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Post Market Surveillance Engineer II at Olympus

Post Market Surveillance Engineer II

Olympus Center Valley, PA Full-Time
Working Location: MASSACHUSETTS, WESTBOROUGH; CALIFORNIA, SAN JOSE; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY; TENNESSEE, BARTLETT

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 Engineer, Post Market Surveillance II provides engineering support for PMS system for assessing the following data sources on OSTA products: adverse events (AEs) complaints product feedback customer requirements and market needs patient follow-up after clinical trials/investigations service reports scientific papers in peer-reviewed journals reports on similar products by competitors compliance related communications from regulatory agencies and changes to relevant standards and regulations.

Job Duties

* Responsible for composing and delivering comprehensive reports to the cross-functional management team for early notification and identification of product safety risks and rapid response to emerging issues related to patient safety.
* Perform post market safety surveillance activities including trend analysis signal assessments emerging issue determination and product investigations.
* Execute post market safety surveillance procedures in order to detect potential safety signals.
* Interface with cross-functional team members including product development medical affairs regulatory affairs operations marketing and quality departments to ensure thorough data analysis.
* Maintain a systematic post-market safety surveillance schedule across multiple product families to ensure execution of the Post Market Surveillance process.
* Lead recurring review meetings with cross-functional teams and initiating discussions around potential safety signals.
* Function as Project Coordinator on projects assigned by PMS Director to evaluate product risk and potential safety issues.
* Analyze project prior to implementation by benchmarking against completed projects and recommending project procedures. Plan and organize projects for successful implementation.
* Working in a cross-functional team assess serious injuries and malfunctions in support or regulatory agency product surveillance requirements and ensure the timely initiation and completion of HHEs and regulatory filings if applicable.
* Facilitate the collection and review of literature and the internet for potential complaints AE/MDRs and other signals requiring review and analysis. Work with the PMS Director Medical Safety Office and Design Quality to analyze data for required actions.
* Provide technical guidance to the Product Development team; educate members on technical issues associated with assigned projects.
* Validate and document projects file completed packages for use as benchmarks in subsequent projects.

Job Requirements

REQUIRED QUALIFICATIONS

* Bachelor's Degree, preferably in Engineering or an Associate's Degree in Engineering Technology.
* Minimum of 3 years' experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries.

PREFERRED QUALIFICATIONS

* Knowledge of FDA and MDD medical device regulations desirable, including but not limited to: Design Controls, Risk Management, Usability Engineering, and Complaint Handling.
* Knowledge of Oracle Agile and Microsoft Office.
* Must be highly organized and drive project plans per timeline.
* Ability to effectively analyzing data and report data per requested means.
* Effective communication and presentation skills.
* Strong statistical analysis skills.

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 requires all new hires to be "fully vaccinated" against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

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) || Pennsylvania (US-PA) || Center Valley ||

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