Senior Quality Engineer, NPD

Working Location: Massachusetts, Westborough; Nationwide Workplace Flexibility: Hybrid

About the role

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy.

Responsibilities

• Drive the design & execution of Production Release Process project for components & finished devices.
• Lead and implement complex projects including quality improvement initiatives.
• Set direction for cross-functional teams and drive towards compliant and efficient solutions to complex problems.
• Lead Process/Design Risk Analysis.
• 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.

Requirements

• Bachelor’s Degree in Engineering required.
• Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
• Strong working knowledge of technical problem solving via Six Sigma type tools to analyse, drive root cause, and solve problems.
• Proven track record in NPD 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.
• Up to 10% domestic travel.

Benefits

• 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

Pay

The anticipated base pay range for this full-time position in this location is $95,904.00 - $129,470.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

Schedule

Hybrid work environment