Biomedical Engineer II/Biocompatibility (Northridge, CA)

Medtronic • Northridge, CA

82d • $80,000 - $120,000

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This position involves performing chemical characterization in alignment with biocompatibility assessments, organizing and coordinating required testing, and preparing clear, concise, and well-structured test plans and reports to support regulatory submissions. This role involves coordinating required chemical characterization testing, and authoring clear, concise, and well-structured reports to support regulatory submissions. This position involves close collaboration with multidisciplinary and cross-functional teams to ensure compliance with ISO 10993 standards and global medical device regulations. The role also supports product development by designing and executing design verification test methods and conducting statistical data analysis to assess product performance and functionality. The candidate is expected to contribute to scientific presentations and author relevant technical publications as needed. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

Requirements

• Requires a Bachelors degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Nice To Haves

• BS in science, medical technology, or related fields. MS or PhD preferred.
• Strong skills in design of experiments, data analysis, written and verbal communications, and collaboration.
• Critical thinking skills to interpret available data and recommend strategies to resolve technical challenges.
• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
• Author, execute, review, and approve protocols, reports, and/or regulatory submissions pertaining to chemical characterization per ISO 10993-12, 17 and 18.
• Provide objective assessment through critical review, interpretation and analysis of raw data, clinical relevance, toxicological risk assessments and trending.
• Root cause(s) and efficient recommendations for resolution.
• Must be self-motivated and able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced environment.

Responsibilities

• Perform chemical characterization in alignment with biocompatibility assessments, organizing and coordinating required testing, and preparing clear, concise, and well-structured test plans and reports to support regulatory submissions.
• Provide technical documentation supporting biological assessments of material and device safety in accordance with ISO 10993-1 by conducting chemical characterization analysis impact assessments for changes in materials, processes, or intended uses of devices.
• Coordinate and oversee chemical characterization testing with external laboratories, and analyze test results to ensure regulatory compliance.
• Perform technical feasibility and design verification activities in a product development environment, including chemical characterization analysis, toxicological risk assessments, materials of concern (MOC) in collaboration with department staff and contract laboratories.
• Interpret chemical characterization data to integrate into the Biological Evaluation Report (BER), preparing devices for submission to internal and external laboratories, maintaining good documentation practices, and ensuring accurate records of original information.

Benefits

• Competitive Salary and flexible Benefits Package.
• Health, Dental and vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance/reimbursement.
• Simple Steps (global well-being program).
• Incentive plans.
• 401(k) plan plus employer contribution and match.
• Short-term disability.
• Paid time off.
• Paid holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums).
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees