Staff Scientist
Staff Scientist
Posted on :
26-06-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Hybrid
What you will do-
This role leads the development and implementation of testing protocols ensuring compliance with medical device regulations and standards. The position plays a key role in cross-functional projects supporting new product development sustaining activities and quality initiatives. As a subject matter expert (SME) the individual will guide others influence internal and external stakeholders and drive process improvements aligned with global regulatory expectations.
- Lead the development of compliant testing protocols for sterilized medical devices supporting both new product development and sustaining engineering.
- Act as a subject matter expert (SME) during business development activities audits quality investigations and cross-functional initiatives.
- Interpret and apply international standards related to sterilization cleaning disinfection and biocompatibility while mentoring junior staff.
- Lead or contribute to quality system improvements including authoring or revising procedures and serving as a Divisional Process Owner (DPO).
- Guide technical problem-solving including addressing customer complaints non-conformances and field actions using strong technical expertise.
- Apply knowledge of clinical use manufacturing processes and financial impacts to enhance product development and testing strategies.
- Represent the company in industry standards development advise on regulatory changes and ensure global compliance across divisions.
- Collaborate across R&D Quality Regulatory and Marketing teams leading and mentoring others to ensure project success and alignment with business goals.
What you need-
Required:
- Bachelors degree in biology Microbiology Chemistry or Biomedical Engineering.
- Minimum of 6 years of relevant work experience.
- Ability to occasionally lift to 10 pounds (light physical work). Manual dexterity and coordination of eye hand and foot movements. Ability to grasp objects by hand.
Desired
- Strong knowledge of FDA GMP ISO and other medical device regulatory requirements.
- Proficient in cleaning disinfection sterilization validation and biocompatibility testing within regulated environments.
- In-depth expertise with multiple sterilization methods (e.g. irradiation ethylene oxide vaporized hydrogen peroxide moist heat).
- Skilled in interpreting and developing standards analyzing test results and resolving validation issues.
- AAMI CISS certification.
Required Experience:
Staff IC
Employment Type
Full-Time
Key Skills
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