Senior Manager – External Research and Development Engineering

Pioneering trusted medical solutions to improve the lives we touch: Unomedical s.r.o. is a member of Convatec which 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 around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

We’re a business that never stands still. Join us on our journey to #ForeverCaring as a Senior Manager – External Research and Development Engineering, and you won’t either.

 

The Senior Manager will be part of the R&D infusion care business unit. The role is to have a key focus on leading and be responsible for all outsourcing activities of technical development of customer projects, remediation projects, or change projects. The role will have a secondary focus on leading internal development projects as well. The external relations and project leadership will be done in close collaboration with the NPDL. The role‘s objective is to deliver on a subset of the NPDL’s goals and targets. The manager is furthermore to have direct reports of technical resources.

Key Responsibilities:

• Maintaining, establishing and managing new and current external collaboration of partners, incl. contractual relationship, negotiation and project management.

• Overseeing technical progress and making technical decisions for allocated projects and acting as lead engineer.

• Managing pipeline requests for outsourcing activities and ensuring identification of appropriate external partners qualified for the R&D need.

• Documentation development and design control of projects.

• Leading design exploration and/or improvements.

• Keeping the overview of documentation and dependencies across R&D product portfolio according to the design control processes.

• Ensuring that projects are aligned with the NPDL and key stakeholders on critical decisions.

• Ensuring that all technical aspects of a project including documentation is progressed on time and fulfilling the agreed quality target.

• Ensuring escalation of project issues to the NPDL and/or set governance.

• Work together with cross functional product development engineers to optimize designs for manufacturability, build prototypes and conduct proof-of-principle, and pilot-scale manufacturing trials.

• Handling the day to day work of direct reports.

• Building a strong team collaboration and ensure sufficient competencies within the team that can support the NPDL’s goals and targets.

• Include specific reference to cross functional work and project-based requirements if appropriate.

• Ensure abbreviations/acronyms are either not used or clearly explained.

Skills & Experience:

• Proven track record of managing a technical team in a regulated industry.

• Proven track record of managing and successfully collaborating with external partners for R&D projects.

• Proven track record of directing R&D teams.

• Good understanding of ISO 13485 and design controls.

• Lead Engineering experience.

• Practical experience on design control and documentation development for class II+ products.

• Experience in applying in-depth process knowledge to help inform design and process FMEAs, set realistic tolerances, devise sampling plans, and the like.

• Track record of participating in product development projects needing Design for Manufacture and Design for Assembly considerations.

• Proven track record of applying modern engineering theory, critical thinking, and statistical analysis to structure problem solving and process design optimization.

• Good understanding for mechanical engineering disciplines such as tolerance analysis, molding, CAD drawings, requirement engineering, design verification and validation principles.

• Proven ability to navigate a broad stakeholder environment.

• Proven track record of being a technical decision maker.

Qualifications/Education:

• Bachelor’s Degree in Science or Engineering (or equivalent) required.

• Experience working within the Medical Device Indus