Senior Hardware System Engineer

Lausanne, Vaud, Switzerland        ·       Full time

About the job

Every year, approximately 750,000 people worldwide suffer a spinal cord injury, resulting in a challenging quality of life for those injured and their loved ones. ONWARD is addressing this urgent need for more effective SCI therapies. We translate breakthrough science into technologies that transform the lives of people with SCI in every way that matters to them.

Are you passionate about health and technology? Do you want your work to have an impact and serve others? From clinicians to engineers to marketers, everyone at ONWARD cares passionately about our mission, community of patients, and our colleagues.

About the job

The Senior Hardware System Engineer will have to work on the company’s Neuromodulation franchise (both implantable and external stimulators) for people with spinal cord injury.

This role will perform hardware system design, integration, verification, and validation. It will convert customer requirements into product requirements and interface definitions. Working across all levels of system products, from concept, design, manufacturing, test, installation, operation, maintenance, this position will play a leading role in developing our products.

We have a strong preference for a system engineer with hands-on experience in Active Implantable Medical Devices/Implantable Pulse Generator development.

Responsibilities:

• Design and shape the architecture of hardware solutions in collaboration with your colleagues in the disciplines of electrical/electronics, mechanical, thermal, biocompatibility, and electrical/mechanical biomedical modelling.
• Collaborate closely with the Therapy Development team to develop hardware solutions that fully support our therapy portfolio, addressing identified user needs and requirements.
• Enable iterative system development by leading and executing technical investigations , root cause analysis, and providing feedback on requirement feasibility and system-level trade-offs.
• Full responsibility for development of hardware system features according to the V-model.
• Perform functional analysis to ensure system designs meet requirements.
• Employ DRM (Design for Reliability and Manufacturing) tool sets when required, to include concept engineering, modelling and analysis, sensitivity studies, stress analysis.
• Independently perform tolerance, error budget or other design analysis by extending or adapting existing methodologies.
• Create, review, and execute verification and validation plans and protocols; own this process at the hardware system level and guide it at the hardware subsystem level.
• Define statistical strategy for sample size and evaluation of model-to-experiment match in design characterisation and verification; justify methods to internal & external stakeholders.
• Develop tests with a preference for automation, for continuous use in the development cycle from concept and early characterisation, through verification and re-use in production test.
• Lead, develop and implement design characterisation, Design of Experiment (DoE) and design verification strategies for efficient, complete, and robust testing through report completion and anomaly resolution.
• Participate in risk management activities, DFMEA, and risk mitigation implementation.
• Collaborate, discuss, and review design or decisions with engineers from other disciplines (software, mechanics, electronics, therapy development, clinical).
• Guidance of more junior team members.
• Support regression analysis and provide impact assessment for change requests based on product knowledge and existing verification evidence.
• Lead technical aspects of supplier management to address design for manufacture feedback, ensure understanding of design intent, facilitate joint development ventures , address issues in New Product Introduction/Design Transfer/ramp-up, and follow the full product lifecycle.

What we are looking for

• 7 + years relevant industry experience, preferably active implantable medical devices
• Degree in systems engineering, biomedical engineering, electronics engineering, physics
• Deep practical experience with the application of medical device standards such as IEC 60601 & ISO 14708
• Solid background in system development
• Development of test systems and test automation
• Good programming skills (ideally Python)
• Strong understanding of medical device regulation including ISO, FDA, GMP and design controls
• Good understanding of statistics and the statistical analyses necessary to determine tolerance/confidence intervals, product and process capability, process control and the evaluation of acceptance criteria for design characterization and verification
• Model Based System Engineering practitioner (highly desirable but not essential)
• Capable and comfortable with working in a strictly regulated environment, where product development is subject to internal standards applicable to medical device development.
• A team player who can collaborate well with other engineers with varying levels of experience.
• Ability to work in a matrixed and geographically and culturally diverse organization
• Comfortable with ambiguity in the early phases of development, discussion, and resolution of system-level trade-offs to ensure rapid learning and development in a Lean/Agile environment
• Results oriented, hands-on and thrives well in an innovative, fast-paced and performance driven organization.
• Represents the ONWARD CODE (values).

Please click here to apply.