Our client a medical device company who have recently established an Irish operation are currently seeking an R&D Manager to support development of delivery system for a new and innovative device to support the heart. Reporting to the VP of R&D the R&D Manager will be a leader with detailed and hands-on experience and knowledge of medical device development for interventional cardiology and will lead system development activities on-site
Role/Responsibilities
Providing leading technical leadership to the R&D team to realize 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 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.
Understandsand 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/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
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322