Staff R&D Engineer

Job Description

The Staff R&D Engineer is responsible for all aspects of product development acting as an 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 on product development and/or technology development efforts.
• Envisions, collaborates/communicates, and documents detailed product development strategies while mindful of the interests of all Core Team Members.
• Experienced in developing products utilizing the Core Team Model and skilled with  stage gate development processes
• Experienced in providing technical updates to R&D manager, and/or to an R&D Core Team Member, through weekly discussions and monthly updates.
• Capable of prioritizing and organizing work/efforts based on project priorities.
• Experienced in developing User and Product Requirements.
• Experienced in planning Design Verification and Validation efforts to ensure the product effectively meets all requirements and applicable standards.
• Capable of effectively communicating with Core Team and Extended Team Members, while ensuring all R&D deliverables are completed with a high degree of quality, and attention to detail.
• Collaborates on the development of the technical development schedule and monitors advancement in collaboration with the Project Manager.   Reports advancement to Core Team and to R&D Leadership.
• Accountable for all aspects of product development activities and associated deliverables, such as: Design Inputs, specification development, ideation / prototyping and feasibility testing, technical risk mitigation, verification and validation, phase specific readiness review, design reviews, compliance to applicable regulations and standards, compliance to Corporate Product Branding, etc.
• Experienced in robust design analysis, such as tolerance stack-ups, edge of failure testing, high/low specification evaluations, risk analysis, and statistical evaluations as necessary to ensure performance and quality.
• Capable of ideating product designs, and collaborating with manufacturing partners and suppliers, to ensure designs are cost effective and manufacturable.
• Proactively ideates and leads technical risk reduction activities and contingency planning.
• Consults with the Marketing core team member and clinicians to ensure a thorough understanding of the procedure, products use, and environmental factors to ensure appropriate design decisions.
• Manages, directs, and supports suppliers involved in product development and ongoing production; including external design and development partners.
• Helps prepare, and acts as a consultant to, marketing on technical brochures, training programs, and technical presentations to customers and the sales force
• Documents innovations in partnership with Olympus Patent Attorneys

Job Qualifications

Required:

• Bachelor’s degree in Mechanical Engineering or similar 
• Minimum years of related experience: 9 years with BS, or 8 years with MS, or 5 with PhD
• Competency in leading medical device technical development efforts, through all phases of product development, is required.
• Experience developing disposable medical devices required.
• 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..
• Proficient in the creation and critical review of engineering drawings, including the ability to critique dimensioning and tolerancing strategies, is required.  Working knowledge of Solidworks is a plus.
• Knowledge of common manufacturing methods, such as; injection molding and molded part design, extrusion, adhesives, ultrasonic welding, etc., as well as experience designing/developing products employing common medical device polymers is required.
• Must be able to solve complex and/or ambiguous problems using good judgement as well as logical and systematic thinking.  Capable of providing problem solving guidance to other engineers.
• Must be able to use good judgement in making timely decisions. Able to balance risk vs. benefits in a variety of situations. 
• Must be able to envision design failure modes, plan for robust design assurance testing, and proactively implement contingency plans as necessary.
• Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab is preferred).

Preferred:

• Experience developing products through a Phase Gate process as a Core Team member is highly preferred.
• Experience and or working knowledge of developing capital equipment is desired.
• Self-motivated, engaged, and productive.
• Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable.
• Must be able to drive for results.
• Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence.
• Able to predict and manage the expectations of project stakeholders
• Inspires and motivates others and provides work direction.
• A positive “Can Do” attitude.