$80K — $100K *
This position has the responsibility of working in R&D to support the remediation of products relative to the European Medical Device Regulation (MDR), ensuring products maintain internal quality standards, and comply with the international standards. Job responsibilities include addressing well-defined problems of limited scope and following standard practices and procedures. Individual will be part of the team that is responsible for ensuring all the product related documentation related to biological risk assessment is remediated to the standards required by the MDR legislation (Regulation 2017/745 of the European Parliament and of the Council).
Prepare biological evaluation plans and obtain all the necessary approvals from cross-functional teams. Write biological risk assessment to ensure all the relevant end points mentioned in ISO 10993 are met. Take into consideration factors such as surgical technique (clinical use conditions), design, manufacturing processes, contacting chemicals, testing data, chemical extraction information, cleaning validation, sterilization, and complaints database (post market data). Proactively consult with senior toxicologists and/or biocompatibility manager on data interpretation and completion of toxicological risk assessments.
Liaise with internal (manufacturing, regulatory, quality, product development, supplier quality, post market surveillance, clinical) and external contacts (contract research organization (CRO), suppliers of raw materials and semi or finished products) to collect all relevant device information.
Document and maintain records of original information. Assist more senior members of the team in updating procedures, internal processes, data collection, and report writing.
Maintain and update various databases used by research teams. Comply with research laboratory health and environment practices.
Pursue internal and external training to advance expertise in biocompatibility and toxicology. Develop expertise in Smith+Nephew’s Orthopedics portfolio.
Location: Memphis TN
· Bachelor’s Degree (in engineering or relevant discipline in biomedical science) with 2-4 years relevant experience in the medical device industry.
· MSc/MEng in an engineering or scientific discipline such as Biology, Biochemistry, Chemistry, Pharmacology, Biomedical Engineering and 1-2 years relevant experience.
· PhD in relevant discipline with 0-1 years relevant experience (including post-doctoral training).
Licenses/ Certifications: NA
· 0-1 years’ experience (including post-doctoral training) with doctorate
· 1-2 years’ experience with master’s
· 2-4 years’ experience with Bachelor’s Degree (in engineering or relevant discipline in biomedical science)
· Publication record, including first author manuscripts in a peer-reviewed journals, strongly preferred.
· Competences: Working knowledge of organic chemistry, biochemistry, and biology. Proficient in mathematics. Ability to prepare documents with rigorous attention to detail. Strong writing and grammatical skills a plus.
· Physical Demands: Packing instruments or devices for sterilization and/or testing may occasionally be required; occasional laboratory projects may require ambulation within and between buildings; >50% desk/computer work; periodic travel between Memphis campuses, out-of-town travel infrequently required
Travel Requirements: <10%
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Valid through: 11/10/2020