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Sr Biocompatibility Scientist at Medtronic in Santa Ana, California

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

Careers That Change Lives

In this exciting role as a Sr. Scientist you will have responsibility to assure that products and processes are in control and in compliance with corporate, division, and regulatory requirements by performing biocompatibility assessment and studies. In addition, assure that all activities are in compliance with FDA, GMP/GLP, ISO 13485, MDD/EU MDR, ISO 22442, ISO 10993, and other national and international standards.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
CVG
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success. Experience what it's like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.

A Day in the Life

  • Provide technical/biological evaluation and regulatory support to both product development and manufacturing operational areas.


  • Interface with engineers and project teams to establish risk assessment, biological evaluation and testing strategy, sample quantity and preparation and project timelines based on the requirements of ISO 10993-1, FDA or other regulatory agencies.


  • Author, execute, review, and approve protocols, reports, and/or regulatory submissions pertaining to biocompatibility and/or animal origin.


  • Facilitate testing requirements and coordinate with external or internal test laboratories to meet project timelines.


  • Provide objective assessment through critical review, interpretation and analysis of raw data, clinical relevance, toxicological risk assessments and trending.


  • Conduct gap analyses of external standards and impact to process, procedures or products.


  • As necessary, engage in improvement projects to support and improve system and/or process reliability.

    Responsibilities may include the following and other duties may be assigned.



  • Apply critical thinking and scientific principles when interpreting and evaluating test results based on established acceptance criteria, toxicological risk assessments or clinical relevance. Recommend and implement corrective actions or changes where necessary.


  • May be involved directly with regulatory agencies.


  • May also be involved in establishing requirements for the transfer of methodology from Research & Development

  • Responsible for the initiation, design, development, execution, and implementation of scientific research projects.

  • Investigates the feasibility of applying scientific principles and concepts to potential inventions and products.

  • Plans and executes laboratory research.

  • Maintains substantial knowledge of state-of-the art principles and theories and may contribute to scientific literature and conferences.

  • May participate in development of patent applications.

  • May coordinate interdepartmental activities and research efforts.

    Must Have: Minimum Requirements


    To be considered for this role, please ensure the minimum requirements are evident on your resume


    Bachelor's degree in Science, Biology, or technical field with 4+ years of work experience in biocompatibility and/or animal origin experience OR Advanced degree in Science, Biology, or technical field with 2+ years of work in biocompatibility and/or animal origin.


    Nice to Have



  • Knowledge and experience with International standards in the use of materials of animal origin in medical device (ISO 22442).


  • Knowledge and experience in the application of GLP regulations and Biological Evaluation of Medical Devices (ISO 10993).


  • Knowledge and experience with the unique biocompatibility expectations between different regulatory bodies or agencies (i.e. FDA, EU MDR, PMDA).


  • Experience in Chemical Characterization, Toxicology Assessment, and Risk Assessment.


  • Leadership experience.


  • Project management skills.


  • Strong written and verbal communication skills.

    About Medtronic


    Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


    We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.


    Physical Job Requirements


    The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)


    Less than 10% travel


    Additional Information



    • Posting Date: Nov 25, 2020
    • Travel: Yes, < 25 % of the Time






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