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 109,000 colleagues serve people in more than 160 countries.
A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Our location in Sylmar, (CA), OR remote currently has an opportunity for a Staff, Biological assessment.
Individual contributor responsible for serving as an SME in biocompatibility and focuses on the toxicological and biocompatibility evaluation of products and technologies required for product approvals and patient safety of Abbott medical devices in accordance with applicable global regulatory guidelines.
WHAT YOU’LL DO
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Deliver biocompatibility assessments and biocompatibility evaluation plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.
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Collaborate with a cross-functional team to support multiple projects requiring biocompatibility evaluation ensuring timely completion of required tasks to meet project schedules.
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Analyze biocompatibility test results to determine adequacy of data to meet requirements for the biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected results.
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Assist with regulatory submissions to global regulatory agencies in order to elaborate on the biocompatibility strategy and data in response to additional information requests.
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Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports.
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Learn and maintain a working knowledge of applicable external standards and industry requirements for the biological safety of medical devices.
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Perform and assist gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on Abbott medical devices and business.
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Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
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Plans and organizes project assignments of substantial variety and complexity.
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Initiates or maintains schedule for projects and project milestones.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
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Bachelors Degree in biology, biochemistry, toxicology, molecular cell biology, immunology or relevant engineering or scientific discipline.
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Minimum 9 years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations with a focus in medical devices.
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Good understanding of and experience of applying the principles, theories, and concepts in biocompatibility per ISO 10993
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Extensive experience in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
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Experience working in Design Control environment
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Demonstrated track record of innovative scientific accomplishments, approved patents and breakthrough technical contributions. Outstanding technical leadership skills.
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Ability to work in a highly matrixed and geographically diverse business environment.
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Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
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Ability to leverage and/or engage others to accomplish projects.
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Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
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Multitasks, prioritizes and meets deadlines in timely manner.
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Strong organizational and follow-up skills, as well as attention to detail.
Preferred
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Masters Degree or PhD in relevant engineering or scientific discipline with a specialism relating to medical devices.
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Experience with biomaterials, toxicological assessments, E & L analysis for materials, container-closure systems, processes for medical device manufacturing, and biocompatibility assessment is a strong plus.
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Experience working in a broader enterprise/cross-division business unit model preferred.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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Training and career development, with onboarding programs for new employees and tuition assistance
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Financial security through competitive compensation, incentives and retirement plans
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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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Paid time off
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401(k) retirement savings with a generous company match
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The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.