Staff Biocompatibility Scientist
Staff Biocompatibility Scientist
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$ 97300 - 194700
1 Vacancy
Job Description
JOB DESCRIPTION:
Staff Biocompatibility Scientist
As a Staff Biocompatibility Scientist you will play a pivotal role in safeguarding patient health by leading biocompatibility initiatives for medical devices materials and processes. Acting as a Subject Matter Expert (SME) within the Global Biocompatibility Group you will collaborate with cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements such as ISO 10993.
You will apply your deep expertise in biocompatibility throughout the product lifecycle supporting Class II and III medical devices. This includes interpreting regulatory requirements guiding strategy development and critically evaluating scientific data to identify risks and recommend mitigation strategies.
Key Responsibilities:
Author review and approve biocompatibility assessments evaluation plans and reports in alignment with ISO 10993 and FDA guidance.
Partner with cross-functional teams to support multiple projects ensuring timely and compliant biocompatibility deliverables.
Analyze test results for biological effects troubleshoot anomalies and provide technical guidance. Evaluate research findings and recommend future research directions.
Support global regulatory submissions by articulating biocompatibility strategies and responding to agency inquiries (e.g. FDA PMDA EU and NMPA).
Stay current with evolving biological safety standards and regulations and conduct gap analyses to identify and mitigate potential product and business risks.
Required Qualifications:
Bachelors Degree ( 16 years) B. S in biological or physical sciences or mathematics; with 10 years of progressively responsible positions in a research development environment OR Doctorate Degree ( 19 years) PhD with 4 years of experience
Minimum 4 years with PhD- Execution of practical lab skills with increasing complexity of knowledge with experience. Demonstrates knowledge of science and the ability to apply more complex and advanced principles and techniques with experience.Expert level (able to explain and teach) experimental approaches/protocols and scientific methods such as designing experiments and interpreting data. Application/understanding of regulations and standards affecting IVDs and to provide implementation of regulations into the technical decisions. Basic computer skills - able to learn new computer programs
Minimum 10 years with BA/BS - Execution of practical lab skills with increasing complexity of knowledge with experience. Demonstrates knowledge of science and the ability to apply more complex and advanced principles and techniques with experience.Expert level (able to explain and teach) experimental approaches/protocols and scientific methods such as designing experiments and interpreting data. Application/understanding of regulations and standards affecting IVDs and to provide implementation of regulations into the technical decisions. Basic computer skills - able to learn new computer programs
Preferred Qualifications:
Ph.D. with a minimum of 5 years or masters degree with minimum of 7 years or bachelors degree* with minimum of 10 years of industry experience in medical devices pharmaceuticals or biotechnology with a focus on biocompatibility or biological safety assessments.
Proficiency in MS Office Suite (Word Excel Outlook PowerPoint SharePoint OneDrive) and Adobe pdf.
In-depth knowledge of ISO 10993 biomaterials toxicological risk assessment extractables and leachables biocompatibility methodologies and medical device manufacturing processes.
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.
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
The base pay for this position is
$97300.00 $194700.00In 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:
United States > Burlington: 23 Fourth Avenue United States > Pleasanton : 6101 Stoneridge Dr United States > Santa Clara : Building B - SC United States > Sylmar : 15900 Valley View Court United States > Temecula : Building B - TB United States > Texas > Plano : 6600 Pinecrest United States > Westfield: 1820 Bastian Court
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
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)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:
Staff IC
Employment Type
Full-Time
Key Skills
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