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Job Summary
In this hybrid fixed term role (2 days remote, 3 days in office), you will be part of the Materials & Biological Safety (MBS) team, responsible for creating and maintaining material data and biological safety information, for medical devices manufactured by our company. as Materials & Biological Safety Associate Specialist. You will be responsible for providing ongoing material and biological safety support for R&D and Engineering teams and regulatory submissions.
Essential Duties and Responsibilities
Local/site point of contact for internal employees, external clients and service providers regarding materials and biological safety of West Medical Devices platforms mainly VTD and V2B.
Support the design and development teams with materials research, evaluation, and selection. Liaise with Product Design, Validation & Verification and Project Managers/Leads to achieve project goals through high quality, accurate and timely completion of deliverables.
Responsible for directing external/third-party biocompatibility testing service providers and coordinate testing at external labs.
Coordinate, build and procure sample devices from the manufacturing plant for use in biocompatibility and/or chemical characterization evaluations.
Create (author) and/or review and approve biocompatibility test plans, protocols, and reports.
Create (author) and/or review and approve biological gap assessments for Medical Devices and manufacturing process.
Create (author) and/or review Biological Risk Assessment (BRA) /Toxicological Risk Assessment (TRA) in preparation for completing biocompatibility testing and chemical characterization programs.
Provide general ongoing materials and biological safety support with customer requests/inquiries, regulatory body or customer audits, and regulatory submissions.
Maintain thorough understanding of relevant ISO standards, quality system and laboratory testing accreditation requirements.
Requirements: Education
B.S. in Materials Science, Biomedical Engineering, or related degree required or equivelent experience will be considered.
Work Experience
Minimum 2 years of R&D experience in Medical Device/Pharmamedical required
Preferred Knowledge, Skills and Abilities
Biological safety and/or materials safety - Advantage
Experience in biological safety of medical devices.
Experience in medical device design, development and manufacturing.
Experience in applying and adhering to relevant global standards and regulations, specifically the ISO 10993 family.
Strong technical writing skills for authoring test plans, protocols and reports.
Knowledge of medical devices Design Controls and Risk Management.
This position is open to all candidates.