Saluda Medical Hiring for Sustaining Engineer at Bloomington, MN 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 commercialization of data-driven, personalized therapies for patients with chronic pain. ing to the Director of New Product Introduction & Process Excellence, the primary role of this position is to

support commercial products by providing technical expertise and ownership of product design and manufacturing changes at 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 products to assist with successful completion and timely delivery of: 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 ing on the activities related to introducing changes in product or production processes initiated by Saluda or its manufacturing partners
• To perform, document and/or review engineering activities such as design verification, process validation, engineering changes
• To coordinate the ing of production-related issues, assist with investigations and problem resolution, and support or manage the implementation of related product or process changes
• To identify product obsolescence risks or improvement opportunities, and assist with the implementation of these changes
• 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
• Electrical hardware development/manufacturing background
• 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 with experience in Class III implantables.
• 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.