Staff Biocompatibility Engineer/Scientist

Work Flexibility: Remote

Stryker is hiring a Staff Biocompatibility Engineer/Scientist (Remote) to support our Foot and Ankle business through our Trauma and Extremities division to lead product safety and/or verification and validation test campaigns of osteosynthesis and arthroplasty products.

Who we want:

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.
• Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and are driven to complete projects that meet regulations and expectations.

What you will do:

• Provides support and directions to other engineers and scientists in the field of Biological Sciences. Partners with cross-functional project team members to define evaluation / verification strategies of medical devices.
• Works with minimal supervision, conferring with superior on unusual matters. Assignments are broad in nature, requiring originality and ingenuity.
• Plan, execute, evaluate, and document biocompatibility studies and justifications in support of product safety and performance tests.
• Develop technically sound test campaigns, protocols, reports, regulatory summaries, and verification of methods and results in collaboration with project team, test laboratories, and suppliers.
• Review, evaluate, interpret, and apply internal and external guidance documents as they relate to biocompatibility.
• Make positive contributions, recommend approaches, and support updating / developing internal procedures that comply with applicable global regulatory requirements.
• Oversee subject matter expertise related to international standardization (ISO, ASTM, FDA guidance, others) and implement requirements into guidelines.
• Identify and analyze materials, design, and process challenges to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety.
• Responsible for identifying critical process factors and their effects on biological safety.
• Develop and execute project plans to include definition of scope, timelines, critical path management, resources, and budget as they relate to biocompatibility.
• Interface with key business partners and represent biocompatibility team on new product development teams.
• Manage external test campaigns (i.e. biocompatibility and chemical testing).
• Initiate and communicate best practices and methodologies with Biological Sciences team and cross-functional team members, as appropriate.
• Provide technical leadership to interns, technicians, specialists, scientists and engineers related to Biological Sciences.

What you will need

Required :

• Bachelor's Degree in Engineering or a Science is required
• Minimum of 5 years in a Biological sciences, biocompatibility, Quality or Regulatory role in the medical device industry.
• Possess knowledge and understanding of biocompatibility-related processes and contamination controls, principles, practices, and procedures of the field including ISO standards and compliance.
• Direct experience in biological evaluation of medical devices per ISO 10993.

Preferred:

• Bachelor's Degree in Engineering or Science with a focus in Chemistry or Biological Sciences preferred.
• Demonstrated ability to successfully contribute to and lead complex verification / validation test campaigns.
• Demonstrated ability to apply design controls within a regulated industry.
• Demonstrated knowledge and ability to apply fundamental and advanced concepts, practices, and procedures regarding biocompatibility.
• Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables.
• Must be team oriented, with the ability to motivate and work well with diverse cross-functional teams.
• Must possess strong analytical skills and be detail oriented.
• Must be computer proficient in Excel, Project, PowerPoint, Word, etc.
• Demonstrated ability to draw conclusions, present and make recommendations based on analytical data and technical inputs from multiple and varied functions (i.e. Manufacturing, Quality, Regulatory, Design, Sourcing).
• Excellent communication skills, both verbal and written, and interpersonal skills to effectively and professionally interact with and contribute constructively to a global team environment, outside departments and externally.
• Demonstrated ability to lead complex initiatives from concept through release.
• Demonstrated ability to achieve work objectives both independently and as a leader/member of a work team.

85,500.00 to 182,100.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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.