Senior Biocompatibility Engineer (Remote) - Minnesota, Bloomington 10801 Nesbitt Avenue South

Work Flexibility: Remote or Hybrid or Onsite

Senior Biocompatibility Engineer (Remote) 

Stryker is hiring a Senior Biocompatibility Engineer to support our Trauma and Extremities (T&E) business. As a Senior Biocompatibility Engineer, you will be a Subject Matter Expert in a senior scientific role with ultimate authority to determine biological safety for T&E products. You will collaborate with Manufacturing, Quality, R&D, Regulatory Affairs as well as external laboratories and regulatory bodies to drive state of the art in T&E products and processes. 

Work Flexibility: Remote with reasonable proximity to our Stryker facility in Columbia, IN or Bloomington, MN or Mahwah, NJ or Memphis, TN.

Who we want 
Dedicated achievers: People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 
Goal-oriented developers: Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions. 
Collaborative partners: People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. 

Detail-oriented process improvers: Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 

What you will do 

• Plan and evaluate biocompatibility studies and special process validations in support of implantable and non-implantable medical devices. 
• Review, evaluate, interpret, and apply internal and external guidance documents as they relate to cleanliness and biological safety.
• Develop technically sound protocols, reports, regulatory summaries, and verification of methods and results in collaboration with business partners, global manufacturing sites, test laboratories and suppliers. 
• Identify, analyze, and participate in selection of materials, design, suppliers, and processes to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety.   
• Develop and execute project plans to include definition of scope, timelines, critical path management, resources, and budgets. 
• Lead and conduct biological safety hazards risk analysis.  
• Interface with key business partners and represent biocompatibility on new product development teams. 
• Make positive contributions, recommend approaches and support updating/ developing procedures. 

What you need 

Basic Qualifications: 

• Bachelor’s Degree in Biology, Microbiology, Science, Engineering or a closely related field.  
• 2+ years of experience in medical device industry, expertise in cleaning, biocompatibility, chemistry, special process validation and/or working in a lab.  

Preferred Qualifications: 

• Proven experience working with and understanding requirements for biocompatibility with knowledge of relevant ISO 10993 series and relevant country specific regulations strongly preferred. 
• Possess knowledge and understanding of sterilization, cleaning, packaging and biocompatibility 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. 
• Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables. 
• Knowledge and understanding of manufacturing contaminants and establishing residual limits. 
• Must be team oriented, with the ability to motivate and work well with diverse cross-functional teams. 
• Must possess strong analytical and process skills, and be computer proficient in Excel, MS Teams, PowerPoint, Word, SharePoint, etc. 
• Ability to interact at the highest professional manner with all organizational levels in person and in a virtual setup. 
• Demonstrated ability to draw conclusions, present and make recommendations based on 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 interact with and contribute constructively to a global team environment, outside departments and externally. 

$75,300.00 - $156,900.00 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.