Senior Manager, Medical Device Quality Engineer - Belgium
- We put our heart, soul and skills into making a difference for people living with severe disease.
- Working together to push the boundaries, we blend the best of our talents to unlock innovation.
- Will you join us in our pioneering adventure?
- To strengthen our Medical Devices Team, we are looking to fill the position of Senior Manager, Medical Device Quality Engineer
- This role is focused on ensuring the technical quality and life cycle management of drug delivery technologies and other medical devices for our company’s chemical and biological medicines pipeline.
- This work will be performed in the context of cross-functional technical program teams that ensure the design, development, industrialization, and life cycle management of medical device programs to meet the needs of internal stakeholders and ultimately patients.
- Within the context of these teams, the role can alternately be a contributor focused on medical device industrialization topics or the program leader ensuring all aspects of the program. Importantly, although the role is focused on ensuring technical quality for marketed products, it is not restricted solely to these considerations.
- Anticipating and challenging the full scope of program activities (and receiving challenges from other team members) is expected and encouraged.
- This role is expected to work closely with cross-functional product teams within the company and to provide an interface between internal and external partners.
- Coordination of the technical activities supporting on-market and life cycle management of medical devices related to their design, development, and industrialization in the frame of cross-functional technical program teams
- Project management of technical medical device activities in relation to market feedback, life-cycle management and maintenance of technical quality and documentation with both internal and external partners
- Assessment and control of budgets and timelines relating assessment, maintenance and improvement opportunities within program teams and with external partners
- Project planning and tracking as well as anticipation of total program challenges within program teams
- Preparation, justification, and strategic planning of life cycle management opportunities including for secondary regulatory submissions and post-market approval obligations
- Preparation and proposal of new strategic programs, including translation of internal customer requirements into realistic product and program requirements.
- Evaluation of new devices and technologies to supplement and improve existing platforms or to propose new programs
- Ensuring compliance with combination product and medical device quality management systems with a critical interface to quality assurance and medical device vendor management teams
- Ensuring protection of all intellectual property that may arise from programs
- Proven track record in project management, medical device development, industrialization, production, quality
- Pharmaceutical business experience and familiarity with competitive landscape of devices and pharmaceuticals, drug development process, health economics and health outcomes
- Knowledge of Good Manufacturing Practice and evolving regulatory and quality expectations in the field of medical devices and mobile health, including human factors engineering
- Project management skills in planning, tracking, controlling, anticipating, challenging projects
- Proven track record in managing and leading internal and external project teams
- Leadership of internal and external project teams
- Experience in evaluating external projects and technologies
- Experience in integrating medical device activities with the needs of regulatory submissions
- Exposure to budget and financial management
- Exposure to intellectual property management including design and patent procedures and processes
- Exposure to managing and negotiating contracts and agreements
- HS&E processes and procedures
- Leading and influencing cross-functional and matrix teams
- Motivation, empowerment of teams and leading by example
- Management of external relationships
- Program advocacy, negotiation (internal and external) and conflict resolution
- Written and oral presentation skills
- PhD or Master's degree preferred
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