Senior Biocompatibility Engineer (Remote)

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

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.

About Stryker

Our benefits:

• 12 paid holidays annually
• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

About 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. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.

Know someone at Stryker?
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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.