Engineering · Full-time · MN, United States
About Saluda Medical
Saluda Medical was founded in 2013 for the purpose of transforming patients’ lives with disruptive neuromodulation solutions. We are leaders in the field with proven exceptional pain management results and, with more than 10 years of advanced research development and clinical experience, we design and develop advanced neuromodulation systems for the next generation of implantable stimulation devices.
What We’re Looking For...
Reporting to the Senior Manager, Electrical Engineering, who is based in Sydney, this role will provide cross-functional project experience and technical product support to contract manufacturers based in the US. The role has a strong focus on automated test system development and validation and would be ideal for someone with a broad skill set spanning electronics, software and mechatronics and a background in medical device development.
Your role will include...
As part of a team, design and develop hardware and firmware for active implantable medical products and test equipment
Liaise with external contract manufacturers and provide product-specific knowledge to aid the development of manufacturing test systems
Work with external test partners to ensure designs meet specification, industry standards and regulatory requirements
Conduct verification and process activities, including writing protocols and reports
Lead initiatives to implement changes in requirements, testing or ‘best practice’ to help improve processes and methodologies
Produce and develop documentation in line with Saluda’s QMS for purposes of requirements development, design, verification, manufacture and sustaining of Saluda's products, including:
planning & implementing changes following the change control procedure
engaging collaborators and reviewers to address and resolve issues and minimise delays in review and approval processes.
Provide regular updates to Project Managers on progress and risks
Attend global team meetings outside of regular business hours
Other duties required from time to time directed by your manager
About you...
Exceptional written and verbal communication skills
Ability and desire to work independently and remotely with a core team based in Sydney
Ability to handle multiple priorities and develop strong relationships with fellow employees and suppliers, both locally and internationally
Strong debugging and problem-solving skills
Bachelor’s degree or higher in Electronic, Electrical Engineering
Minimum of 5 years’ experience in the specification, design and development of electronic hardware and/or firmware for medical applications
Knowledge of medical device regulatory requirements and standards (ISO 13485, 62304, 14708, 60601-1, etc.)
Strong programming fundamentals, at embedded level (e.g. C) as well as higher levels of abstraction (e.g. Python, C#)
Experience with Test Method Validation and FMEA
Ability to read and interpret schematics and datasheets
Experience with and commitment to product development in a QA controlled environment
Self motivated with excellent time management skills
Its not essential, but it's nice if you have...
Experience in the development of medical device test systems (for verification and/or production)
Experience with Bluetooth (or other RF) system design and associated compliance testing
PCB Design with Altium
Proficiency using electrical modelling and simulation software such as LTspice.
Knowledge of control systems, digital signal processing, and neurophysiology
At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt.
Are you Ready to Join? If you would like to be part of our team developing the world's next generation of implantable device technology, contribute to making an impact on patient care, then this is the opportunity for you! Please APPLY NOW!
Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation