Staff R&D Engineer

Olympus - Westborough, MA

Full-time - Mid Level

Westborough, MA

5,001-10,000 employees

Merchant Wholesalers, Durable Goods

About the position

The Staff R&D Engineer at Olympus is responsible for leading and executing all aspects of product development within the Westborough Development Center. This role involves collaborating with cross-functional teams to define user and product requirements, manage project execution strategies, and ensure successful product launches. The engineer will also be responsible for design and prototyping, feasibility testing, and compliance with medical device regulations, while driving design decisions that balance cost, technical risk, and user needs.

Responsibilities

• Provide technical leadership on product development and technology development efforts.
• Develop detailed product development strategies while considering the interests of all Core Team Members.
• Utilize the Core Team Model and stage gate development processes for product development.
• Provide technical updates to R&D management and Core Team Members through regular discussions and updates.
• Prioritize and organize work based on project priorities.
• Develop User and Product Requirements.
• Plan Design Verification and Validation efforts to meet all requirements and standards.
• Communicate effectively with Core Team and Extended Team Members to ensure high-quality deliverables.
• Collaborate on the technical development schedule and monitor progress with the Project Manager.
• Accountable for all aspects of product development activities and associated deliverables, including design inputs and compliance with regulations.
• Conduct robust design analysis and risk analysis to ensure performance and quality.
• Ideate product designs and collaborate with manufacturing partners to ensure manufacturability.
• Lead technical risk reduction activities and contingency planning.
• Consult with marketing and clinicians to ensure appropriate design decisions.
• Manage and support suppliers involved in product development and production.
• Assist marketing with technical brochures, training programs, and presentations to customers.

Requirements

• Bachelor's degree in Mechanical Engineering or similar field.
• Minimum of 9 years of related experience with a BS, 8 years with an MS, or 5 years with a PhD.
• Competency in leading medical device technical development efforts through all phases of product development.
• Experience developing disposable medical devices.
• Extensive knowledge of FDA and international requirements, including 820-CFR, ISO-13485, IEC60601, QSR, etc.
• Proficient in Microsoft Windows Office applications including MS Outlook, MS PowerPoint, MS Project, Visio, etc.
• Ability to create and critically review engineering drawings, including dimensioning and tolerancing strategies.
• Knowledge of common manufacturing methods and experience with medical device polymers.
• Strong problem-solving skills and ability to provide guidance to other engineers.
• Ability to make timely decisions balancing risk vs. benefits.
• Experience in planning robust design assurance testing and implementing contingency plans.
• Working knowledge of statistical analysis packages, preferably Minitab.

Nice-to-haves

• Experience developing products through a Phase Gate process as a Core Team member.
• Experience with capital equipment development.
• Self-motivated and productive.
• Ability to collaborate effectively within cross-functional teams.
• Strong communication skills at all levels, both verbally and in writing.
• Ability to inspire and motivate others.

Benefits

• Competitive salaries, annual bonus, and 401(k) with company match.
• Comprehensive medical, dental, and 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.