Senior Staff Biocompatibility Scientist

Tempe, AZ - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Senior Staff Biocompatibility Scientist for our Sustainability Solutions team within the Endoscopy division. In this role youll lead biological safety strategies for new and reprocessed medical devices serving as the biocompatibility subject matter expert. Youll translate regulatory requirements and scientific data into actionable plans that ensure compliance and accelerate product development. This position involves strategic collaboration across QA RA R&D and PMO to drive design decisions and bring innovative sustainable solutions to market.

Strykers Sustainability Solutions (SSS) is committed to sustainable healthcare; changing the way healthcare thinks about single-use devices and extending the life through reprocessing. Flexibility: Candidate must reside within a commutable distance to Tempe AZ but is expected to be onsite at the facility multiple times/week.

What you will do:

Author Biological Safety Documentation: Independently create Biological Safety Evaluations Plans and Reports in compliance with ISO 10993-1 and global regulatory standards.
Design & Evaluate Testing Strategies: Develop and critically assess biocompatibility test plans data and special process validations for medical device cleaning and reprocessing.
Risk-Based Change Assessment: Analyze material process and supplier changes to determine biological safety impact and implement cost-effective scientifically justified strategies.
Regulatory Expertise & Support: Provide expert input for regulatory submissions and respond to agency inquiries with clear evidence-based rationale.
Cross-Functional Collaboration: Partner with R&D Quality Manufacturing Regulatory and other teams to align strategies and deliver project milestones.
External Representation & Standards Development: Represent the organization in AAMI ISO and corporate working groups to influence standards and best practices.
Leadership & Mentorship: Serve as biocompatibility SME mentor junior team members and communicate complex concepts to diverse audiences including senior leadership.
Continuous Improvement & Innovation: Drive enhancements in procedures policies and systems to optimize biological safety and sustainability initiatives.

What you need:

Required

Bachelors degree in Biology Microbiology Biomedical Engineering or a closely related scientific field
Minimum of 6 years of relevant experience including 4 years leading technical biocompatibility projects in the medical device industry with proven expertise in biological evaluation per ISO 10993-1covering material characterization endpoint selection and risk-based justification.
Strong knowledge of microbiological principles cleaning validation and reprocessing requirements for both terminally sterile and reusable products.
Proven ability to apply ISO FDA and related regulatory guidelines in product design manufacturing and development of strategic innovations.
Expertise in authoring and reviewing technical documentation (e.g. BEPs BERs risk assessments protocols reports) with high scientific rigor.

Preferred

Advanced degree (M.S. or Ph.D. in a relevant scientific discipline (e.g. Biology Microbiology Biomedical Engineering Chemistry or Toxicology)
Active membership in external professional groups such as AAMI SOT AORN etc
Proven ability to develop and optimize biological test strategies including biocompatibility assessments aligned with ISO 10993 and country-specific regulations.
Experience with biomaterials microbiology and sterility processes (e.g. Ethylene Oxide Steam Radiation VHP) as well as endotoxin (LAL) and bioburden testing for medical devices.
Skilled in managing biocompatibility testing with external laboratories.
Experience working closely and coordinating sterilization activities with contract sterilizers operations sourcing and regulatory teams.
Strong project management capabilities including detailed planning task management and defining deliverables.
Prior exposure to reusable or reprocessed medical devices and sustainability-focused product design initiatives.

Travel Percentage: 20%

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 contractors legal duty to furnish information.

Required Experience:

Staff IC

Work Flexibility: Hybrid or OnsiteStryker is hiring a Senior Staff Biocompatibility Scientist for our Sustainability Solutions team within the Endoscopy division. In this role youll lead biological safety strategies for new and reprocessed medical devices serving as the biocompatibility subject matt...

Work Flexibility: Hybrid or Onsite

What you will do:

Author Biological Safety Documentation: Independently create Biological Safety Evaluations Plans and Reports in compliance with ISO 10993-1 and global regulatory standards.
Design & Evaluate Testing Strategies: Develop and critically assess biocompatibility test plans data and special process validations for medical device cleaning and reprocessing.
Risk-Based Change Assessment: Analyze material process and supplier changes to determine biological safety impact and implement cost-effective scientifically justified strategies.
Regulatory Expertise & Support: Provide expert input for regulatory submissions and respond to agency inquiries with clear evidence-based rationale.
Cross-Functional Collaboration: Partner with R&D Quality Manufacturing Regulatory and other teams to align strategies and deliver project milestones.
External Representation & Standards Development: Represent the organization in AAMI ISO and corporate working groups to influence standards and best practices.
Leadership & Mentorship: Serve as biocompatibility SME mentor junior team members and communicate complex concepts to diverse audiences including senior leadership.
Continuous Improvement & Innovation: Drive enhancements in procedures policies and systems to optimize biological safety and sustainability initiatives.

What you need:

Required

Bachelors degree in Biology Microbiology Biomedical Engineering or a closely related scientific field
Minimum of 6 years of relevant experience including 4 years leading technical biocompatibility projects in the medical device industry with proven expertise in biological evaluation per ISO 10993-1covering material characterization endpoint selection and risk-based justification.
Strong knowledge of microbiological principles cleaning validation and reprocessing requirements for both terminally sterile and reusable products.
Proven ability to apply ISO FDA and related regulatory guidelines in product design manufacturing and development of strategic innovations.
Expertise in authoring and reviewing technical documentation (e.g. BEPs BERs risk assessments protocols reports) with high scientific rigor.

Preferred

Advanced degree (M.S. or Ph.D. in a relevant scientific discipline (e.g. Biology Microbiology Biomedical Engineering Chemistry or Toxicology)
Active membership in external professional groups such as AAMI SOT AORN etc
Proven ability to develop and optimize biological test strategies including biocompatibility assessments aligned with ISO 10993 and country-specific regulations.
Experience with biomaterials microbiology and sterility processes (e.g. Ethylene Oxide Steam Radiation VHP) as well as endotoxin (LAL) and bioburden testing for medical devices.
Skilled in managing biocompatibility testing with external laboratories.
Experience working closely and coordinating sterilization activities with contract sterilizers operations sourcing and regulatory teams.
Strong project management capabilities including detailed planning task management and defining deliverables.
Prior exposure to reusable or reprocessed medical devices and sustainability-focused product design initiatives.

Travel Percentage: 20%

Required Experience:

Staff IC

Key Skills

Laboratory Experience
Bioinformatics
Biochemistry
Utility Locating
Assays
Research Experience
Next Generation Sequencing
Sensors
Signal Processing
Matlab
Research & Development
Molecular Biology

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About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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