Sequana Medical NV is looking for a Manager of Engineering & Development (Zürich – 100%)
General Description
Leads the Engineering & Development department of Sequana Medical to ensure timely delivery of hardware and software components including their technical documentation for new products and system components, product improvements and production test systems based on user and process requirements. Ensures full compliance of engineering activities and technical documentation with the company’s quality management system. Supports the manufacturing team in ensuring product availability for the planned lifetime. Supports the manufacturing, sales and clinical team in all technical aspects.
Key Responsibilities
- Team leadership based on a culture which ensures supportive, productive working relationships with fact-based decision making
- Management of the engineering team and external partners to meet defined timelines and company goals
- Overall responsibility for hardware, firmware and software development for new products and system components, product improvements and production test systems
- Requirements engineering and technical design specification
- Product verification strategies and implementation (specification, planning, testing, documenting)
- Creation and maintenance of technical documentation
- Supports Component life cycle management
- Implementation and maintenance of processes for engineering activities in collaboration with QM/QA/RA department
- Internal technical support and training
- Send out Technical Reports (e.g. DirectLink) in collaboration with RA to customers
- Root cause analysis of nonconforming products, systems and components
Key requirements
- Demonstrated ability to develop a "hands-on" approach, requiring personal initiative and responsibility while operating at a high level of performance and efficiency
- Proactive and hands-on ability to lead the engineering activities required to meet Sequana Medical’s engineering objectives
- Demonstrated ability to operate in a venture capital backed company environment with the entrepreneurial drive to proactively participate to the engineering activities required to meet Sequana Medical commercial objectives
- Demonstrated ability to manage engineering in a medical device industry or in other highly regulated environments
- English and German in reading and writing
- Demonstrated ability to lead and motivate a team
Required Education / Experience
- Master’s degree in medical device engineering, mechatronics engineering or similar
- Experience in the medical device industry including hard- and firmware / software development
- Development experience in the field of embedded systems or software preferable
- More than 3 years team leadership experience