Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA,
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
- Subject matter expert for customer and patient focused, end to
end Risk Management.
- Supports complaint investigations, signal detection, product
- Supports facility audits by outside agencies. (i.e., FDA, ISO /
- Other Quality Assurance responsibilities as assigned by
- Bachelor's degree or equivalent in an engineering or life
- Minimum 8 years of professional experience or equivalent
training/education in Quality or other Engineering
- Minimum 5 years working in medical device new product
- MBA or other advanced degree strongly preferred.
- Proven track record in New Product Development delivering on
robust, customer and patient focused product quality, Concept
- 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
- 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
- Must be a change agent, highly and effectively organized, be a
flexible selfstarter, team-oriented and excellent at prioritization
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
OlympusTrue 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
Posting Notes: || United States (US) || Massachusetts (US-MA) ||