Senior R&D Manager
The Role
This position is responsible for leading people and departmental activities within the Research & Development and Product Development functions. The role covers all activities required to achieve clinical and commercial approval of new medical devices and may involve leadership of product development projects.
Reporting Lines
Reports to the Head of R&D (or designate).
Key Responsibilities and Duties
People Leadership
* Recruit, manage, and develop Senior and R&D Engineers, providing clear goals, feedback, and development opportunities.
* Build and maintain strong technical and clinical expertise within the team.
* Support departmental and program objectives aligned with the broader strategic plan.
* Manage health and safety within laboratory and testing environments.
* Develop and maintain departmental budgets and resource plans.
* Promote a culture consistent with organizational values in all interactions with colleagues and stakeholders.
Technical
* Ensure robust engineering practices are implemented throughout design and development to deliver reliable, high-quality medical devices.
* Oversee testing and verification activities, ensuring compliance with regulatory standards.
* Prepare documentation for submission to regulatory bodies (e.g., FDA and others).
* Contribute to clinical activities, including limited case support.
* Lead root cause investigations into identified product failures.
* Support the growth of the intellectual property (IP) portfolio through disclosures and innovation.
* Stay current with technological advances in relevant domains (e.g., polymer materials, nitinol, tissue engineering, test methods, imaging technologies).
* Monitor evolving regulatory standards and ensure alignment with development activities.
Project Management
* Manage new product development initiatives to meet patient, customer, and business needs.
* Serve as Project Lead when required, developing project plans, budgets, timelines, and resource requirements.
* Communicate project status, risks, and deliverables to stakeholders.
* Collaborate across multiple functions beyond R&D to ensure alignment and execution.
* Manage external vendors and partners to support development activities.
Essential Requirements
Technical
* Strong technical background with deep understanding of engineering principles, materials, and processes used in medical device development.
* Proven ability to ensure compliance with FDA, ISO 13485, and other regulatory requirements.
* Experience preparing regulatory submission documentation.
* Familiarity with design, verification, and process validation processes.
People Skills
* Demonstrated leadership ability with strong emotional intelligence and relationship-building skills.
* Experienced in mentoring and developing engineers, setting clear expectations, and fostering professional growth.
* Skilled at building trust across departments and external partners.
Problem Solving
* Encourages a collaborative, data-driven approach to problem solving.
* Ensures timely resolution of technical challenges with risk-based prioritization.
* Promotes best practices in data capture, analysis, and communication to drive decision-making.
Project Management
* Strong planning, organization, and communication skills.
* Experienced in managing projects from concept to regulatory submission and commercial readiness.
* Comfortable balancing technical leadership with people management responsibilities.
Initiative and Communication
* Proactive in identifying skill gaps, aligning activities with strategy, and driving team performance.
* Effective communicator with internal and external stakeholders.
* Able to create a positive, high-performance team culture.
Intellectual Property
* Supports team innovation by contributing to patent disclosures and IP portfolio development.
Education and Experience
* Bachelor's degree in Mechanical or Biomedical Engineering (or related field required).
* Minimum of 7 years' experience in medical device product development, including at least 3 years in project management or technical leadership.
* Experience in Class III cardiovascular devices preferred.
* Strong leadership and mentoring capabilities in building and managing small teams.
* In-depth knowledge of FDA and ISO 13485 requirements, with proven ability to apply them in product development.
* Experience working with subcontract manufacturers, suppliers, and test facilities.
* Previous experience preparing regulatory submissions to relevant agencies or authorities.
* Excellent organizational, communication, and time management skills.
* Strong problem-solving mindset with ability to thrive in dynamic, low-structure environments.