Abbott

Sr. Biocompatibility Scientist

Abbott • $78K — $156K *
St. Paul, MN 55106In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Yesterday
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Associates Degree or equivalent experience (± 13 years)
  • Minimum 4 years in a relevant role
  • Bachelor's or Master's degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, or related field preferred
  • Experience in Medical Device, Pharmaceutical, or Biotechnology sectors
  • Knowledge of ISO 10993 and biocompatibility regulations
  • Proficient in MS Office Suite
  • Strong verbal/written communication skills and technical writing ability

Responsibilities

  • Develop protocols and regulatory summaries with cross-functional teams
  • Support quality system updates to meet regulatory standards
  • Identify biocompatibility strategies to address material and process gaps
  • Monitor biocompatibility studies for adherence to protocols and GLP
  • Update internal and external guidance documents for biocompatibility compliance
  • Assist in biological hazards risk analysis
  • Interface with internal and external business partners
  • Analyze and interpret biocompatibility testing results
  • Help draft responses to regulatory queries regarding biocompatibility

Benefits

  • Professional development opportunities
  • Collaborative work environment
  • Engagement with cross-functional teams
  • Innovative projects focusing on patient safety
  • Focus on compliance and regulatory knowledge expansion
Full Job Description
JOB DESCRIPTION:

Job Description Summary

We are seeking an experienced, high caliber Scientist II who will make an important contribution to patient safety by supporting projects and programs related to the biocompatibility of medical devices, materials, and processes. This role will be responsible for submitting test devices to laboratories, managing test progress, and serving as the primary contact for the labs. The Scientist II will work closely with cross-functional teams to provide biocompatibility deliverables (biocompatibility plans/reports/justifications) in compliance with global regulatory requirements such as ISO 10993. The role requires comprehensive knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations and guidance affecting assigned devices (Class I to Class III). The candidate must be able to support the biocompatibility team in correctly apply regulatory requirements as appropriate to product development and change activities for assigned devices. The candidate must have strong ability to interpret biological test results and detailed scientific information.

Essential Responsibilities:

  • Develop technically sound protocols, reports, and regulatory summaries in collaboration with cross-functional program teams, test laboratories, and suppliers.


  • Support quality system activities, including updating procedures and templates to ensure compliance with regulatory requirements and continuous improvement initiatives.


  • Understand biocompatibility strategies that address gaps in materials, design and processes to achieve optimal solutions that satisfy cost and technical requirements related to biological safety.


  • Monitor biocompatibility testing activities to ensure that studies are conducted according to the study protocols, SOPs, applicable regulations and the principles of Good Laboratory Practices (GLP).


  • Make positive contributions to and recommend approaches for updating and developing procedures for internal and external guidance documents related to biocompatibility, in compliance with applicable global regulatory requirements (e.g. FDA, ISO, MHLW, and CFDA).


  • Assist the biocompatibility team members in identifying critical process factors and their effects on biological safety.


  • Support biological hazards risk analysis activities.


  • Interface with key business partners internally and externally.


  • Analyze, interpret, and draw conclusions from biocompatibility testing, including, but not limited to, extractable and leachable chemical characterization and biological evaluations.


  • Assist biocompatibility team members in developing strategies and drafting responses to regulatory submission questions related to biocompatibility.


Required Qualifications:

  • Associates Degree ((± 13 years)


  • Minimum 4 years experience


Preferred Qualifications

  • Bachelor's degree in Biomedical Engineering, Molecular/Cell Biology, Biochemistry, Materials Science, Chemistry, Toxicology, or other medical-related disciplines. Master in Science (MS) degree preferred.


  • 3+ years of industrial experience in Medical Device, Pharmaceutical, or Biotechnology fields with expertise in biocompatibility, toxicology, and/or special process validation. A master's degree in a relevant engineering or scientific discipline may substitute for years of industry experience.


  • Fundamental understanding or direct experience with ISO 10993 standards, biomaterials, toxicological risk assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.


  • Proficient with MS Office (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive).


  • Strong verbal and written communication skills, with the ability to effectively communicate at multiple levels within the organization.


  • Strong technical writing skills, with experience in writing biological risk assessments for FDA and Notified Bodies preferred.


  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.


  • Ability to prioritize and meet deadlines in a timely manner.


  • Strong organizational and follow-up skills, with attention to detail.


  • Experience working in a broader enterprise/cross-division business unit model preferred.


  • Ability to work in a highly matrixed and geographically diverse business environment.


The base pay for this position is
$78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Research and Discovery

DIVISION:
MD Medical Devices

LOCATION:
United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
No

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

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Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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