Sr. Scientist, R&D

Position Summary

The Senior Scientist is a key technical contributor within the R&D team, responsible for leading the development, optimization, and validation execution of microbiological and biological test methods for medical device evaluation. This role requires advanced laboratory expertise, deep understanding of biology and microbiology principles, and the ability to independently troubleshoot complex problems. The Senior Scientist drives technical innovation, mentors junior scientists, and leads projects that align with strategic objectives, regulatory requirements, and business priorities. Acting as a subject matter expert, the Senior Scientist collaborates with cross-functional teams, contributes to regulatory and quality initiatives, and represents R&D in both internal and external forums.

Principal Responsibilities

•    Lead laboratory testing activities, applying advanced microbiology and biology techniques to evaluate medical devices in alignment with project objectives and regulatory standards.
•    Design, develop, and validate new test methods, including establishing acceptance criteria, performing statistical analyses, and ensuring clinical relevance.
•    Perform and oversee complex laboratory procedures such as PCR, whole genome sequencing, microscopy, and flow cytometry, act as SME for core microbiological and biological techniques.
•    Troubleshoot complex issues related to testing, instrumentation, or data analysis; independently propose and implement corrective actions using root cause analysis and risk mitigation tools.
•    Prepare and review laboratory documentation, ensuring compliance with good documentation practices (GDP), regulatory standards, and audit readiness, mentor junior staff in technical writing and documentation practices.
•    Generate and review technical reports, work instructions, verification protocols and reports, laboratory reports (LRs), and other design control documentation.
•    Contribute to and lead CAPAs, NC resolutions, and audit preparation activities in support of quality system requirements (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 17025).
•    Manage and execute complex projects independently, identifying critical resource needs and ensuring alignment with business and organizational goals.
•    Train and mentor junior scientists and technicians in advanced laboratory practices, safety, and technical writing.
•    Actively participate in cross-functional teams (Regulatory, Quality, Clinical, Marketing, Procurement, Process Engineering) to ensure project efficiency, compliance, and alignment with strategic objectives.
•    Lead innovative initiatives, identify and implement new laboratory practices and procedures, and evaluate emerging technologies.
•    Represent R&D effectively in cross-functional collaborations and communicate technical findings to leadership and external stakeholders.
•    Apply knowledge of device usage, complications, and clinical trends (e.g., infection, thrombosis, dysfunction) to support product design, methodology development, and regulatory submissions.
•    Ensure compliance with Teleflex’s Code of Ethics and maintain a safe, inclusive, and collaborative laboratory environment.

Education / Experience Requirements

•    Bachelor’s degree in Microbiology, Biology, Biomedical Sciences, or related field with 8+ years of relevant experience, Master’s degree with 5+ years of relevant experience; or Ph.D. with 2–4 years of relevant experience in industry or applied research.
•    Proven expertise in microbiology and biology techniques, including advanced methods (PCR, sequencing, microscopy, flow cytometry).
•    Strong background in test method development, optimization, and validation.
•    Demonstrated experience working within quality-regulated environments (FDA, ISO standards) in medical device, biotech, or pharmaceutical industries.
•    Prior experience leading projects, mentoring junior staff, and contributing to cross-functional collaborations required.

Specialized Skills / Other Requirements

•    Advanced proficiency in laboratory practices, with the ability to implement new methods, optimize workflows, and maintain safety and compliance independently.
•    Strong technical writing skills with the ability to author and review protocols, reports, and procedures for multiple audiences, including regulatory submissions.
•    Proficiency in troubleshooting, corrective action, and root cause analysis; foundational knowledge of risk assessment and mitigation.
•    In-depth understanding of biology and microbiology theory applied to device evaluation, including biofilm mechanics, pathogenicity, and cellular responses.
•    Knowledge of medical device usage, complications, and dysfunctions; ability to apply insights to test methodology and product development.
•    Competency in design control processes, agile systems, and creation of design documentation.
•    Solid knowledge of regulatory and quality standards (FDA 21 CFR Part 820, ISO 13485, ISO 17025).
•    Effective project management skills, including planning, resource identification, and use of tools (Planner, MS Project, Fusion).
•    Strong accountability and ownership, with the ability to oversee multiple projects and deliver results aligned with organizational goals.
•    Highly effective communicator, capable of tailoring messages to technical, cross-functional, and leadership audiences.
•    Basic understanding of cross-functional roles, industry trends, and financial metrics (revenue, COGS, gross profit).
•    Recognized as an emerging leader and influencer within R&D, fostering inclusivity, authenticity, and collaboration across teams.
•    Demonstrated adaptability, resilience, and innovation in navigating shifting priorities and advancing organizational objectives.

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Working Conditions / Physical Demands

TRAVEL REQUIRED: 0 %

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☒ Laboratory