Accentuate Staffing is recruiting for a medical device sterilization engineer with a global medical device manufacturer in the Durham, NC area. It’s a full time perm role with lots of growth opportunities for the future.
- Oversee all sterilization and microbiological methods and processes related to products designed and manufactured as well as purchased products labeled and sold.
- Review and approve sterilization cycle development, process validations, equivalency reviews, alternate sterilization methods and facilities, and microbiological controls. Evaluate new products, including custom and made-to-order kits, for impact of sterilization.
- Prepare and execute sterilization validations and test protocols/reports for all internal and external sterilization facilities.
- Provide support when evaluating the impact/efficacy of existing sterilization methods on new products or new product designs
- Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods.
- Maintain and execute a sterilization and biocompatibility program/policy to ensure all products and processes comply with the regulatory standards.
- Provide input to creating strategies to assure compliance to regulatory standards regarding sterilization for products.
- B.S. Degree in B.S. in Biology, Chemistry, Microbiology, or other related science, or Engineering with strong chemistry or biology background.
- Knowledge / experience in EO and gamma radiation sterilization
- Regulatory, cGMP, QSR knowledge base
- Statistical knowledge (DOE, SPC, Sample comparison, etc.)
- Strong communication skills (written and verbal)
- Ability to communicate and operate effectively with multiple teams
- Negotiation and strong problem-solving skills
- Computer literate (MiniTab, Word, Excel, etc.)
- Ability to adapt to shifting priorities, work with minimal supervision, resolve problems/conflicts, and demonstrate solid reasoning ability