e. ISO 10993, ISO 22442, etc).

• Demonstrated ability to effectively communicate, manage projects, and influence as well as can prioritize and manage multiple tasks simultaneously.

• Ability to work effectively in a fast-paced multi-disciplinary team environment.

• Strong in critical and analytical thinking.

• Highly developed problem-solving skills.

• Demonstrated ability to write technical documentation.

• Demonstrated ability to successfully manage and complete projects in a matrix organization.

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.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.