Senior Engineer – Design Quality Assurance

Working

Location:

MASSACHUSETTS, WESTBOROUGH
Workplace Flexibility:
Hybrid

The Design Quality Assurance Engineer is responsible for the design, development and management of new products under development. The Product Quality Engineer provides organizational support with a focus on Design Quality activities. Works with internal/external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations. The Product Quality Engineer will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.

• Drive the design & execution of Production Release Process project for components & finished devices.
• Lead and implement complex projects including quality improvement initiatives.
• Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Lead Process/Design Risk Analysis.
• Lead multiple product Design Control activities for new product development efforts.
• Provide leadership in understanding of the quality regulations to other disciplines.
• Lead multiple product Design Control activities for new product development efforts.
• Support Process/Design Validation/Verification activities and approach including software validation.
• Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting.
• Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing.
• Know and follow all laws and policies that apply to one’s job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Required:

• Bachelor’s Degree in Engineering required.
• Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
• Up to 10% domestic travel.

Preferred:

• Strong working knowledge of technical problem solving via Six Sigma type tools to analyze, drive root cause, and solve problems.
• Proven track record in Sustaining Engineering, support of commercialized products and Post Market Surveillance.
• Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
• Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR’s, ISO 13485, ISO 14971, ISO 11135, EUMDR and Human Factors.
• Strong written and oral communication skills.
• Ability to thrive in a fast‑paced, dynamic and deadline‑driven environment.
• Well organized, flexible self‑starter, team motivated and excellent at prioritizing and multi‑tasking.
• Skilled in presentation development and public speaking.

We offer a holistic employee experience supporting personal and professional well‑being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on:
Competitive salaries, annual bonus and 401(k)
* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on‑demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance
* 12 Paid Holidays On‑Site Child Daycare, Café, Fitness Center
** Connected Culture you can embrace:
Work‑life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance
* US Only
** Center Valley, PA and Westborough, MA

The anticipated base pay range for this full‑time position in this location is $98,056.00 – $ / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position,…