Senior Manager R&D - Technical Project Lead

Pioneering trusted medical solutions to improve the lives we touch: Unomedical s.r.o. is a member of Convatec, 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.

The Senior Manager R&D - Technical Project Lead will be part of the R&D Infusion Care business unit. The role is to have a key focus on leading technical development of allocated customer projects, remediation projects, or change projects. This 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:

• Overseeing technical progress and making technical decisions for allocated projects and acts as lead engineer.
• Leading technical 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 are progressed on time and fulfilling the agreed quality target.
• Ensuring escalation of project issues to the NPDL and/or set governance.
• Working 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 ensuring sufficient competencies within the team that can support the NPDL’s goals and targets.
• Including specific reference to cross-functional work and project-based requirements if appropriate.
• Ensuring abbreviations/acronyms are either not used or clearly explained.

Skills & Experience:

• Proven track record of managing a technical team in a regulated industry.
• 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 of 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) is required.
• Experience working within the Medical Device Industry or equivalent regulated industry in a Lead Engineering role with a proven track record of delivery excellence.
• Experience managing technical teams.
• Ability to understand business and operational objectives, and to prioritise high volume and complex workloads accordingly.
• Excellent technical and non-technical communication skills in English, both written and verbally.

Team:

The role has the potential to manage a team between 1-7 direct reports over time.

Travel Requirements:

Up to 10 travel days annually internationally. Weekly commute between the two DK sites.

Languages:

English (speaking, reading, and writing). Additional languages are welcomed.

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge. This is work that’ll move you.