Quality Engineer I

$88,209 - $88,209/Yr

Olympus - Westborough, MA

Full-time - Entry Level

Westborough, MA

5,001-10,000 employees

Merchant Wholesalers, Durable Goods

About the position

The Product Quality Engineer I at Olympus plays a crucial role in enhancing medical technologies and ensuring patient safety. This position involves collaboration with various departments to support the lifecycle of medical devices, focusing on new development and risk management. The engineer will contribute to key projects, develop solutions to technical problems, and ensure compliance with applicable standards and regulations.

Responsibilities

• Help to develop solutions to technical problems which require the regular use of ingenuity and creativity.
• Assist in the design and execution of the Product Development Process.
• Collaborate with project teams to define product requirements, support test method development and validation, and support Design Verification planning and reporting.
• Develop, implement, and update risk management deliverables (i.e. hazard analysis, risk considerations, FMEAS, risk management plans and reports, etc.) supporting new product development and sustaining efforts.
• Be involved in the execution of Quality Deliverables such as Project Design & Development Plans and Product Development Quality Plans.
• Support process and design related verification and validation activities.
• Help in the execution of the Risk Management deliverables to ensure compliance to applicable standards and regulations (including EUMDR) and demonstrate a primary commitment to patient safety.
• Be involved in usability and design validation efforts for new product development and design change projects.
• Review and analyze complaint information to identify new failure modes, new harms, and/or trends.
• Work cross-functionally with project management, R&D, regulatory, manufacturing, and other quality functions.

Requirements

• BS in Mechanical, Electrical, or Biomedical Engineering
• Demonstrated ability to balance academic and extracurricular commitments (i.e. work experience, clubs, volunteer activities, teams, etc.)
• Must possess excellent analytical and organizational skills
• Must be proficient and have practical knowledge in Microsoft Word, Excel, and PowerPoint
• Must be able to work well within a team and independently at times with limited guidance
• Up to 10% domestic travel

Nice-to-haves

• Internship with a Medical Device company preferred but not essential
• Ability to thrive in a fast-paced, dynamic and deadline-driven environment
• Self-motivated with the ability to prioritize/execute multiple concurrent tasks
• Strong, professional communication skills
• Skilled in presentation development and public speaking
• General curiosity and a desire to learn new material

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