Department: Research and Development
Reporting: R&D Director
The Operations Manager is accountable for the leadership, planning, oversight and execution of manufacturing and supply chain operations. The individual must have the ability to work independently and as an effective and engaged team member in a dynamic, fast-paced environment. As a member of a growing team the Operations Manager must be flexible and willing to carry out tasks outside of their routine responsibilities.
DUTIES & RESPONSIBILITIES
The role of the Operations Manager includes but is not limited to the following responsibilities and skill sets:
- Lead the company’s operations and define manufacturing strategy to ensure products are built and delivered to the market on time and in line with forecasts & orders.
- Definition and maintenance of outsource manufacturing partnerships.
- Responsibility for capacity planning to ensure product supply.
- Working closely with R&D to optimise manufacturability at an early stage in the design and development process.
- Managing premarket product qualification activities, product launches and ramp-up to high volume supply.
- Working with Sales and Marketing function to ensure that there is a strong relationship between Operations and the Sales Organisation.
- Ensure that all manufacturing activities follow quality and regulatory requirements.
- Work with internal team members to explore new technologies, assess in terms of performance, cost and reliability.
- Degree level 8 in Engineering or related discipline with 8 years + relevant experience, including 3 years managerial experience – additional relevant qualifications may be advantageous.
- Experienced with medical device process and manufacturing development and project/program management, risk analysis and problem-solving skills.
- Track record in people management, organisation development and relationship building.
- Dynamic team player and can work effectively and proactively on cross-functional teams and with key external partners.
- Excellent understanding of ISO 13485 and FDA design and development processes.
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
- Excellent communication and presentation skills.
- Thinks critically and makes sound decisions.
- Collaborates and creates alignment as a team member/leader.