Director, Research and Development

Position Overview:  

The Director, Research & Development is a senior leader within the Infusion Care Research and Development team, accountable for a wide portfolio of projects aimed at supporting delivery for the infusion care customer projects as well as larger product remediation projects. The role ensures strong technical leadership and sets technical strategic direction on design improvements, maintaining quality, driving cost and efficiency optimizations, and improving resilience of the products.  

This individual is charged with managing an effective team responsible for product design and verification/validation in compliance with medical device design controls. The individual will also be charged with managing R&D support for customers allocated. The individual may act as line manager for an R&D team, and drives a talent strategy, defines performance expectations and ways of working, allocates resources, and guides the team to deliver on a sizeable project portfolio. 

Key Responsibilities:  

• Lead a team to deliver on a portfolio of projects aimed at Infusion Care customers and according to infusion care product remediation strategy, including: 

• development of new product variants for customers, 

• raw material changes and qualifications driven by discontinuation, cost reduction, or supply chain resilience strategy,  

• maintenance or remediation of technical documentation for regulatory compliance, 

• Corrective and Preventive Actions (CAPAs) relating to product design, 

• product or packaging design changes to improve usability, maintain quality or reduce cost, 

• extending product ranges to fill critical portfolio gaps, 

• and supporting design transfer of new products into plant operations (NPI). 

• Lead a R&D team to provide in-market support of existing products by supporting design complaint investigations and customer inquiries regarding product composition. 

• Evaluate new projects’ resource requirements; estimate realistic times to completion. 

• Represent T&I for Infusion Care in the change control (CCR) and CAPA processes. 

• Develop clear and concise reporting of the team’s activities, priorities, and project statuses, and develop a cadence of regular communication to stakeholders. 

• Ensure project activities are carried out within a Design Controls Framework in accordance with ISO 13485 & 21CFR820 Quality Systems. 

• Actively partner, influence, advocate and engage the wider business functions such as Regulatory Affairs, Clinical, Marketing, Quality and Operations etc. at both peer and senior level to enable the effective delivery of projects. 

• Undertake regular reviews of budget and resource mapping R&D management to ensure that future resource needs and skills gaps are identified, training and budget forecast update and monitored, and where appropriate recruitment/ development initiated in a timely manner to fulfil the strategic intent of the Ostomy business. 

• Maintain compliance with company Health and Safety policies and ensure that direct reports are compliant. 

• Ensure that Quality standards are maintained via compliance with systems and SOPs, particularly in relation to Design Control. 

Skills & Experience:  

• Significant medical device industry experience, including at least 5 years of technical management/leadership responsibilities. 

• Proven experience leading and developing high performing R&D teams. 

• In-depth, demonstrable knowledge of medical device design controls in accordance with applicable regulations. 

• Broad understanding and appreciation of all key project functions such as technical (regulatory, quality, manufacturing, clinical) and commercial. 

• Strong track record of product development leadership delivering new products from concept to market by leading cross functional teams. 

• Excellent communicator and strategic thinker combined with a bias for flawless execution. 

• Ability to lead in a matrix structure, influence and build strong relationships. 

• Demonstrate leadership style that will build, develop and coach the cross functional teams. 

• Experience with the business-to-business interaction and projects (preferred). 

Qualifications/Education: 

• Degree in a Scientific or Engineering discipline (advanced degree preferred). 

• Working understanding of the ISO 13485 and 14971 standards, and FDA regulations for design controls.