Biocompatibility Manager â Medical Devices (on-site)
Biocompatibility Manager â Medical Devices (on-site)
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$ 128000 - 256000
1 Vacancy
Job Description
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. Youll 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 bachelors 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 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine ngersticks.
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 Youll 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.)
PreferredQualifications
- Bachelors degree in one or more of the following or related disciplines: Biomedical Engineering Bioengineering Biology (Biological Sciences) Molecular Cell Biology Biochemistry Materials Science or Toxicology; advanced degree (MS or PhD) preferred although comparable areas of study and industry experience is considered for the position
- Minimum 5 years industrial experience in the field of Medical Device Pharmaceutical or Biotechnology with expertise in biocompatibility and/or toxicology
- Deep fundamental understanding or direct experience of the ISO 10993 standards biomaterials toxicological assessment extractable and leachable analysis medical device manufacturing processes and biocompatibility assessment methodology
- Demonstrated ability to draw conclusions present and make recommendations based on technical inputs from multiple and varied functions
- Ability to leverage and/or engage others to accomplish project deliverables.
- Excellent communication skills both verbal and written and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site and multi-business unit
- Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer committed to employee diversity.
Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$128000.00 $256000.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Research and Discovery
DIVISION:
MD Medical Devices
LOCATION:
United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:
United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B United States > Santa Clara : Building A - SC
WORK SHIFT:
Standard
TRAVEL:
Yes 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder bent wrists) Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Manager
Employment Type
Full-Time
Key Skills
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