Job Description

Work Flexibility: Hybrid

Qualifications & Work Experience

• 8+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
• Must be an expert in one of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat, and understand the fundamentals of the others.
• Demonstrated experience with biocompatibility tests, ability to interpret the associated industry guidelines.
• Prefer demonstrated competency in advanced testing technologies.
• Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures.
• Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives.
• Ability to effectively work cross-functionally with Product Development, Operations and Marketing.
• Demonstrated ability to manage workload.
• Demonstrated communication skills across different organizational levels.
• Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
• Demonstrated ability to technically mentor associate engineers and scientists.

Job Summary
Ensure the microbiological quality of the areas in which the products are cleaned and packaged, as well as ensure that they are properly sterilized to the appropriate sterility assurance level. Act as subject matter expert (SME) in areas such as parts and facilities cleaning, cleanroom operations, sterilization, and related testing. Work to make sure that the biocompatibility of products using industry guidelines and advanced testing technologies is acceptable. Work closely with operations and research groups to develop new products and lead continuous quality improvement initiatives. Lead and complete projects with minimal supervision

Duties & Responsibilities

• Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopaedic implants and surgical instruments.
• Actively support new product development activities.
• Participate in the development and improvement of the manufacturing processes for existing and new products.
• May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
• Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.
• Support product transfers to other plants/facilities.
• Review/approve nonconforming material and system documentation.
• Review/approve product and process change control documentation and specifications.
• Act as mentor to others.

Travel Percentage: None

Stryker