Excellent opportunity for an R&D Manager to join a new company at the start up phases who is a strong leader with detailed and hands-on experience and knowledge of medical devices development for interventional cardiology.
The successful candidate will have an entrepreneurial spirit, the required persistence to succeed in a start-up environment, and the ability to work in a self-directed manner with minimal direction and supervision. The R&D Manager will be a team player as well as a team leader and have excellent communication skills. The R&D Manager will be based in the company’s Galway R&D facility, leading system development activities on-site and working in close collaboration with their European teams responsible for device characterization, other development functions, as well as quality affairs, and marketing functions. He/She will share the responsibility of realizing the clients full potential. Occasional travel will be required.
- Providing leading technical leadership to the R&D team to realize the Clients technology’s full potential. Develop and promote a culture of technical innovation, engineering from first principles, and a philosophy of being a knowledge leader in the field of business.
- Define project milestones, identify and manage the resources required to execute the project plan and the associated budget.
- Project Management; creates, drives, communicates & executes project plans, tasks and deliverables. Has excellent time management skills and a proven history of meeting project deadlines. Gives due consideration to team capabilities, organizational capabilities, design and program risks, and implement de-risking project management strategies to deliver projects to plan.
- Develops processes, materials, and solutions through in-house and external development paths.
- Evaluates external technologies and suppliers and strategically identify opportunities to implement these effectively within the Clients development programs.
- Ensure design meets company’s expectations in terms of quality, cost, and time.
- Oversees key projects, processes and performance reports, data, and analysis
- Uses structured problem-solving techniques and statistical methods for data-driven analysis and decisions
- Reviews and assesses designs and processes for potential patent opportunities. Support the VP of R&D in creating and managing intellectual property
- Support the VP of R&D in negotiating contracts with consulting firms/third parties to perform research or other applicable studies/support.
- Builds Quality into all aspects of work by maintaining compliance with all quality requirements
- Assist, as required, with the clinical trial or other clinical or pre-clinical programs and initiatives of the business.
- Demonstrate a primary commitment to patient safety and product quality.
- Understands and complies with all the regulations governing the quality systems
- Ensure that all members of R&D project teams have clear visibility, and are kept informed, of the information required for them to function efficiently in their roles.
- Appraise the Senior Management Team of progress, risks, status versus milestones
- In concert with the VP of R&D, senior management team, and peers, promote a quality culture across the team, grounded in compliance with policies, procedures, and regulations.
- Complete annual performance reviews for direct reports. Provide constructive feedback between reviews and support team members in their growth and development.
- Provides ongoing mentoring and technical guidance to other engineers & technicians
Skills, Qualifications & Experience
- A Bachelor’s or Master’s Degree in a relevant Engineering/Technical field with typically 10+ years of experience in a medical device environment or equivalent.
- Experience in leading R&D development teams within the Medical Device industry.
- Experience in cross-site product development
- Experience in designing, developing, manufacturing, and testing catheter-based medical devices (experience in large caliber delivery systems is a distinct advantage).
- Strong knowledge of materials and process capabilities for catheter-based medical devices
- Strong working knowledge and ability to use statistical techniques, six sigma, and Minitab analysis to support manufacturing processes.
- Experienced in ISO 13485, ISO 14971, compliant manufacturing & Risk Management tools i.e. DFMEA PFMECA, etc
- Ability to guide and fully motivate a team to achieve and demonstrate best practices in line with company objectives.
- Excellent verbal communication skills to enhance collaboration and writing skills to prepare/execute/communicate plans and reports
- Strategic Planner with successful scheduling & execution results