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We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

This is a 23 month contract with full Stryker benefits

What you will do:

Technical Responsibilities:

• Independently develop compliant testing protocols and guidelines and support regulatory submissions for new product development and product changes of both terminally sterilized and reusable medical devices.

• Independently coordinate and complete project deliverables in collaboration with cross functional groups such as R&D, Global Quality Operations (GQO), Regulatory, and Marketing.

• Interpret, assess, analyze and apply international standards related to sterilization, cleaning, disinfection and biocompatibility. Mentor others.

• Support technical problems of significant scope and complexity; independently determine and develop approach to solutions. This may include support for quality issues such as customer complaints, adverse events, product field actions, and non-conformances.

• Perform gap assessments to new or changing standards and mentor others.

• Lead the development or revision of quality system procedures for Clinical Sciences. This may include serving as a divisional process owner (DPO).

• Support internal and external regulatory audits as an SME.

• Participate in Corporate wide projects or initiatives; this may include Corporate quality system workgroups.

• Support Regulatory Affairs in interactions with FDA or Competent Authorities on topics pertaining to Clinical Sciences

• Train, provide direction and technical support to junior team members

• Support internal and external customer inquiries

Business Responsibilities:

• Advance solutions by applying in-depth knowledge of customer needs, design inputs and technical areas of responsibility.

• Apply detailed knowledge of with product’s intended use, clinical procedures, and manufacturing process.

• Demonstrate developing financial acumen. Apply knowledge of how test strategies impact development timelines and cost.

• Apply awareness of cultural differences that may exist in business practices in global interactions and mentor others.

Med Device Compliance:

• Be proficient with and mentor others in usage of industry standards, including validation requirements and test strategies per applicable regulations.

• Lead creation and refinement of documentation, such as sterilization evaluations, biocompatibility evaluations, and reusable device processing evaluations, per company design control procedures.

• Follow and mentor others on procedures like terminal sterilization, biocompatibility evaluation, and reusable device processing, per the Quality Management System.

• The role may include support of national and/or international standards committees and workgroups.

General Responsibilities:

• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.

• Identify and support the creation of or improvements to procedures, policies, processes, systems, and technology.

• Support and execute complex projects on multifunctional teams to advance projects through the design /development/launch process.

• Deliver high quality results with passion, energy and drive to meet business priorities.

• Collaborate with cross-functional teams to build partnership to achieve business objectives.

• Demonstrated leadership and interpersonal skills with ability to effectively communicate and lead through influence

PREFERRED QUALIFICATIONS: What you will need (strongly desired):

Technical Skills:

• In depth technical knowledge and understanding of FDA, GMP, ISO, and other medical device regulatory requirements.

• Adept at applying knowledge of cleaning, disinfection, and sterilization validation principles, testing concepts, standards, and practices within a regulated environment.

• Strong technical expertise with multiple sterilization modalities (e.g, irradiation, ethylene oxide, vaporized hydrogen peroxide, moist heat)

• Bachelor of Science in Biology, Microbiology, Chemistry, or Biomedical Engineering.

• 4+ years of work experience

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 150 million patients annually.

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.