Company Overview:
Saluda is a global healthcare company that is redefining Spinal Cord Stimulation (SCS) therapy at the intersection of automated algorithms, real-time diagnostics, and ground-breaking clinical evidence. The Saluda difference is defined by Dose-Control Technology via measurement of physiological response.
At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain.
The Role:
This position is based in Minneapolis, and reports to the Senior Manager, Electrical Engineering, who is based in Sydney. The primary role of this position is to provide cross-functional project experience, EMC technical support and compliance governance across all Saluda products. The role is focused on owning EMC compliance but covers all aspects of the product development lifecycle including green field developments, understanding problems in existing designs, making improvements, testing during development and production testing.
Responsibilities:
- Being the subject-matter-expert for the RF and EMC design and compliance for Saluda’s products
- Providing technical input into multi-disciplinary project teams
- Providing regular updates to Project Managers on progress and risks
- Working with external test partners and contract manufacturers to ensure designs meet specification, industry standards and regulatory requirements
- Electrical component selection, schematic design updates, PCB layout, building prototypes and evaluating performance and documenting of results
- Writing test plans and test procedures
- Conducting and documenting verification and process validation activities
- Sustaining engineering activities for existing design
- Development of test systems for design verification and production
- Documentation of changes, submitting change requests and reports
- Lead initiatives to implement changes in requirements, testing or ‘best practice’ to help improve processes and methodologies
Requirements:
- Degree qualified in Electrical Engineering, Telecommunications or similar technical discipline
- A minimum of 8 years’ experience in cross-functional project teams, EMC and RF design
- Experience with electrical RF and EMI standards and compliance testing for CE marking and FCC compliance
- Knowledge of medical device regulatory requirements and standards (ISO 13485, 62304, 14708, 60601-1, etc.)
- Experience in compliance testing with test partners such as TuV or UL
- Self-starter with good self-management skills and exceptional documentation skills
- Strong debugging and problem-solving skills
- Strong programming fundamentals, at embedded level (e.g. C) as well as higher levels of abstraction (e.g. Python, C#)
- Proficiency using schematic and PCB layout packages (e.g. Altium)
- Proficiency using electrical modelling and simulation software such as LTspice.
Desirable Requirements:
- Experience with Bluetooth system design and associated compliance testing
- Experience with Test Method Validation and FMEA
- Experience in the development of medical device test systems (for verification and/or production)
Ideal Candidate Profile
- Keen problem solver
- Strong writing skills
- Positive attitude, ability to form strong relationships with key stakeholders and self-manage
- Understands and accepts the complexities of working in a highly regulated environment
- Ability and desire to work independently and remotely with a core team based in Sydney
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.
Saluda Medical does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Saluda Medical’s approved agency list. Unsolicited resumes or candidate information submitted to Saluda Medical by search/recruiting agencies not already on Saluda Medical’s approved agency list shall become the property of Saluda Medical.
