Description

Job Description: Product Development Scientist

The Product Development Scientist is part of a small but seasoned team of medical device professionals responsible for the development and commercialization of the Company’s next-generation products across its wound, burn, and surgery markets.

The Product Development Scientist is based in the Kerecis Minneapolis office and reports to the Director of Research and Product Development.

Essential Functions 

• Perform laboratory experiments and      product testing for research, technology, and product development, and      report results
• · Analyze data collected in project experiments using graphical and statistical methods
• · Act as a subject-matter expert on biological evaluation of medical devices (ISO 10993)
• · Evaluate and plan biocompatibility studies in support of projects
• · Analyze, interpret, and gather necessary data sets; draw conclusions from biocompatibility testing
• · Draft biocompatibility protocols and reports for establishing biological safety evaluations
• · Critically review protocols, reports, toxicological risk assessments, and regulatory summaries
• Clearly      and efficiently communicate research progress using presentation tools in      weekly group and project meetings
• Demonstrate      effective time management and efficiency through careful planning and      multitasking

Secondary Functions 

• Support under supervision pre-clinical studies planning and execution
• Educate and supervise other staff regarding the biological evaluation process of medical devices
• Maintain, calibrate, and use laboratory instruments in a safe and reproducible manner
• Monitor laboratory resource inventories, and order lab supplies as needed
• Coordinate with vendors by phone and e-mail as needed
• Miscellaneous lab and office support duties as assigned

Requirements

Requirements

Competencies

· Expert on biological evaluation of medical devices (ISO 10993)

· Leadership on establishing biological safety evaluations from start to end

· Experienced in the development of FDA-regulated medical devices

· Excellent verbal and written communication and presentation skills

· Ability to communicate clearly and convincingly to different stakeholders

Education & Experience

 

· PhD in Biology, Biochemistry, Chemistry, Biomedical Engineering, Pharmacy, Toxicology, Materials Science, or other related science or engineering discipline from an accredited college or university

· 3 to 5 years of experience in biological safety evaluations in the medical device industry

· A combination of education and work experience in the medical device industry will be considered

· Training on ISO 10993 highly desirable

Anticipated travel: 10%

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis LLC is an equal opportunity employer.