Director R&D

About the role

The Director of R&D at Imperative Care is responsible for interpreting functional strategy and setting plans that meet research and product development goals and objectives. This role oversees all activities of assigned R&D teams, projects, and cross-functional project teams.

Responsibilities

• Direct and oversee all activities of assigned R&D teams, projects, and cross-functional project teams and ensure tasks performed by reporting people leaders or individual contributors stay within prescribed time frames and funding parameters when transferring projects to manufacturing or contract manufacturer.
• Lead assigned R&D team and provide clear direction that supports functional goals and objectives.
• Provide development opportunities and manage performance of R&D team while fostering an environment of collaboration, growth, learning and achievement.
• Collaborate with internal cross-functional teams, including Senior Management and external stakeholders including KOLs, advisory boards, contract manufacturers, suppliers and development partners to understand current and future product development requirements, review project goals, priorities and resources and guide decisions that optimize projects.
• Lead clinical needs-based brainstorming activities leading to new design solutions.
• Direct R&D teams to rapidly prototype new ideas within and outside the stroke space, as required.
• Develop project budgets, program timelines, organize resources according to project requirements and maximize expenditures within limitations of department and project budget allocations.
• Identify and assign resources to specific phases or aspects of project (e.g., product design and process development, pre-clinical studies, design and process characterization and qualification, finalization of specifications, strategic project/technical plans, etc.).
• Represent R&D in high level cross-functional discussions with potentially impact on clinical, regulatory, and business needs.
• Monitor product complaints to understand issues with the devices. Utilize deep knowledge to lead design improvements to the current device or for implementation to future designs.
• Ensure product design follows engineering principles, company standards, clinical requirements, and related specifications.
• Supervise technical development activities and scheduling, resolve engineering design/test problems.
• Oversee integration of technical activities and related support activities (i.e., marketing, regulatory, quality, clinical, manufacturing).
• Prepare and lead R&D engineering team through design control documentation and processes.
• Attend professional meetings (e.g., Professional conferences, Symposia) to build network of contacts, advance technological knowledge and to ensure professional expertise is maintained.

Requirements

• Bachelor's degree in engineering or related field, and a minimum of 10 years of experience including 3+ years of managerial experience; or equivalent combination of education and work experience.
• Product specific experience in medical device/pharmaceutical field and advanced degree are preferred.
• Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings preferred.
• Knowledge and interpretation of applicable regulations, guidelines, and policy statements (QSR, MDD, and ISO) preferred.
• Excellent written and verbal communication skills; technical writing capabilities are a must.
• Ability to influence decision-making/action across organizations, independent of reporting structure.
• Proven ability to manage a team of professionals and prioritize multiple projects independently.
• Ability to work as an effective leader, be flexible, adaptable, and to work under pressure.
• Demonstrated business acumen and ability to understand technical aspects of product development.
• Able to travel up to 25% of the time.

Qualifications

• Must have a Bachelor's degree in engineering or related field.
• Minimum of 10 years of experience, including 3+ years of managerial experience.
• Advanced degree preferred.
• Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings preferred.
• Knowledge and interpretation of applicable regulations, guidelines, and policy statements (QSR, MDD, and ISO) preferred.
• Excellent written and verbal communication skills; technical writing capabilities are a must.
• Ability to influence decision-making/action across organizations, independent of reporting structure.
• Proven ability to manage a team of professionals and prioritize multiple projects independently.
• Ability to work as an effective leader, be flexible, adaptable, and to work under pressure.
• Demonstrated business acumen and ability to understand technical aspects of product development.
• Able to travel up to 25% of the time.

Skills

• Strong leadership and management skills.
• Excellent communication and interpersonal skills.
• Technical writing and presentation skills.
• Experience with medical device and pharmaceutical industry regulations.
• Ability to work effectively in a cross-functional team environment.
• Ability to manage multiple projects simultaneously.
• Strong problem-solving and analytical skills.

Benefits

• Stock options
• Competitive salaries
• 401k plan
• Health benefits
• Generous PTO
• Parental leave program

Pay

$235,000 - $255,000 annually

Schedule

Full-time, on-site position