Medical Device Research Principal Scientist

Akkodis is seeking a Medical Device Research Principal Scientist for a 12-month contract job with a client in Jacksonville, FL or Warsaw, IN. You will be responsible for leading and supporting investigational and research activities for neuro-based stereotactic products. You will drive research planning, study execution support, outcome tracking, biological evaluation, and risk assessment documentation to support product development and regulatory objectives.

You will serve as a scientific subject matter expert and advisor to cross-functional teams including R&D, Marketing, Sales, Clinical Affairs, and Regulatory Affairs. You will act as a key scientific liaison with external key opinion leaders, laboratories, suppliers, CROs and partner organizations. You will also collaborate across design, process engineering, manufacturing, quality, regulatory, corporate, and site teams to advance research initiatives and support broader neuro-related project needs.

Rate Range: $95.00/hour to $105.00/hour;
The rate may be negotiable based on experience, education, geographic location, and other factors.

Medical Device Research Principal Scientist job responsibilities include:

• Identify, assess, and support the development of new and existing neuro-oncology, neuro-endoscopy, neurosurgery, and other neuro technologies with stereotactic integration.
• Lead or support development, review, and approval of technical documentation, including study protocols, reports, and biological safety risk assessments per ISO 10993.
• Develop strategy for technical investigations and provide scientific expertise to the research team and other cross-functional partners.
• Contribute biological safety content and supporting rationale for regulatory submissions and related technical documents.
• Serve as a subject matter resource for biological evaluation activities related to new product development and sustaining products across the portfolio.
• Coordinate, initiate, and track laboratory studies and associated deliverables.
• Conduct biocompatibility assessments and organize required biological safety testing.
• Support development of testing strategies and biological safety risk assessments for neuro-specific products.
• Present scientific and technical information to internal groups, stake holders, and regulatory bodies as necessary.
• Provide medical and scientific expertise to project teams, marketing, global sales, and medical information functions, as needed.
• Develop materials for project updates, technical reviews, and data presentations.
• Support relationships and scientific interactions with key opinion leaders and external collaborators.
• Contribute to additional neuro-related research activities based on business and project needs.

Desired

Qualifications:

• Master's degree in a relevant scientific discipline required;
  PhD or DVM preferred. Relevant disciplines may include neuroscience, biomedical science, biology, toxicology, materials science, or a related field. Bachelor's degree with significant directly relevant experience may be considered in lieu of an advanced degree. Typically requires:
  Master's degree with 5+ years of relevant industry experience, or PhD or DVM with 3+ years of relevant industry experience, or Bachelor's degree with 10+ years of relevant experience.
• 3-5 years of research experience in neuroscience, tissue histology, or related preclinical research areas. 3-5 years of hands-on experience in preclinical in vivo research, including large animal model testing. 5+ years of experience in medical device R&D with responsibility for biological safety risk assessment, or equivalent depth of experience based on degree level.
• Recognized subject matter expertise in biological safety (ISO 10993) and neuroscience. Strong foundation of internal and external training in area of biological safety.
• Demonstrated ability to present preclinical and scientific data clearly, credibly, and persuasively to expert audiences and key opinion leaders. Ability to communicate complex scientific concepts in a clear, concise, and audience-appropriate manner. Strong written, verbal, and presentation skills, with the ability to respond confidently to scientific…