Location: Westborough, MA
Company: Olympus
lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View We deliver on our purpose and our core values by staying True to Life. Job Description 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 Job Duties 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 Job Qualifications Required: 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. Preferred: 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 voe 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 I 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 #LI-Onsite Why join Olympus?
Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k) with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center US Only Limited locations We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.
Learn more about our benefit offerings at /careers/benefits-perks. About us: Our 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 costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let’s realize your potential, together. 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, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual 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 Quality & Regulatory Affairs (QA/RA)
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