Sustaining Engineer

408 – Sustaining Engineering            ·               Bloomington, Minnesota            ·             Full time

Saluda Medical is a global medical device company focused on patient outcomes, science, and engineering to transform the neuromodulation industry through the development and commercialisation of data-driven, personalised therapies for patients with chronic pain. Reporting to the Director, New Product Introduction & Process Excellence, the primary role of this position is to drive commercial manufacturing and operations initiatives through contract manufacturers to ensure supply continuity and quality system requirements. This role works with a broader team of Supply Chain, Quality, and Regulatory to maintain products through ongoing improvements and focused initiatives to improve patient experiences.

Accountabilities and Associated Responsibilities:

• To liaise with manufacturers of Saluda’s product components to assist with successful completion and timely delivery of: product development and sustaining project goals, production process implementation activities and production output targets
• Foster strong working relationships with Saluda’s manufacturing partners as well as internal team members and work to optimise productivity
• To assist with the planning, execution and reporting on the activities related to sustaining projects Saluda or its manufacturing partners
• To coordinate cross-functional input to develop commercialization strategy and raise awareness to cross-functional peers when issues impact project.
• Ensure procedures per Saluda’s Quality System are followed
• Execute and/or drive execution of deliverables to support Product Development Lifecycle.
• Establish subject-matter-expertise on effective change management within an ISO13485, EU MDR and FDA CFR compliant system.
• Follow and improve Saluda’s Quality Management System.
• Travel to supply chain locations
• Other duties as required

Essential Requirements:

• 7 years engineering experience with a minimum of 5 years’ experience with medical devices, product / process development, or sustaining engineering
• Sustaining operations background (manufacturing site transfers, COGS initiatives)
• 3 years supervising technicians or engineers in a regulated manufacturing or product development environment.
• Ability to conduct and direct projects in a regulated industry, preferably under ISO 13485 and regulatory bodies (eg. FDA, TGA, CE Mark) compliant design and development procedures
• Understanding of medical device product development lifecycle under a compliant QMS
• Proven collaboration skills with external supply chain partners
• 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 equivalently relevant field)
• Demonstrated ability to liaise with external parties and represent the company’s interests

Desirable Requirements:

• 10 years engineering experience with medical devices, product / process development, or sustaining engineering.
• Ability to diligently advance projects under regulatory oversight by FDA, TGA, Notified Bodies, and other government officials.
• Experience with Solidworks CAD software 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

Saluda Medical embraces diversity and equal opportunity in a serious manner. 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. The more inclusive we are, the better our work will be.

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.

Please click here to apply.