Director R&D Product Development

About the position

As an integral member of the R&D team, the Director, R&D Product Development assists in leading the implementation of the product development vision by providing technical leadership and management to support the Company’s innovation goals in the Interventional Urology space. This position directs and coordinates activities in Research and Development in accordance with company policies, goals, and objectives.

Responsibilities

• Actively participate in improving the R&D function by pursuing opportunities to develop the team’s strategies, organization, personnel, and execution of business initiatives.
• Collaborate with cross-functional leaders across the organization to support the Company’s goals.
• Provide leadership in growing the R&D teams through recruiting top engineering talent, managing and mentoring engineers to provide continuous learning and growth.
• Outline career development plans for technical engineers and managers and provide coaching and feedback to ensure they can grow and succeed in their roles.
• Create a team environment that supports a strong collaborative drive to succeed with company initiatives.
• Support project management by assisting in product development planning and execution while resourcing projects adequately with engineering talent.
• Develop detailed budgets to support product development, departmental growth, and business objectives.
• Oversee and direct R&D efforts of the Company toward efficient completion of the Company goals and objectives.
• Direct and coordinate the planning, scheduling, and budgeting related to R&D activities.
• Provide technical contributions to product development projects.
• Interface with experts from outside sources, companies, and forums to maintain an understanding of new developments in medicine and engineering.
• Partner with Marketing and directly with customers to help ensure development and testing of prototypes meet market and customer requirements.
• Provide guidance and ongoing review in the development of final reports for regulatory submissions.
• Oversee the review of document changes for Research and Development impact.
• Ensure compliance with department team members regarding job descriptions and training requirements.
• Participate in the development of Company standards and procedures.
• Represent R&D team in Quality Audit Teams.
• Generate invention disclosures to support patent applications for new technology.
• Stay current with technology, practices, and general engineering knowledge related R&D through seminars, literature, and peer groups.
• Maintain sufficient and accurate technical records in an engineering notebook per company policies.
• Perform other duties as assigned.
• Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Requirements

• Bachelor’s degree in engineering with at least 15 years of experience, or a Master’s degree with at least 12 years of experience, or a Ph.D. with 8 years of experience (Preferably biomedical or Mechanical engineering).
• Minimum of 5 years of leadership experience; management of direct reports, required.
• Experience with class II and Class III medical devices is required.
• Successful track record of developing new product innovations, including implant and mechanical delivery devices for surgical applications.
• Experience with SolidWorks.
• Proficient in all phases of product development including design, implementation, verification, validation, and manufacturing.
• Exceptional verbal and written communication skills.
• Expertise with ISO 13485, MDD, and FDA QSR requirements.

Nice-to-haves

• Business Development, M&A experience is desirable.
• Knowledge of biomaterials, chemistry with experience with Non-Animal Stabilized Hyaluronic Acid (NASHA) a plus.

Benefits

• Medical, prescription drug, dental and vision insurance.
• Flexible spending accounts.
• Participation in 401(k) savings plan.
• Various paid time off benefits, such as PTO, short- and long-term disability and parental leave.