Abbott Senior Manager Biocompatibility in Santa Clara, California
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 107,000 colleagues serve people in more than 160 countries
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ﬁngersticks.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Our location in Santa Clara, CA, currently has an opportunity for a Senior Manager, Biocompatibility
WHAT YOU’LL DO
Responsible for overall technical leadership. Provides guidance for the design and development of company products. Works closely with senior management to establish product development goals while ensuring market compatibility.
Technical leader within the company.
Formulates and implements research and development programs, policies, and procedures required to support profitable growth.
Provides leadership to Biocompatibility team to keep focus.
Work closely with program/project cross-functional teams to provide biocompatibility assessments, strategy and deliverables in compliance with global regulatory requirements such as ISO 10993.
Collaborate and clearly communicate with internal and external stakeholders (e.g., Board Certified Toxicologists and Contract Research Organizations (CROs) to ensure appropriate planning and execution of risk assessments and required testing.
Identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation.
Provides design/development teams with appropriate resources to perform assigned tasks.
Interfaces with appropriate internal and external resources to ensure intellectual property is appropriately protected.
Interfaces with appropriate internal and external resources (regulatory, customers, etc.) to ensure development programs meet regulatory and customer requirements.
Provides technical assistance for diagnosing design and manufacturing quality problems.
Guides development and documentation of test plan protocols, standard operating procedures, specifications and test procedures.
Develops departmental budget estimates.
Contributes to business unit and divisional strategy planning.
Participates in review boards for intellectual property, CAPA, complaints, business unit planning, and others as necessary.
Reviews and provides functional approval for project and quality system documentation.
Develops and manages organizational plans and resources for the specific department and business units for which they are responsible.
Provides mentorship and career development oversight for direct report employees.
Tracks and forecasts divisional and product and technology projects
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION AND EXPERIENCE YOU’LL BRING
The position requires a Master or PhD degree in biology, biochemistry, toxicology, analytical chemistry or materials science, preferably with a specialism relating to medical devices.
The position requires a minimum of 5 years in Biocompatibility for medical devices
Expert in US and global regulations (e.g., EU, China, Korea and Japan) and requirements for biocompatibility and safety testing, particularly ISO 10993
Experience working with global regulations and requirements, especially the EU Medical Device Directives (MDD) and Medical Device Regulations (MDR).
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 30%, including internationally
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
· A fast-paced work environment where your safety is our priority (Manufacturing roles only)
· Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)
· Training and career development, with onboarding programs for new employees and tuition assistance
· Financial security through competitive compensation, incentives and retirement plans
· Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
· Paid time off
· 401(k) retirement savings with a generous company match
· 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: http://www.abbottbenefits.com/pages/candidate.aspx
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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org