Job Title: Manager, Research and Development
The Manager, Research and Development will lead Research and Development teams in the execution of product development projects aligning with the Divisional program strategy.
Key Responsibilities:
* Manage, schedule, costs/budget, and resources for assigned project(s).
* Interact with physicians for deep clinical understanding and research new unmet needs in a clinical area.
* Technical responsibility for all Research and Development activities assigned.
* Improve team processes and systems for quality and delivery of work.
* Identify new vendors and strategic partners for product development and component/subassembly supply.
* Maintain and improve high standard of medical device engineering.
* Work with other Research and Development Managers, Global Program Managers, and Global Directors to ensure sharing of Research and Development best practice.
* Manage the development of the IP portfolio for their area of responsibility.
* Team Management: mentoring, coaching, and development of direct reports to attain best performance.
* Perform routine appraisals to deliver best results and obtain maximum team performance.
* Manage the activities of the Research and Development Engineering team and hold regular team meetings.
* Foster and maintain a workplace culture respectful and supportive of individual differences.
* Ensure KPI's and business metrics are achieved.
* Ensure the Research and Development Engineering team are in compliance with Cook's Quality System requirements and Company HR policies.
* Ensure team/teams deliver quality designs in a timely manner.
* Foster relationships and collaborate with other functional stakeholders required for the successful completion of development projects.
* Must ensure effective communication of project progress and risks to all relevant stakeholders.
* Must work and interact effectively and professionally with and for others throughout various levels of the global organisation.
* Must strictly adhere to safety requirements.
* Must maintain company quality and quantity standards.
* Ability to remain calm and receptive in fast-paced situations.
* Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
Qualifications:
* Bachelor's degree in engineering (preferably in Polymer Science, Industrial Chemistry or Pharmaceuticals) or related field required and 10 years' relevant experience.
* Strong proven people management skills - a minimum of 5 years previous experience in a supervisory position leading and motivating a group of talented engineering staff desired.
* Proven project management skills.
* Strong technical writer.
* Good mechanical design, materials aptitude, and understanding of engineering fundamentals with extensive medical device materials knowledge.
* Strong medical device experience with combination product.
* Extensive proven knowledge of requirements associated with technical transfers to Manufacturing Operations.
* Must have good understanding of IP process.
* Good working knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820), EU Medical Device Regulation 2017/745.
* Willingness and availability to travel on company business.
About Cook Limerick:
Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support, and collaborative product development in the Innovation Centre.
The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook's products for global markets.
Research and Development in Limerick:
Our mission with R&D is to invent, manufacture, and deliver a unique portfolio of medical devices to the healthcare systems of the world.
Our R&D team in Limerick is split into two divisions, Vascular and Medsurg. The R&D engineering teams are responsible for bringing a product from idea or concept all the way to market launch.
The R&D Vascular division in Limerick has two programs, peripheral arterial disease (PAD) and venous therapies. The R&D engineers have the opportunity to create novel ideas within feasibility, learn and meet the requirements to bring a medical device through verification and validation, generation of a design history file and be a part of bringing a new product onto the market.
All this is done through collaboration within small or large R&D teams and working with cross-functional teams both locally in Limerick and globally with our sister companies.