Executive Director, R&D - Single Use Endoscopy (Respiratory & ENT)
Working Location: MASSACHUSETTS, WESTBOROUGH
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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.
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’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.
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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 ||
Nearest Major Market: Worcester
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