Prin Scientist at Medtronic in North Haven, Connecticut

Job Description:

Careers that Change Lives MITG The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
A Day in the Life
This position has the responsibility and authority to provide 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, Notified Bodies, and Contract Research Organizations.

POSITION RESPONSIBILITIES:

• Designates and manages responsibilities within the scope of inter-departmental projects involving product development, sustainability, and crisis management.
  
  
  • Defines biocompatibility requirements within complex projects and organizes their completion through personal efforts and engaging colleagues, as explained below.
  
  
• Provides technical expertise/guidance to toxicologists, engineers, regulatory affairs specialists, and other personnel to improve efficiency of product time-to-market.
  
  
  • Communicates with relevant stakeholders to optimize device design and evaluate biocompatibility within an acceptable budget and timeline.
  
  
• Develops biological safety evaluation strategies implementing a tiered risk-based approach to establish ISO 10993 compliance in support of new product development and registration.
  
  
  • Coordinates biocompatibility testing with Medtronic Core Technologies Group, Medtronic Physiological Research Laboratory, or Contract Research Organizations, and documents biological assessments using sound scientific principles.
  
  
• Plays an integral role in the Quality Management System to meet quality goals of the business unit.
  
  
  • Exhibits pro-active behavior and organizes meetings to maintain high product quality standards for all medical devices.
  
  
• Ensures the lifecycle biocompatibility of all medical devices.
  
  
  • Plans and manages the impact assessment of manufacturing, supplier, and material changes to medical devices with patient contacting components to ensure biological safety and product sustainability.
  
  
• Evaluates the biological safety impact of device field issues.
  
  
  • Manages communications with departments to address crises, complaints, CAPAs, and HHEs/IIAs stemming from medical device failures/complications occurring in the field.
  
  
• Remains up-to-date with changes in technology, standards, and regulatory policy pertaining to toxicology/biocompatibility.
  
  
  • Informs and educates colleagues on the business impact of such changes, and devises time/money-saving strategies to implement new approaches and address new regulations.
  
  
• Functions as a subject matter expert in toxicology/biocompatibility.
  
  
  • Provides expertise to address questions from regulatory bodies during Medtronic facility audits (i.e., assist Compliance), and conducts site visit audits of Contract Research Organizations.
  
  
• Publishes and presents research as a representative of Medtronic.
  
  
  • Designs and drafts manuscripts for publication that support the biocompatibility, labeling, and registration of medical devices.
  • Attends and presents research at scientific conferences and forums to influence regulatory policy in favor of Medtronic.
  
  
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned.
• Travel requirement: Less than 10%

Must Have: Minimum Requirements

• Bachelor's Degree in Engineering, Science or technical field with 7+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality
• Bachelor's degree in Toxicology, Biology, Chemistry, or related science.

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

• In-depth knowledge of human physiology, biochemistry, and organ systems toxicology.
  
  
  • Must 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.
  
  
• Knowledge of applicable ASTM, ISO, FDA, and EN standards as well as regulatory policies/guidance documents.
  
  
  • An in-depth understanding of ISO 10993 biocompatibility standards; knowledge of ISO 18652 and 22442 standards.
  • Knowledge 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).
  
  
• Proficiency in conducting quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.
  
  
  • Knowledge of the risk assessment paradigm (i.e., hazard identification, exposure assessment, dose-response assessment, and risk characterization).
  • Self-sufficient in conducting scientific literature searches, extracting toxicity data, deriving tolerable exposure limits, as well as calculating margins-of-safety, hazard quotients, and hazard indices.
  
  

• PhD degree in Toxicology or related discipline preferred.
• Expertise 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.
  
  
  • Proficient 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 environment.
  
  
• Strong problem solving and analytical skills.
  
  
  • An independent creative/critical thinker with strategic planning/foresight and decision making abilities.
  
  
• Able to apply new scientific technology and approaches.
  
  
  • Involved in continuous education that is incorporated into the work environment. Willing to continuously improve processes for assessing the biocompatibility of medical devices.
  
  
• Excellent written communication and oral presentation skills.
  
  
  • Exhibits 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.
  
  
  • Functions 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 setting.
  
  
• Computer proficiency with product lifecycle management, word processing, spreadsheet, and analytical software is required.
  
  
  • Product lifecycle management software (Arena PLM, Agile PLM, SAP PLM, etc.)
  • Microsoft Office (Word, Excel, PowerPoint, Outlook, Visio, etc.)
  • Graphing and statistical analysis programs (GraphPad Prism, etc.)
  • Quantitative structure activity-relationship models (DEREK, OECD Toolbox, ToxTree, etc.)
  • Metabolite prediction programs (Meteor Nexus, Metaprint2D-React, etc.)
  • Physiologically-Based Pharmacokinetic (PBPK) models
  
  

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)

Additional Information

• Posting Date: Nov 20, 2020
• Travel: No