Biocompatibility QC Scientist

Quality Systems       ·       Fremont, CA       ·       Full time

Neuralink is seeking candidates with a record of outstanding technical achievement and experience in the area of Biocompatibility and Sterility Assurance. In this role you will work with teams across the Neuralink organization to ensure that that device manufacturing complies with relevant regulations around toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety of our products in accordance with applicable global regulatory guidelines. Successful candidates will be highly adaptable, detail-oriented, effective communicators, and have a keen sense of urgency. This position requires good understanding of and/or hands-on experience with principles, regulations, and standards for biocompatibility evaluation of FDA/ISO regulated products, and an experience working in a cross-functional environment. This is a role for someone who comes up to speed quickly and thrives in working at pace. In this role, you will work closely with engineers and quality to assist the successful and smooth completion of biocompatibility evaluation such focusing on patient safety and regulatory approval.

About you:

• You have a meticulous attention to detail with a propensity for efficient workflows.
• You will thrive in a fast paced environment. 
• You know how to examine problems from a first principles approach. 
• You are innovative but realistic. 
• You are optimistic, enthusiastic, and solution-focused. 
• You are comfortable with the ability to work under tight deadlines with some level of ambiguity. 

Responsibilities

• Deliver biocompatibility assessments and biocompatibility evaluation plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.
• Collaborate with a cross-functional team to support multiple projects requiring biocompatibility evaluation ensuring timely completion of required tasks to meet project schedules.
• Analyze biocompatibility test results to determine adequacy of data to meet requirements for the biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected results.
• Assist with regulatory submissions to global regulatory agencies in order to elaborate on the product biocompatibility strategy and data in response to additional information requests.
• Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports.
• Learn and maintain a working knowledge of applicable external standards and industry requirements for the biological safety of medical devices.
• Perform and assist gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on products and business.

Key Qualifications:

• A minimum of a Bachelor’s degree with a discipline in Toxicology, Chemistry, Biochemistry, Biomedical Engineering, Bioengineering, or equivalent science/engineering degree.
• Have 1-3 years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations.
• Understanding of FDA and ISO 10993 biological safety and sterility requirements and/or test methods.
• Understanding of Gap Assessments and Risk Assessments.
• Working knowledge of Good Laboratory and Good Manufacturing practices (GLP and GMP).
• Proficiency with google drive.
• Excellent written and verbal communication skills.
• Planning and organizational skills to prioritize and handle multiple tasks.
• Attention to detail necessary to maintain the required documentation.
• Liaising with contractors and external suppliers.
• Highly motivated self-starter; be proactive and creative in solving technical problems.

What we offer:

• An opportunity to change the world and work with some of the smartest and the most talented experts from different fields. 
• Growth potential. We rapidly advance team members who have an outsized impact. 
• Excellent medical, dental, and vision insurance through a PPO plan; parental leave.
• Flexible time off + paid holidays.
• Equity + 401(k) plan.
• Commuter Benefits.
• Meals provided.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.  This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.