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Olympus Corporation of the Americas Director, R&D SUS in Westborough, Massachusetts

Working Location: MASSACHUSETTS, WESTBOROUGH

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.

Let’s inspire healthier lives, together.

Job Description

The Director of R&D will be a member of Olympus Surgical Technology of America’s (OSTA) R&D Leadership Team and will lead the single use endoscope (SUS) development team. The director will partner with the SUS Development Unit and 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 for execution of the design and development plan. The ideal candidate 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. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive collaboration with internal and external partners.

Job Duties

  • Demonstrated track record of partnering with Marketing to build a pipeline of new product development opportunities and presenting to Senior Leadership for endorsement/funding.

  • Experienced in building/maintaining a strong working relationships with Healthcare Practitioners (HCP’s) and representing R&D with internal and external partners.

  • Lead and mentor other R&D leaders and cross functional peers to ensure product development excellence and design robustness.

  • Develop a deep understand of the therapeutic/procedural spaces 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 product design and development, product registration and commercialization.

  • Oversee the creation of design control elements to comply with global medical device regulations.

  • 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.

Job Requirements

REQUIRED QUALIFICATIONS:

  • More than 15 years’ experience in the field of medical device development and commercialization is required.

  • A Bachelor’s of Science Degree in Engineering required, a Master’s of Science Degree preferred.

  • Minimum of 10 years leading teams and projects.

  • Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) and ISO14791 requirements.

  • Solid knowledge of global industry standards. (ex: ISO, AAMI, ANSI, etc..)

  • Hands on leadership skills with a track record with a proven track record of hiring, mentoring and leading a diverse technical team.

  • Strong collaborator with a history of delivering new products to market that meet user and business requirements.

PREFERRED QUALIFICATIONS:

  • 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 preferred.

  • 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.

  • Ability to travel domestically and internally based on project and business needs.

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.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,500 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

Olympus…True to You. True to Society. True to LIFE.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||

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