Biocompatibility Manager – Medical Devices (on-site)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Opportunity

We are seeking an experienced, high caliber Biocompatibility Manager located on-site in either St. Paul, MN or Santa Clara, CA.  This new team member will make an important contribution to patient safety by supporting projects/programs in terms of biocompatibility of medical devices, materials, and processes. The manager will represent our business unit(s) Biocompatibility Team as a Subject Matter Expert (SME) in biocompatibility and will work closely with program/project cross-functional teams to provide biocompatibility strategy and deliverables in compliance with global regulatory requirements such as ISO 10993. Additionally, this role requires knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidance that affect assigned devices (Class I to Class III). This individual must have strong ability to interpret biocompatibility regulatory requirements and guidance and apply regulatory requirements as appropriate to product development and change activities for assigned devices. The Biocompatibility Manager must have strong ability to critically review detailed scientific information and assess any gaps based on adequately supported data and be able to identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation.

What You’ll Work On

• Provide leadership and technical guidance to your Biocompatibility Team
• Work closely with internal and external stakeholders to provide biocompatibility assessments, strategy, and deliverables in compliance with global regulatory requirements such as ISO 10993 and FDA requirements
• Collaborate and clearly communicate with internal and external stakeholders (e.g. Contract Research Organizations, R&D, Regulatory) to ensure appropriate strategy, planning and execution of risk assessments, required testing and other deliverables.
• Guides development and documentation of test plan protocols, reports, standard operating procedures, and specifications.
• Develop and deliver regulatory submission and responses to biocompatibility related questions
• Influence organization excellence by recommending approaches, procedures, and work aids as they relate to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA)
• Develop departmental budget estimates and contribute to the Global Biocompatibility Organization and Business Unit strategy planning

Required Qualifications

• Ph.D. plus 6 years’ experience or B.S./M.S. with equivalency*; proven track record of research which advances technology within the division. (*Equivalency to Ph.D. defined as ability to hypothesize, design own experiments, draw conclusions, and provide direction.)     

Preferred Qualifications