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. *Willing to review candidates with Microbiologist background*
Bachelor’s Degree in Biology, Microbiology, or a closely related life science. Identify, isolate and study microorganisms and their byproducts as it relates to the manufacturing and sterilization of medical devices.
Practice two or more of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat.
Review biocompatibility tests and interpret the associated industry guidelines. Work with operations and research groups to develop new products and support continuous quality improvement initiatives.
5+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
Must understand the fundamentals of two of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat.
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.