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Product Risk Summary Engineer

Req ID:  777

Working Location: MASSACHUSETTS, SOUTHBOROUGH 

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 Product Risk Summary Engineer maintains responsibility for creating, updating and maintaining OSTA Risk Summary Sheets (RSS) and related risk documents to support the Olympus Risk Summary Application (RSA) for consistent and robust complaint handling, signal detection, trending and Adverse Event Reporting. This role will also support RSS Product Quality activities, such as new product development, sustaining product changes/improvements and end to end risk management.  

Job Duties

* Supports complaint investigations and alignment on reportability decisions via the RSS tool.

 

* Create, update and maintain OSTA Risk Summary Sheets and related risk documents for a closed loop risk management process.

 

* Working knowledge of statistical methods (e.g., trending, control charting, hypothesis testing, power and sample size determinations, etc.).

 

* Demonstrated project management skills and interact and collaborate with cross-functional teams.

 

* Strong knowledge of Risk Management and risk assessment tools (e.g., ISO 14971, FMEA’s, FTA).

 

* Strong knowledge of Quality Engineering principles and methodologies including - Design and Process Controls, Quality Systems and Compliance.

 

* Support audits and assessments as the OSTA RSSM and RSS Subject Matter Expert.

 

* Perform other related duties as assigned by management.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree or equivalent in an engineering or life science discipline.

 

* Minimum 3 years of experience in Quality with an emphasis in Quality Engineering and Risk Management within an FDA regulated medical device manufacturing environment.

 

* Strong written and oral communication skills are required.

 

PREFERRED QUALIFICATIONS:

 

* Knowledge with DMAIC / Black Belt / Six Sigma type tools to analyse, drive root cause, and solve problems. Green Belt or Black Belt Certification is preferred.

 

* Strong working knowledge of statistics and trending - including statistical software and tools such as Minitab and Power BI.

 

* Must be self-motivated with a strong sense of urgency.

 

* Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM. 

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) || Massachusetts (US-MA) || Southborough || 

 

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Nearest Major Market: Worcester

Job Segment: Medical Device Engineer, Manufacturing Engineer, Engineer, Quality Engineer, Engineering, Quality

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