Director, Sustaining Research & Development

Rhian_Convatec; Wales; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

A global medical solutions company is seeking a Director, Sustaining Research and Development to lead the Ostomy Care portfolio. This role requires a strategic thinker with extensive experience in medical device design controls and the ability to drive product development in compliance with quality standards. Candidates should have a strong project management background and proven leadership skills in cross-functional teams. This position is hybrid, requiring travel up to 20% of the time.

Qualifications

• Demonstrable knowledge of medical device design controls.
• Experience in cross-functional team leadership.
• Ability to manage product development projects.

Responsibilities

• Lead a team to sustain and innovate the Ostomy Care product line.
• Manage compliance with quality and regulatory standards.
• Develop and report on project activities and statuses.

Skills

Medical device design controls

Project management

Effective communication

Leadership in cross-functional teams

Ostomy market knowledge

Education

Degree in a Scientific or Engineering discipline

10+ years of medical device industry experience

Tools

ISO 13485

FDA regulations

Job description

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit convatecgroup.com

Every day, our products improve the lives of millions of people around the world. We’re hugely proud of this, which is why we’re transforming our business to reach millions more. Join us as a Director, Sustaining Research and Development and you’ll drive progress that really means something.

Director, Sustaining Research and Development

Position Overview:

The Director, Sustaining Research & Development is a senior leader within the Ostomy Care Research and Development team, accountable for a wide portfolio of projects aimed at sustaining the vitality of the Ostomy Care portfolio through product line extensions and design improvements, maintaining quality, driving cost and efficiency optimizations, and improving resilience. The scope encompasses all Convatec Ostomy Care’s on-market pouching systems and accessories, as well as the Flexi-Seal fecal management system.

This individual is charged with building and managing an effective team responsible for product design and verification/validation in compliance with medical device design controls. As the line manager for the Ostomy Care Lifecycle Management team, the Director, Sustaining R&D develops 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 sustaining the on-market Ostomy Care product range, including: - 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; - new or improved test method development; - extending product ranges to fill critical portfolio gaps; and supporting design transfer of new products into plant operations (NPI).
• Lead a 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.
• Prioritize resource deployment in alignment with stakeholders’ priorities and overall business impacts.
• Represent Technology & Innovation for Ostomy Care in the change control (CCR) and CAPA processes.
• Develop, communicate, and hold the team accountable to high standards of timeliness and quality of work.
• Develop annual budgets and talent strategies and manage within them.
• Develop clear and concise reporting of the team’s activities, priorities, and project statuses, and develop a cadence of regular communication to stakeholders.
• Ensure all required feasibility work, analysis, validation, testing and trials are performed on time and to the required Quality and Regulatory standards, as well as in line with Convatec procedures and processes.
• Maintain a working technical knowledge of a broad range of manufacturing processes and materials areas relevant to the Ostomy Care product range.
• 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.
• 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.
• To ensure compliance with the legislative and internal requirements of the EHS and to participate in the fulfilment of the company\'s targets in the EHS area.

Skills & Experience:

• 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.
• Experience with the ostomy market is preferred.
• 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 in line with Convatec High Performing Team principles.

Qualifications/Education:

• Minimum of 10 years of medical device industry experience, including at least 5 years of technical management/leadership responsibilities.
• 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.

This is a hybrid role linked to our office in Deeside, UK, Haina, Dominican Republic or Michalovce, Slovakia. This position will require travel up top 20% of the time.

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Ready to join us?

AtConvatec, we’repioneering trusted medical solutions to improve the lives we touch. If you’rereadyto make a real impact, apply today and help us bringour Forever Caring promise to life.

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