Staff Scientist
- Be responsible for providing technical support to various areas of the business including biocompatibility, cleaning, disinfection, and sterilization of reusable and single use medical devices.
- Collaborate closely with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
- Develop and implement compliant testing protocols and guidelines to support regulatory submissions for new and existing medical devices.
- Coordinate and deliver project milestones in partnership with cross-functional teams, ensuring timelines and quality standards are met.
- Interpret and apply international standards for sterilization, cleaning, disinfection, and biocompatibility; mentor team members on best practices.
- Lead investigations and resolve complex technical issues, including customer complaints, adverse events, and non-conformances.
- Perform gap assessments on evolving standards and drive updates to quality system procedures.
- Serve as a subject matter expert during internal and external audits and regulatory interactions.
- Create and refine documentation for sterilization, biocompatibility, and reusable device processing evaluations in compliance with design control procedures.
- Train and guide junior team members to build technical expertise and ensure consistent execution.
- Bachelor's degree in Biology, Microbiology, Chemistry, Biomedical Engineering, or a related scientific degree.
- Minimum 4 years of experience in medical device or related regulated industry.
- Proven knowledge of FDA and GMP standards.
- Familiarity in sterilization validation principles and biocompatibility testing within a regulated environment.
- Master's degree in a related field.
- Experience with multiple sterilization modalities (e.g., irradiation, ethylene oxide, vaporized hydrogen peroxide, moist heat).
- Familiarity with ISO standards for medical devices (ISO 13485, ISO 10993, ISO 11135)
- Familiarity with environmentally controlled area qualification principles.
- AAMI CISS certification is desirable
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