Principal Quality Design Assurance Engineer

Regulatory Jobs; United States; Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

Saluda Medical is seeking a Principal Design Assurance Engineer to define and drive design controls, risk management, and regulatory compliance across the product lifecycle. The role partners with R&D, Regulatory Affairs, Manufacturing, and Operations to ensure safety, efficacy, reliability, and post-market support for the Evoke System, with senior leadership interaction and strategic quality initiatives.

This is a senior, highly autonomous role requiring strong communication and mentoring of

Qualifikationen

• 10+ years of design control experience in medical devices.
• Strong knowledge of ISO 13485, ISO 14971 and 21 CFR 820.
• Ability to lead cross-functional teams and influence senior leadership.

Aufgaben

• Provide technical leadership for design assurance across development and post-market programs.
• Lead risk analyses and risk control effectiveness assessments per ISO 14971.
• Mentor cross-functional teams in design controls and quality practices.
• Represent Quality in regulatory interactions and audits.
• Drive continuous improvement of quality systems and processes.

Kenntnisse

Design controls

Risk management

Regulatory compliance

Quality systems

Cross-functional leadership

Ausbildung

Bachelor's degree 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.

Saluda Medical’s first product, the Evoke® System, is designed to deliver known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window.

The Principal Design Assurance Engineer is a senior Quality Engineering role responsible for defining, driving, and continuously improving new product development and supporting sustaining engineering and post-market activities. This role serves as a subject matter expert in design assurance, risk management, design controls and product lifecycle quality, providing strategic guidance to cross-functional teams, technical leaders and senior leadership. The Principal Design Assurance Engineer ensures compliance with global regulatory requirements and industry standards while driving the effective implementation of quality engineering principles throughout product development and commercialization.

The role provides oversight of critical design and risk management decisions, mentors engineering and quality professionals, and influences the development of quality systems, processes, and best practices across the organization. The Principal Design Assurance Engineer partners closely with R&D, Clinical, Regulatory Affairs, Manufacturing, and Operations teams to ensure products meet safety, efficacy, reliability, and compliance requirements throughout the product lifecycle.

Accountabilities and Associated Responsibilities:

• Provide technical leadership and strategic direction for Design Assurance activities across product development, sustaining engineering, and post-market programs.
• Subject matter expert for design control and risk management.
• Lead quality strategy and risk-based decision making for complex development projects, ensuring alignment with business objectives and regulatory requirements.
• Guide and mentor cross-functional teams in the planning and execution of design control and risk management activities throughout the product lifecycle.
• Lead and facilitate risk management activities in accordance with ISO 14971, including risk analyses, benefit-risk evaluations, and risk control effectiveness assessments.
• Maintain up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities.
• Review, approve, and provide strategic oversight for Design and Development File deliverables and critical product development documentation.
• Provide quality leadership during design reviews, ensuring robust assessment of product and process readiness.
• Establish and promote Design Control best practices, tools, methodologies, and process improvements across the organization.
• Lead investigations and resolution of complex product quality, reliability, and compliance issues.
• Drive continuous improvement initiatives to enhance product quality, development efficiency, and regulatory compliance.
• Provide technical oversight and approval of verification and validation strategies, protocols, reports, and statistical methodologies.
• Represent Quality during interactions with regulatory authorities, notified bodies, auditors, and external partners as required.
• Mentor, coach, and develop Design Assurance, Quality, and Engineering personnel, fostering technical excellence and quality culture across the organization.
• Influence organizational quality strategy through participation in quality system development, and strategic planning initiatives.
• Provide expert guidance on the application of FDA QMSR, ISO 13485, ISO 14971 and other applicable standards.
• Lead quality assessments for significant design and process changes, ensuring appropriate verification, validation, and regulatory considerations are identified and addressed.

Essential Requirements:

• Bachelor’s degree or higher in a technical field (Biomedical, Mechanical, Electrical, Software 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, including senior leaders
• Ability to manage multiple priorities and work with ambiguity
• Must be able to work independently under minimal supervision
• Strong analytical skills
• More than 10 years experience in Design Control in the medical device industry

• Design Control and Risk Management expertise in the medical device industry

• Expert knowledge of ISO 13485, ISO 14971, 21 CFR 820
• Ability to represent the company externally with regulators, auditors, standards bodies, and strategic partners

Desirable Requirements:

• Design assurance experience in medical device firmware
• Design assurance experience in medical device software
• Medical device cybersecurity experience