Job Description
The individual in this position is responsible for evaluating the safety and compatibility of medical devices with biological systems. The role involves planning and placing biocompatibility testing in accordance with ISO 10993 standards, regulatory guidelines, and risk assessment principles. This individual collaborates with cross-functional teams to ensure materials meet safety requirements. This individual analyzes data, prepares technical reports, and supports regulatory submissions. This position may also be involved in developing strategies for new products and addressing biocompatibility-related issues during product development and post-market activities.
Position Responsibilities - Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements.
- Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues.
- Review and interpret laboratory test results; document findings in technical reports and regulatory submissions.
- Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective.
- Stay current with evolving global biocompatibility standards, guidance documents, and regulatory expectations to ensure ongoing compliance.
Responsibilities May Include - Designs, develops, and provides safety testing, repair, and maintenance of biomedical equipment.
- Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards.
- Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes.
- Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays.
Technical Specialist Career Stream An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.
Must Have - Bachelor's degree in materials science, chemical engineering, biocompatibility, or a related technical field. Advanced degrees will also be considered.
- Experience in a regulated industry.
- Knowledge of international and domestic regulations associated with biocompatibility.
- Knowledge of materials and interactions with the body and environment.
- Knowledge of Microsoft applications (Excel, Word, Outlook).
Nice to Have - Demonstrated problem-solving and critical thinking skills.
- Effective verbal and written communication skills.
- Technical understanding of the effect processing has on material properties and performance.
- The ability to work well under pressure.
Differentiating Factors - Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.
- Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.
- Innovation and Complexity: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve the effectiveness of the job area.
- Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.
- Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in Support Career Stream.
Required Knowledge and Experience Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)) and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.
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