Offer summary

Qualifications:

Bachelor's Degree in Engineering or a Science, preferably with a focus in Chemistry or Biological Sciences., 2+ years of experience in biological sciences or biocompatibility in the medical device industry., Direct experience in biological evaluation of medical devices per ISO 10993., Strong analytical skills, attention to detail, and excellent communication skills..

Key responsabilities:

Plan, execute, evaluate, and document biocompatibility studies for product safety.

Develop test campaigns, protocols, reports, and regulatory summaries in collaboration with project teams.

Identify and analyze materials and process challenges to ensure biological safety.

Act as a biocompatibility subject matter expert and interface with key business partners on new product development.

Job description

Work Flexibility: Remote

Senior Biocompatibility Engineer (Remote)

Stryker is hiring a Senior Biocompatibility Engineer (Remote) to support our Trauma and Extremities division to lead product safety and/or verification and validation test campaigns of orthopedic products.

What you will do:

Plan, execute, evaluate, and document biocompatibility studies and justifications in support of product safety.
Develop technically sound test campaigns, protocols, reports, regulatory summaries, and verification of methods and results in collaboration with project team and test laboratories.
Partner with cross-functional project team members to define evaluation / verification strategies of medical devices.
Make positive contributions, recommend approaches, and support updating / developing internal procedures that comply with applicable global regulatory requirements.
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 act as biocompatibility subject matter expert on new product development teams.

What you will need:

Required:

Bachelor's Degree in Engineering or a Science.
2+ years of experience in a biological sciences or biocompatibility in the medical device industry.
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.
Possess strong analytical skills and be detail oriented.
Knowledge of design controls within a regulated industry.
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.

$77,200.00 - $160,800.00 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: None

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.

Required profile