Olympus Corporation of the Americas Principal Design Quality Engineer in Westborough, Massachusetts
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.
The Principal Design Assurance Engineer will focus on Product Quality by contributing to new product development, sustaining engineering, risk management and end to end product quality.
Core Team Member supporting new product development and sustaining engineering projects across multiple sites
Act as a coach and mentor in the Quality Engineering team and cross-functionally to build and develop skills and competencies of others
Subject matter expert for customer and patient focused, end to end Risk Management
Supports complaint investigations, signal detection, product issue escalations
Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP)
Other Quality Assurance responsibilities as assigned by Management
Bachelor's degree or equivalent in an engineering or life science discipline
Master of Business Administration or other advanced degree strongly preferred
Minimum of 8 years of professional experience or equivalent training/education in Quality or other Engineering disciplines.
Minimum of 5 years working in medical device new product development
Proven track record in New Product Development delivering on robust, customer and patient focused product quality, Concept through Post-Launch
Strong technical skills related to product quality including VOC translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization,Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics
Strong working knowledge of FDA QSR’s, MDSAP, ISO 13485, Design Controls, Human Factors and Risk Management practices
Strong working knowledge of technical problem solving skills. Design or Process Green / Black Belt is a plus
Strong collaboration skills and the ability to work across functions
Must be a change agent, highly and effectively organized, be a flexible self‑starter, team-oriented and excellent at prioritization and multitasking
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) || Westborough ||
Olympus Corporation of the Americas
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