Olympus Corporation of the Americas Post Market Surveillance Engineer I in Westborough, Massachusetts
Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY; TENNESSEE, BARTLETT
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Provide 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.
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.
Support the implementation of new process / procedures to align with changing global medical device regulations.
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.
Validate and document projects file completed packages for use as benchmarks in subsequent projects.
Perform all other related duties as assigned.
* Requires a Bachelors Degree in Engineering or an Associate's Degree in Engineering Technology.
- Minimum of 0 – 2 years experience. Internship in regulated business environment, preferably in the medical device or pharmaceutical business.
* Internship in a Post-Market Surveillance capacity highly desired.
Possess a high degree of self reliance initiative creativity and personal organization.
Undergraduate studies with exposure to FDA design controls and the product development process with knowledge of risk management activities.
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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 .
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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) || Massachusetts (US-MA) || Westborough ||
Olympus Corporation of the Americas
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