Scientist, R&D - Combination Technologies

Position Summary

The Scientist is responsible for conducting microbiological and biological testing, optimizing methods, and supporting new test method development for the evaluation of medical devices. This role requires a solid foundation in microbiology and biology theory, proven competency in laboratory practices, and the ability to troubleshoot, analyze, and interpret experimental results with minimal supervision. The Scientist contributes to project deliverables, supports regulatory and design control activities, and provides technical expertise to cross-functional teams. The position also involves mentoring junior staff, reviewing documentation, and participating in innovative initiatives that enhance laboratory efficiency and quality.

Principal Responsibilities

•    Conduct microbiology and biology testing in support of R&D, method development, and medical device evaluation, ensuring compliance with protocols, quality systems, and regulatory requirements.
•    Prepare, optimize, and perform biological assays and laboratory procedures, including aseptic techniques, media preparation, and device-related testing.
•    Troubleshoot instrumentation, methods, and results; provide initial corrective action proposals, escalating as needed.
•    Document all experimental work using good documentation practices (GDP), ensuring accuracy, completeness, and regulatory compliance.
•    Summarize and communicate data clearly in reports, presentations, and cross-functional discussions; review and approve junior team members’ laboratory notebooks and reports.
•    Assist in test method design, optimization, and validation to improve efficiency, accuracy, and compliance.
•    Apply biological and microbiological principles to interpret results, make connections across steps, and explain reasoning behind test protocols.
•    Contribute to design control deliverables (e.g., IMHs, VERs, LRs), supporting regulatory submissions and quality system compliance.
•    Support lab quality initiatives, including nonconformance (NC) resolution, CAPAs, and internal audit readiness.
•    Take ownership of small-scale projects, managing timelines, resources, and reporting while supporting senior scientists on larger initiatives.
•    Train and mentor junior staff in laboratory techniques, documentation, and safety practices.
•    Actively contribute to innovation by identifying process improvements and collaborating with cross-functional stakeholders.
•    Represent R&D in cross-functional meetings, aligning project objectives with company goals and contributing to strategic discussions.
•    Uphold Teleflex’s Code of Ethics, maintain a safe laboratory environment, and model professional and ethical conduct.

Education / Experience Requirements

•    Bachelor’s or Master’s degree in Microbiology, Biology, Biomedical Sciences, or related field.
•    2–4 years of relevant laboratory experience (medical device, microbiology, or related industry preferred).
•    Demonstrated competency in aseptic techniques, microbial culture preparation, serial dilutions, and biology/microbiology test methods.
•    Experience with documentation, method optimization, and cross-functional collaboration.
•    Familiarity with regulatory and quality frameworks (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 17025) preferred.

Specialized Skills / Other Requirements

•    Proficiency in laboratory practices, including aseptic techniques, solution/media preparation, and instrumentation use and maintenance.
•    Strong technical writing and communication skills, with the ability to prepare reports, protocols, and technical documentation for diverse audiences.
•    Ability to review and approve data and reports generated by junior staff, ensuring accuracy and compliance.
•    Foundational knowledge of root cause analysis tools (Fishbone, 5 Whys, Six Sigma, CAPA) with ability to contribute to problem-solving efforts.
•    Understanding of microbiology and biology principles relevant to medical devices (biofilm formation, pathogenicity, molecular biology, cellular response).
•    Familiarity with medical devices, their clinical use (PICC, CVC, AHDC, etc.), and associated complications such as infection and thrombosis.
•    Working knowledge of design control principles and agile documentation systems.
•    Awareness of regulatory requirements for medical device testing and development.
•    Effective time and project management skills with the ability to manage multiple assignments, track progress, and meet deadlines.
•    Strong accountability, ownership, and initiative in managing tasks and small projects.
•    Ability to influence cross-functional teams through clear, data-driven communication.
•    Collaborative, inclusive, and adaptable mindset, fostering teamwork and continuous improvement.
•    Commitment to ethical standards, safety, and compliance in all laboratory and project activities.

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Working Conditions / Physical Demands

TRAVEL REQUIRED: 0 %

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