Director of Research Development

My Client is a mission-driven, venture funded medical device company dedicated to developing and deploying next-generation vascular thrombectomy solutions. Our innovative solutions aim to improve patient outcomes in pulmonary embolism and other vascular conditions. The company is in Menlo Park, CA. (Must be local to this office)

The Director R&D Engineering is responsible for leading, managing, and developing all R&D resources that execute multiple new product development programs.

PRINCIPAL DUTIES AND RESPONSIBILITIES

1. Leads direct reports (R&D Engineers and Technicians) and leads Sr. R&D Managers to design, develop, and navigate programs from concept to launch.
2. Interacts with a cross site, cross functional teams as well as external groups (e.g. KOLs) to develop strategic plans encompassing all necessary business elements of the product development plan from concept to program launch globally.
3. Supports R&D function and participates in discussions to influence PRC (Product Review Committee comprised of BU GM and functional VPs) regarding the program functional plans and the program goals and progress against those goals.
4. Develops strong relationships and program leadership with cross-divisional and cross-functional team members to accomplish agreed upon deliverables, timelines and methodology. Uses facilitative leadership to solicit input from all cross functional members to arrive at the best decisions to reach portfolio milestones.
5. Establishes and communicates critical objectives, monitors progress, assesses risk, and implements strategies to ensure successful delivery of the program
6. Resolves conflicts and issues goals with team members, product teams, functions, businesses, etc. to ensure successful achievement of overall goals and timelines. Cross functional team leaders must balance each functions (marketing, clinical, reimbursement, R&D, marketing, operations, quality and finance) agenda/priority within the context of program goals and milestones. Only difficult, unresolved conflicts are escalated to higher levels of the organization.
7. Provides coaching and feedback to team members and their functional managers to keep program moving forward.
8. Facilitates the cross functional team discussions to leverage the expertise of cross functional team members to arrive at aligned decisions and program direction. Coaches and at times directs the functional managers as they lead their teams.
9. Evaluates resource and/or functional gaps and addresses these gaps through resource utilization and or development of team members to fulfill requirements of the program.
10. Provides feedback to managers on team member performance and contributions working on the program across sites, businesses, and functions.
11. Leads and collaborates with cross functional groups to set program budgets and helps manage the overall budget of the of the collective programs annually.
12. Collaborates with the quality and operations group for manufacturing and the clinical group on trial execution as required to ensure seamless execution and development of best practices

1. Leads the conceptualization of new methodologies, materials, systems design, user-centered designs, and processes for new products development early in product design phases with other functional groups. Leverages existing product development projects, product performance, and feedback from product commercialization to improve design of medical devices, design transfer and commercial support for customers and patients.
2. Directs staff to employ existing, improved, and new methods during initial design to market release for improving the manufacturability, reliability, safety, user-centered and patient centered performance of products.
3. Monitors documentation throughout all phases of research and development to ensure it meets internal and external requirements.
4. Develop and implement consistent common processes, plans, work practices, and strategies within the team.
5. Accountable to improving processes, procedures, and simplifying the complexity of systems.
6. Selects, develops and evaluates personnel to ensure the effective and efficient performance of new product development projects.
7. Optimize employee performance by mentoring and developing diverse employee talent necessary to meet evolving business needs.
8. Communicate requirements, expectations and goals clearly to employees. Ensure understanding of all quality policy/system items that are specifically applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
9. Maintain morale and support to improve employee engagement, inclusion, and innovation initiatives.
10. Ability to interpret and stay current with FDA, EU and other national regulations and guidelines.

EXPERIENCE requirements

1. Minimum of 10 years of relevant experience with 7 years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7 years of managerial experience
2. 5 years of leadership experience in R&D and product development
3. 10 or more years in medical device product development/quality/operations, or other highly regulated environment.

Education Requirements

1. Bachelor’s in engineering, scientific, or appropriate technical discipline.

Other qualifications

1. Proven technical and leadership skills including:
2. Influence management
3. Technical problem solving
4. Excellent downward, lateral, and upward communication skills
5. Highly developed skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes.
6. Good balance of high level strategic and detailed technical thought processes.
7. Combination device experience