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, benchma... more details
Work Flexibility: Hybrid
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.
Travel Percentage: 10%
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.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
