Executive Director, R&D - Single Use Endoscopy (Respiratory & ENT)

Job Description

The Executive Director of R&D –Single Use Endoscopy (Respiratory & ENT), will be a member of Olympus Medical’s Single Use Endoscopy and Enabling Technologies (SUE) R&D Leadership Team. The Exec. Director will partner with Global Respiratory and ENT Business Unit’s 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 SUE NPD Projects. The ideal candidate will be a hands-on technical leader, device subject matter expert (SME) and be responsible for defining and maintaining the technology and product roadmaps for SUE.

This role serves as the SUE R&D’ point of contact for the Respiratory/ENT Business Units (BU) Leaders and works closely with the BU leaders to ensure the SUE NPD pipeline is competitive and delivers on the NPD project milestones for on-time launch and QICD-B metrics.

Job Duties

* Partners with the designated BU commercial leaders to create a strong NPD development pipeline that meets and exceeds the overall Single Use Endoscopy (SUE) Respiratory / ENT BU business growth goals and objectives.

* Provides technical leadership to the SUE NPD teams to ensure design, verification and validation of each product and its components are appropriate for approval and manufacturing.

* Collaborate closely with all functional areas necessary to aggressively advance products from proof-of-concept through validation and product launch.

* Partnering with Marketing to build a pipeline of new product development opportunities and presenting to Sr. Leadership for endorsement/funding.

* Experienced in building/maintaining a strong working relationship 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.

* Lead all project technical execution activities in the pre-product development phase of new product development.

* 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:

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

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

* Minimum of 10 years leading teams and projects.

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

* Experience in developing Single Use visualization products a plus.

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

* Extensive knowledge of engineering principles, concepts and applications.

* Ability to travel domestically and internally based on project and business needs

PREFERRED QUALIFICATIONS:

* Hands on leadership skills 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.

* 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.

* 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.