Job Description

The Staff R&D Engineer ia responsible for all aspects of product development acting as a individual contributor, or where applicable, as a Core Team Member. In this role, the Staff R&D Engineer will execute all aspects of product development for Olympus’s Westborough Development Center. In this dynamic role, the Staff R&D Engineer will have the ability to work on a variety of products, supporting multiple Business Units, with successful product launches over time and as project demands warrant. The Staff R&D Engineer will lead or contribute to efforts to define user and product requirements, collaborate with project managers and other Core Team Members on project execution strategy, timelines and costs, lead product design and prototyping efforts, execute product feasibility testing, technical risk reduction planning, design verification and validation testing strategy and testing efforts, lead or contribute to design analysis testing, and ultimately the generation of all design controls documentation in collaboration with external and/or internal development and manufacturing/quality partners. The Staff R&D Engineer is expected to drive design/concept trade-off decisions while taking costs, technical risk, reliability and User Needs into consideration. She / He must fully understand medical device design control requirements, have experience leading technical development efforts, and be effective at communicating advancements and issues to all levels of the organization.

Job Duties

• Provides technical leadership, and/or significant contributions, to product development projects and/or technology development efforts.
• Contributes to all aspects of product development activities and product Design History Files, such as; requirements creation/documentation, ideation / prototyping, design / development documentation, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supports the compilation of documents to enable regulatory submissions.
• Develops engineering solutions, investigates competing technologies, and collaborates with Olympus Patent Attorneys to secure a strong IP portfolio as needed.
• Supports or leads efforts to evaluate and identify design solutions which will meet product/performance requirements, cost targets, and manufacturability requirements.
• Develops product verification and validation testing requirements, authors testing protocols and reports to ensure products meet and/or exceed established specifications.
• Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
• Supports in ensuring product and performance specifications are appropriate and accurate.
• Supports internal and external suppliers and manufacturers as needed. Including external design and/or development partners.
• Supports marketing in the planning and creation of technical brochures, training programs, and technical presentations to customers and the sales force.
• Supports engineering leadership as required.
• All additional duties as directed.

Job Qualification

Required:

• Bachelor’s degree in mechanical engineering or similar.
• Minimum of 9 years of related experience or 8+ years with MS or 5+ with PhD.

Preferred:

• Competency in leading medical device technical development efforts, through all phases of product development, is required.
• Experience developing products through a Phase Gate process as a Core Team member is highly preferred.
• Experience developing disposable medical devices required.
• Experience and or working knowledge of developing capital equipment is desired.
• Extensive working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements, including 820-CFR, ISO-13485, IEC60601, QSR, etc. is required.
• Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc.