Based in our Telford, PA facility, the Sr. Scientist will be primarily responsible for driving early stage research centered on the use of biomaterials in developing medical devices in the cardiovascular and cardiac fields. This includes bringing a product from concept through design, prototyping, development testing, design verification and validation, and manufacturing. This individual will work with both internal and external resources in developing and testing new device designs.
Working with a high degree of independence, leads biomedical research efforts focused on the development of cardiovascular devices using novel biomaterials.
Develops protocols for in vitro and in vivo evaluation of biocompatibility and efficacy.
Plan and manage academic collaborations and outside studies with CRO's.
Provides technical leadership to cross-functional project teams within field of expertise.
Reviews and critically assesses patents and other forms of intellectual property.
Actively develops intellectual property through the filing of patent applications.
Presents research results national and international technical meetings.
Coaches and mentors junior level researchers.
Clearly communicates technical information and project status to supervisor and colleagues through written and verbal means.
Accurately and thoroughly documents procedures and results using laboratory notebooks, protocols & reports, records and databases.
Effectively collaborates with colleagues on laboratory techniques, sample preparation, instrumentation, data analysis and documentation.
Follows all applicable Company test methods, work instructions, S.O.P.’s, and guidelines.
Performs other job-related responsibilities as assigned.
Daily exposure to a chemical lab environment, eye protection, safety footwear and additional PPE, as required.
Occasional exposure to a manufacturing environment and environmentally controlled rooms. Gowning is required to work in these rooms.
Must follow company Safety Policy and Chemical Hygiene plan.
Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements.
Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
Follows gowning procedures in designated areas.
May be required to be fit for a respirator and adhere to the Respiratory Practice Program, depending on specific chemical handling.
Must be able to work with minimal supervision.
Bachelor's degree in the fields of Biomedical Engineering, Tissue Engineering, Chemistry, Biology, Materials Science or equivalent. PhD is highly desirable.
5+ years’ direct experience in biomedical research and development of cardiovascular or cardiac devices.
Direct experience with ISO 10993 and FDA Design Controls.
Practical experience with DSC, TGA, FTIR, UV/Vis, GPC, HPLC, GC, Rheology, SEM, and Mechanical Testing.
Prior work experience in a regulated environment (ISO 9001, 13485 and QSR Standards) a plus.
Strong understanding and practical hands-on experience with biomaterials characterization and experience with cell culture studies.
Detail-oriented, organized, hands-on with drive for solving problems in a timely manner.
Ability to accurately analyze data generated by various analytical and physical testing instrumentation.
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Internal Number: SRSCI01095
About Secant Group
The Secant Group is an advanced technology biomaterials company headquartered in Telford, Pennsylvania, with manufacturing facilities in Quakertown and Perkasie, Pennsylvania. Secant provides innovative solutions through next-generation materials, structures, textile designs, and process technologies for the medical device, pharmaceutical, aerospace and energy markets.