Surgical Sutures Program Manager, R&D, MedTech Surgery  

Do you want to be part of a team that is committed and passionate about knowledge and challenges? Do you want to work in a learning and cooperative environment? Do you want to contribute with your work to improve the lives of patients?   

Role Purpose 

An opportunity has arisen for a self-driven and committed R&D Manager to join a multinational medical device company to lead the Surgical Sutures Group in the R&D area. As Surgical Sutures Program Manager you will serve as a strategic member of the Wound Closure R&D Leadership Team and represent R&D in identifying growth opportunities in partnership with Global Strategic Marketing and Business Development. 

Reporting to the Head of R&D, your mission will be to be responsible for the development, optimization and implementation of current and new product portfolio for Surgical Sutures, as well as ensuring the launch, profitability, quality and compliance with international standards and regulations, fostering a culture of technical excellence. The role requires a strong collaborative and partnership approach across R&D, Global Strategic Marketing, Medical & Scientific Affairs, Engineering, Supply Chain, and Project Management Office. 

Obligations & Responsibilities 

• Leads the effective implementation of the Surgical Sutures’ I+D program/project portfolio (both short term and long term) to required standards, timelines and budget, plus managing resources to ensure fulfilment of portfolio requirements, ensuring appropriate and timely business outcomes, guaranteeing alignment with strategic objectives. 

Accountable for evaluating trade-off decisions to help the team handle the triple constraint (time, scope, resources) and for appropriate resolution of challenges. 

• Acts as responsible and key authority on product design, verification and validation processes for the Surgical Sutures program / portfolio, e.g.: 

• supporting translation of customer needs, strategic market and clinical inputs into technical specifications and performance requirements, 

• conducting technical design reviews and risks assessments revisions to ensure the safety and performance of medical devices in the surgical sutures field, 

• providing technical oversight to pre-clinical and clinical trials,  

• supporting technology transfer to production, collaborating with the Operational area to ensure industrial feasibility of new products, 

• supporting the development, creation and management of Technical Files, ensuring its compliance with international standards and regulations and QM system, in collaboration with the Regulatory Affairs team, 

• supporting and supervising submissions for approval of the competent international health authorities (TÜV, FDA, PMDA or NMPA), in collaboration with the Regulatory Affairs team, 

• providing technical advice in the field to internal stakeholders (Medical Scientific Affairs, Marketing, Regulatory Affairs, Operations or Finance), 

• participating in audits of competent regulatory authorities. 

• Owns Goals & Objectives (G&O) definition for Sutures R&D deliverables, ensuring alignment amongst cross functional partners for key initiatives, goals, and strategies through shared G&O’s and KPIs. 

• Coordinates and leads the program/portfolio management activities of a high performing team, regularly reviewing and adjusting plans, setting challenging goals and focusing on priorities.  

Provides the team with support, technical oversight, guidance and expertise, ensuring adherence to best practices and methodologies, guaranteeing that the goals and objectives are defined, understood and met, and the strategy is adequately addressed and supported. 

Coaches, mentors and guides the team by fostering a culture of knowledge and innovation, technical excellence, customer orientation and cooperation. 

• Monitors the external technology environment, identifying and assessing technology opportunities in the Surgical Sutures field, e.g. technology advancements, strategic partnerships, technological platforms, etc, and making recommendations on implementation feasibility. Technical leading or support of the resulting outsourcing, partnership or offshoring scientific and technological activities.  

• Develops knowledge of technical platforms in other innovation hubs of the Group and establishes relationships with key groups that have strategic alignment. 

• Identifies capability gaps and leads development of build/buy plans 

• Oversees and ensures strong cross-business collaboration with Medical Scientific Affairs, Marketing, Regulatory & Operational areas, including joint identification of growth opportunities. 

• Communicates progress, risks and resources needs to the Head of I+D.

Professional Competencies  

Degree in Life Science, Chemical, Materials, Industrial, Biomedical Engineering or other relevant technical discipline is required. Ph.D or additional postgraduate or master's training in R+D, Innovation, MBA or Materials Technology (polymers, textiles or related) will be valued. Specific technical expertise in material science and production processes of surgical sutures will be a plus.  

8 to 10 years of recognized experience and working understanding within one or more progressive responsibility roles in R&D and technical leadership, preferably of medical product development (Class III) and associated regulatory compliance requirements for EU market is essential.  

Demonstrable experience and competence in project management.  

Working knowledge of intellectual property, joint developments and strategic partnerships. 

Working with international and external stakeholders, a full professional proficiency in English is a must. 

High level of proficiency in MS Office software. 

Personal Competencies 

Detailed practical and deep understanding of the full process of medical device research, design and development. 

Skilled in risk assessment and mitigation in highly complex, regulated environments. 

Well-organized and with strong attention to detail with an ability to deal with competing priorities. High level of problem-solving capability and business acumen and quickly and objectively drive the team towards a path which maximizes value, while maintaining the end-to-end cross-functional view. 

Proven success in partnering and influencing across a matrix environment. 

Customer oriented and high performance to be part of a passionate team. 

Manages tasks effectively, adapts to change, strives for continuous improvement, and maintains focus under pressure for goals achievement.  

Demonstrated capacity to interact with the full stakeholder base, both internal (Medical Scientific Affairs, Marketing, Regulatory Affairs, Operations or Finance) and external (surgeons, regulators, innovation partners, OEM collaborators / customers). 

Excellent communication & collaboration skills with a wide range of internal and external stakeholders including management, customers, key opinion leaders and regulators. 

In-depth people and resource management experience, building trust, inspiring and motivating others, taking responsibility for team actions, listening and providing feedback and recognition. 

Ensures an environment of collaboration; open/safe challenges and risk discussions 

Fosters teamwork, diversity, and inclusion within team, between teams and other groups 

Keeps commitments, acts with honesty and fairness, takes responsibility for decisions, and aligns actions with company values. 

Positive attitude towards challenges. 

Demonstrated comfort with ambiguity. 

Up to 25% travel may be required 

 B. Braun Surgical, S.A.U. | Victoria Merodio