Work Flexibility: Hybrid or Onsite
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
Travel Percentage: 10%