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.

Saluda Medical

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Senior RF and Compliance Engineer