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Toxicologist Engineer

Req ID:  1888

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Toxicologist Engineer provides strategic leadership for OSTA in the execution of the Toxicology, Biocompatibility and Chemical Characterization of medical devices to ensure compliance is maintained with Regulatory requirements along with the business strategy of the company. They serve as the Subject matter expert in toxicology and biocompatibility providing expertise, training and mentoring to the organization in toxicology and biocompatibility and supports new product development, manufacturing, returns and servicing of products produced by OSTA.

Job Duties

* Maintain repsonsibility for supporting new product development, manufacturing and regulatory from a toxicological and biocompatibility perspective.
 

* Maintain repsonsibility for to ensure requirements of the Regulatory requirements for toxicology and biocompatibility are applied and adhered to for the validation of new and existing products.
 

* Ensures that the toxicology and biocompatibility procedures are accurate, reflecting the quality system, all regulatory requirements and ensures that they are implemented correctly.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Masters Degree is required. (PhD preferred)

 

* Minimum of 3 years toxicological experience.


* Medical Device Experience: Minimum of 8-10 years

 

* Toxicology: Minimum of 8-10+ years

 

* Biologics Evaluation Reports (BERs)

 

* Chemical Characterization & Toxicological Risk Assessments 

 

* Analytical Evaluation Threshold (AET)

 

* Threshold of Toxicological Concern (TTC)

 

* Dose-Based Thresholds (DBT)

 

* Extractables & Leachables 

 

* Biocompatibility

 

* Benefit-Risk Assessment

 

* ISO 10993-1:2018

 

* ISO 10993-18:2020(en)

 

* ISO/TS 21726:2019

 

* DABT Board Certified Toxicologist

 

* EU MDR experience

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

 

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || 

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Nearest Major Market: Minneapolis

Job Segment: Manufacturing Engineer, Engineer, Medical Device Engineer, QA, Quality Assurance, Engineering, Technology, Quality

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