Senior Biocompatibility Scientist
Senior Biocompatibility Scientist
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Job Description
About the Role: We are looking for a Senior Biocompatibility Scientist to join our team. In this role you will help assure the biological safety of Gore medical devices by interfacing with product development regulatory and commercial product support teams to facilitate the process of medical device approval by health authorities (e.g. US FDA EU Notified Bodies etc.).
This position offers multiple work arrangements: on-site at our facility in Flagstaff Arizona or Phoenix Arizona hybrid or fully remote work allowedin most locations within the United States depending upon the responsibilities of the role and business needs.
Responsibilities:
- Develop biocompatibility evaluation plans for new Gore medical devices or changes to existing medical devices per ISO 10993-1 standards
Provide biological safety assessments for internal and external product/process/supply changes Assist product teams in determining patient contact classification of medical device components - Assist product teams in preparation ordering and shipping of test samples to contract testing labs including managing communications with the contract labs during the testing process
Receive test reports from contract labs review for accuracy and acceptance criteria and draft Biocompatibility Evaluation Reports summarizing test results for regulatory submissions Address questions from global regulatory bodies pertaining to biocompatibility evaluations of Gore medical devices Represent Gore on AAMI and/or ISO standards committees pertaining to medical device biocompatibility and assist in standards management for biocompatibility standards
Required Qualifications:
- A Doctoral degree in biological sciences or related field (e.g. chemistry biology biomedical engineering) with a minimum of 3 years industry or related experience OR Masters degree in biological sciences or related field with a minimum of 4 years experience in a medical device or related fieldOR Bachelors degree in biological sciences or related field with a minimum of 7 years experience in a medical device or related field
- Strong understanding of ISO 10993 standards and hands-on experience in applying biocompatibility evaluation principles to medical devices
- Self-motivated professional with strong communication skills adept at collaborating effectively with technical regulatory and business stakeholders
- Excellent verbal and written communication skills
- Strong time management skills with proven experience in handling multiple projects meeting deadlines and managing diverse stakeholder expectations
- Collaborative and self-motivated team player
- Ability to work effectively within and between teams in remote or virtual settings
Ability to travel up to 10%
Desired Qualifications:
- A Doctoral degree in biological sciences or related field with a minimum of 3 years experienceMasters degree in biological sciences or related field with a minimum of 4 years experience
- Experience working with contract research organizations (CROs) Good Laboratory Practices (GLPs) medical device product development writing technical documents preferably within a medical device quality system
- Participation in AAMI and/or ISO standard working groups or committees
Remote Working Arrangements arepermitted forAssociates in the continentalUnited States (US) andCanada withappropriate approval and compliancewithGores remote working policies from thecountryin which they are employed.For fully remote roles thefollowing locations are not eligiblefornew fully remote workarrangements: Alaska andHawaii (forall roles) and Rhode Island(forwage/hourly roles only).
What We Offer: Our success is based on the capability and creativity of our Associates and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for profit-sharing. Learn more at believe in the strength of a diverse and inclusive workplace. With diverse perspectives ideas and experiences we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race color religion sex gender national origin ancestry age status as a qualified individual with a disability genetic information pregnancy status medical condition marital status sexual orientation status as a covered veteran gender identity and expression and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories e.g. arrest and conviction records in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.
Our Talent Acquisition Team welcomes your questions at Experience:
Senior IC
Employment Type
Full Time
Key Skills
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