Electrical Engineer - Hardware Product, Sustaining

Saluda Medical - Minneapolis, MN

Full-time

Minneapolis, MN

Administrative and Support Services

About the position

The position at Saluda Medical focuses on providing technical expertise and ownership of product design and manufacturing changes for commercial products, ensuring supply continuity and adherence to quality system requirements. The role involves collaboration with various teams to maintain and improve products, ultimately enhancing patient experiences.

Responsibilities

• Liaise with manufacturers to assist with the successful completion and timely delivery of sustaining project goals and production process implementation activities.
• Foster strong working relationships with manufacturing partners and internal team members to optimize productivity.
• Be accountable for product engineering from design transfer through end of life for parts of Saluda's Evoke system.
• Perform, document, and review engineering activities such as design verification, process validation, and engineering changes.
• Coordinate the reporting of production-related issues, assist with investigations and problem resolution, and support or manage the implementation of related product or process changes.
• Identify product obsolescence risks or improvement opportunities and assist with the implementation of these changes.
• Follow and improve Saluda's Quality Management System.

Requirements

• 7 years engineering experience with a minimum of 5 years' experience with medical devices, product/process development, or sustaining engineering.
• Electrical hardware development/manufacturing background.
• Proven collaboration skills with external supply chain partners.
• Strong written and verbal communication skills to clearly explain change and risk.
• Mindset to get things done in an emerging company.
• Bachelor's degree in Engineering or a relevant field.
• Demonstrated ability to liaise with external parties and represent the company's interests.

Nice-to-haves

• Experience with Class III medical devices.
• Ability to advance projects under regulatory oversight by FDA, TGA, Notified Bodies, and other government officials.
• Experience with Altium PCB Design, Solidworks CAD, and statistical analysis software (e.g. Minitab, JMP).
• Familiarity with neuromodulation, lead manufacturing, IPG manufacturing, DOE, IQ/OQ/PQ, measurement system analysis, and sterile barrier packaging with UDI labels.
• Working knowledge of regulatory requirements.