Product Development Specialist Biocomp

The Product Development Specialist Biocomp 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 at Coloplast. This role works in the Product development department and reports to the Director of Research and Product Development. This is a full-time role.

Major Areas of Accountability

• 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; and draw conclusions from biocompatibility and performance testing in project environments dedicated to developing new products.
• Draft biocompatibility plans and reports to establish 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
• Maintain, calibrate, and use laboratory instruments in a safe and reproducible manner.
• Maintain the laboratories' resources inventories, and order lab supplies as needed. Must be comfortable coordinating with vendors by phone and e-mail.
• Anticipated travel: 10%
• Miscellaneous lab and office support duties as needed.
• Kerecis employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
• Other job duties as assigned.

Basic Qualifications

• Bachelor’s degree in Biology, Biochemistry, Chemistry, Biomedical Engineering, Pharmacy, Toxicology, Materials Science, or another related science or engineering discipline.
• 2+ years of experience in biological safety evaluations in the medical device industry.
• A mix of education and work experience in the medical devices industry might be taken into consideration.
• 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. With a track of approved and cleared new devices.
• Excel in verbal and written communication and presentation skills.
• Communicating clearly and convincingly to different stakeholders.

Preferred Qualifications

• Training on ISO 10993 is highly desirable.

Base Salary Range: $89,000 - $130,000

This job description is intended to set forth the core functions required for this position and describe the general nature of the work to be performed. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job. Job duties, responsibilities and activities may change or be supplemented at any time as necessary. Kerecis is an Equal Opportunity Employer. 

62403
#LI-KR