Job Description

Work Flexibility: HybridWho we want:Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.Self-directed initiators. People who take ownership of their work, results-oriented, and need no prompting to drive productivity, change, and outcomes.Team-players. People who can collaborate globally and thrive when developing lasting interpersonal relationships.What you will do:Lead new product development and/or changes to medical devices currently in the market for sterilization.Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.Lead/support NC and CAPA activities.Lead departmental initiatives including setting timelines and milestones.Review/approve product and process change control documentation and specifications.Support product transfers to other plants/facilities.Partner with cross functional teams including (RA, AO, Ops) to ensure business unit project timelines are met.Partner with team by contributing to the development, maintenance, and improvements of the policies and procedures related to sterilization.May support in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).Act as sterilization subject matter expert to align to best practices, benchmarking against industry leads and regulatory requirements.Lead root cause analysis, problem solving, and out-of-specification investigations.Define validation activities (i.e. product adoptions, testing plans, etc.).Train and guide team members junior to you and other functions in area of sterilization.What we need:Required:M.Sc. in Microbiology/Applied Microbiology/Biological Sciences or related discipline.5+ years related experience, medical device, pharmaceutical or chemical industry.Preferred:At least 2+ years of experience in medical device industry.Knowledge of GDP, ANSI, AAMI, ISO, FDA, and USP guidelines related to sterilization (i.e. ISO 17665, ISO 11137, ISO 11135, etc.).Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide, moist heat, or dry heat and be an expert in one of the techniques.Demonstrated ability to effectively communicate, manage projects, and influence as well as can prioritize and manage multiple tasks simultaneously.Ability and desire to work effectively in a fast-paced multi-disciplinary team environment.Strong interpersonal skills including strong written and oral communication. Strong in critical and analytical thinking.Highly developed problem-solving skills. Demonstrated ability to write technical documentation.Demonstrated ability to successfully manage and complete projects in a matrix organization. Demonstrated ability to work independently.Travel Percentage: 10%

Stryker