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Principal R&D Engineer - Toxicology and Pre-Clinical

Irvine, CA 92604
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Principal R&D Engineer - Toxicology and Pre-Clinical


Irvine, California, United States

Requisition #:


Post Date:

Oct 06, 2020


This position
has the responsibility and authority toprovide toxicological oversight in the design,
coordination, and communication of biological evaluations of medical devices
and materials for the purposes of registration in the U.S. and foreign
geographies. A profit-driven business mentality with simultaneous
awareness of maintaining quality control and assurance is required. On a
regular basis, this position must communicate with Research Development,
Quality, Project Management, Regulatory Affairs, Clinical Studies, Marketing,
and Business Development to ensure new product development, product
sustainability, and crisis management activities are efficiently organized and
directed to establish and maintain acceptable patient safety risk-benefit
profiles. This position is responsible for implementing state-of-the-art
toxicological approaches within a continuously evolving biological evaluation
program reliant on a risk management paradigm and providing relevant training
to fellow colleagues within/outside of their department when necessary.
This position will also function as a subject matter expert on behalf of
Medtronic during interactions with the FDA and Notified Bodies.


and manages responsibilities within the scope of inter-departmental projects
involving product development, sustainability, and crisis management.

oDefines biocompatibility requirements
within complex projects and organizes their completion through personal efforts
and engaging colleagues, as explained below.

technical expertise/guidance to toxicologists, engineers, regulatory affairs
specialists, and other personnel to improve efficiency of product

oCommunicates with relevant stakeholders
to optimize device design and evaluate biocompatibility within an acceptable
budget and timeline.

biological safety evaluation strategies implementing a tiered risk-based
approach to establish ISO 10993 compliance in support of new product
development and registration.

oCoordinates biocompatibility testing
with approved vendors, and documents biological assessments using sound
scientific principles.

an integral role in the Quality Management System to meet quality goals of the
business unit.

oExhibits pro-active behavior and
organizes meetings to maintain high product quality standards for all medical

the lifecycle biocompatibility of all medical devices.

oPlans and manages the impact assessment
of manufacturing, supplier, and material changes to medical devices with
patient contacting components to ensure biological safety and product

up-to-date with changes in technology, standards, and regulatory policy
pertaining to toxicology/biocompatibility.

oInforms and educates colleagues on the
business impact of such changes, and devises time/money-saving strategies to
implement new approaches and address new regulations.

as a subject matter expert in toxicology/biocompatibility.

oProvides expertise to address questions
from regulatory bodies during Medtronic facility audits (i.e., assist

and presents research as a representative of Medtronic.

oDesigns and drafts manuscripts for
publication that support the biocompatibility, labeling, and registration of
medical devices.

oAttends and presents research at
scientific conferences and forums to influence regulatory policy in favor of



degree in Toxicology, Biology, Chemistry, or related science.


7years of experience with a Bachelors or 5+ years experience with an advanced
degree conducting toxicological risk assessments, designing and performing
toxicological assays, and/or overseeing biological safety assessments.


knowledge of human physiology, biochemistry, and organ systems toxicology.

oMust understand biological responses to
foreign materials in the human body, including absorption, distribution,
metabolism, and excretion (toxicokinetics), particle-mediated toxicity, as well
as the foreign body response.

of applicable ASTM, ISO, FDA, and EN standards as well as regulatory
policies/guidance documents.

oAn in-depth understanding of ISO 10993
biocompatibility standards; knowledge of ISO 18652 and 22442 standards.

oKnowledge of pertinent sections of
REACH, the EU MDD/EU MDR, and Proposition 65 (hazardous substances regulations)
as well as ICH and FDA Guidance Documents (e.g., Threshold of Toxicological
Concern and Use of ISO 10993-1).

in conducting quantitative risk assessments on chemical characterization
profiles as a part of biocompatibility evaluations.

oKnowledge of the risk assessment
paradigm (i.e., hazard identification, exposure assessment, dose-response
assessment, and risk characterization).

oSelf-sufficient in conducting scientific
literature searches, extracting toxicity data, deriving tolerable exposure
limits, as well as calculating margins-of-safety, hazard quotients, and hazard


PhD degree in Toxicology or related
discipline preferred.

in advanced scientific principles involving risk assessment, biochemical
toxicology, organ systems toxicology, pharmacology and physiology, cell and
molecular biology, immunotoxicology, reproductive and developmental toxicology,
genotoxicity and carcinogenesis, neurotoxicity, pulmonary toxicity,
gene-environment interactions, and biostatistics.

Extensive publication and oral
presentation record preferred with peer-reviewed publications and nationally
recognized presentations.

Strong multitasking and
organizational skills.

at scheduling and coordinating events, delegating and managing team
responsibilities, prioritizing and executing assignments, establishing and
meeting deadlines, as well as leading and maintaining productivity in a team

Strong problem solving and
analytical skills.

independent creative/critical thinker with strategic planning/foresight and
decision making abilities.

Able to apply new scientific
technology and approaches.

in continuous education that is incorporated into the work environment. Willing
to continuously improve processes for assessing the biocompatibility of medical

Excellent written communication and
oral presentation skills.

an outgoing character and ability to tailor communication to specific audiences
by making complex ideas and projects understandable while maintaining a
connection to the big picture.

Able to function independently as
well as in a team environment.

as an influential team member capable of motivating others in a
cross-functional team environment to achieve project goals. Teaches and
educates colleagues to improve their skill set and productivity within a corporate

proficiency with product lifecycle management, word processing, spreadsheet,
and analytical software is required.

oProduct lifecycle management software (Agile PLM, etc.)

oMicrosoft Office (Word, Excel,
PowerPoint, Outlook, Visio, etc.)

oGraphing and statistical analysis
programs (GraphPad Prism, etc.)

oQuantitative structure
activity-relationship models (DEREK, OECD Toolbox, ToxTree, etc.)

oMetabolite prediction programs (Meteor
Nexus, Metaprint2D-React, etc.)

oPhysiologically-Based Pharmacokinetic
(PBPK) models

**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. Lets 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)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2020-10-08 Expires: 2021-03-15
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Principal R&D Engineer - Toxicology and Pre-Clinical

Irvine, CA 92604

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