Design Assurance Engineer

Saluda Medical; Minnetonka (MN); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Saluda Medical, headquartered in Minneapolis, Minnesota, seeks a Design Assurance Engineer to drive design controls and quality across the product lifecycle from concept to commercialization.

The role supports product development, sustaining engineering, and post-market activities, ensuring DHF and design controls align with regulatory expectations and cross-functional collaboration is strong.

Qualifikationen

• Bachelor's degree or higher in a technical field (Biomedical, Mechanical, Electrical Engineering or other technical field).
• Experience mentoring cross-functional teams in design controls and risk management.
• Knowledge of FDA regulations or ISO standards (preferred).

Aufgaben

• Identify and implement design controls to support product development from concept through commercialization.
• Ensure activities comply with internal and regulatory requirements through cross-functional collaboration.
• Mentor cross-functional teams on design control and risk management deliverables.
• Conduct risk analyses using FMEA and other risk management tools.
• Stay current on regulatory requirements for design, development, transfer, and commercialization.
• Support quality decisions and practices across departments.
• Collaborate with internal and external partners.
• Review design verification test plans, protocols and reports.
• Develop test method validation requirements.

Kenntnisse

Cross-functional teamwork

Independent work

Strong analytical skills

Effective communication

Prioritization under ambiguity

Regulatory awareness (FDA/ISO)

Ausbildung

Bachelor's or higher in a technical field

Jobbeschreibung

Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed‑loop neuromodulation platform. The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real‑time neurophysiological feedback.

SaludaMedical’sfirst product, the Evoke® System, is designed to deliver known,consistent,and personalized spinal cord stimulation therapy by objectively measuring neural responses andmaintainingtherapy within a prescribed therapeutic window.Saluda Medical is headquartered in Minneapolis, Minnesota.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient’s lives.

The Design Assurance Engineer is a quality engineering role that supports new product development, sustaining engineering and post-market activities. This role will provide quality engineering support to cross-functional teams to ensure the application and compliance to design controls and subsequent production and process controls are adequate. Specifically, this role will provide quality engineering support to the development of product requirements, product verification and validation, risk management, and design change control.

What You’ll Do:

• Work on a cross-functional team to identify and implement effective design controls and support product development from concept through commercialization.
• Understanding of Design Assurance requirements to support product design and design changes through cross-functional team collaboration, to ensure activities comply to all internal and regulatory requirements.
• Mentor cross functional teams through product development process; specifically, with respect to design control and risk management deliverables.
• Completes risk analysis studies of design and processes using FMEA and other Risk Management tools.
• Maintain up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
• Represent Quality by supporting quality disciplines, decisions, and practices.
• Liaise with departments, both internally and externally to build strong collaborative partnership.
• Support changes to DHF documentation.
• Review and approve design verification test plans, protocols and reports.
• Develop test method validation requirements.

What You'll Bring:

• Bachelor’s degree or higher in a technical field (Biomedical, Mechanical, Electrical Engineering or other technical field)
• Comfortable working independently and as part of a cross-functional team
• Flexible and positive attitude, team-oriented
• Good communication skills (verbal and written), comfortable speaking and presenting to others
• Ability to manage multiple priorities and work with ambiguity
• Must be able to work independently under limited supervision
• Strong analytical skills
• Training experience to FDA regulations or ISO standards (preferred)

Our Core Values:

• People – Our first responsibility is to the patients we serve.
• Integrity – Do the right thing
• Pioneering – Lead Boldly, Change Lives, Disrupt the Status-Quo
• Performance – Win together – Deliver with Excellence.

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.