Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day. We're currently looking for the Director of Research and Development, Sustaining Engineering to join us in our Southborough, MA office.
Let's inspire healthier lives, together.
The Director R&D will be a member of Olympus Surgical Technology of America's (OSTA) R&D Leadership Team. The Director will partner with Global Marketing to identify unmet needs in targeted therapeutic/procedural space(s), jointly develop a compelling business case to support funding requests and lead the technical team responsible execution the design and development plan. He/ she will be a hands-on technical leader and device subject matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. The position's area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. The incumbent will have extensive collaboration with internal and external partners.
As a Director of R&D Sustaining Engineer working on the OSTA R&D Leadership team, you will be empowered and inspired to do your best work. You will contribute to our mission by leading and mentoring a talented technical team and contributing to the success of Olympus. In a typical day, you will:
Lead and mentor a highly functioning technical team.
Develop a deep understand of the therapeutic/procedural space across the business and build a network of internal and external partnerships required to meet business growth expectations.
Provide project and technical leadership on cross functional teams through clinical development, product registration and commercialization.
Lead the creation of design control elements to comply with global medical device regulations.
Establish and maintain detailed project plans, define risks and recommend contingency plans as required in collaboration with the program manager and cross functional team members.
Lead all project technical execution activities and oversee the development of statistically sound design verification protocols/reports and design validation.
Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers.
Collaboration across Olympus's Global R&D organization to identify technology development opportunities and advance research in support of the business direction.
Perform all other duties as assigned.
Bachelor's Degree in Engineering required,
Minimum 10 year's of experience in the field of medical device development and commercialization is required.
Minimum of 5 years leading teams and projects.
Ability to travel domestically and internally based on project and business needs.
Master's of Science Degree preferred.
Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) and ISO14791 requirements.
Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc.).
Strong hands on technical leadership skills with a track record of delivering new products to market.
Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences, is desirable Design for Six Sigma (DFSS) certification is highly desirable.
Prior experience leading projects with external design, development and manufacturing partners.
Working knowledge of solidworks a plus Extensive knowledge of engineering principles, concepts and applications.
An aptitude for project foresight and contingency planning Effective planning and organizational skills.
Excellent writing and oral communication skills Ability to mentor technical and cross functional team members.
Strong collaboration skills with internal and external partners.
We realize work isn't just a job to you.
It's a big part of your life, but not the only part. That's why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks so you can be ready for where life can take you.