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Principal Quality Design Assurance Engineer
Saluda Medical. Provide technical leadership and strategic direction for Design Assurance activities across product development, sustaining engineering, and post-market programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Design Control and Risk Management within the medical device industry, with a strong focus on regulatory compliance, quality leadership, and strategic oversight of product development processes. Proven ability to mentor cross-functional teams and drive continuous improvement initiatives to enhance product quality and efficiency.
Highest-signal resume keywords
Design Control ExpertiseRisk Management ExpertiseISO 13485 KnowledgeFDA QMSR KnowledgeMedical Device Industry Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Design ControlRisk ManagementQuality StrategyVerification and ValidationStatistical MethodologiesRegulatory ComplianceRisk AnalysisBenefit-Risk EvaluationProcess ImprovementQuality Leadership
Soft Skills
Good Communication SkillsAnalytical SkillsTeam-OrientedFlexible AttitudeAbility to Manage Multiple Priorities
Industry Keywords
ISO 1497121 CFR 820Medical Device FirmwareMedical Device SoftwareMedical Device Cybersecurity
Tech Stack
Tools & technologiesCyber Security
About the role
Key responsibilities & impact- Provide technical leadership and strategic direction for Design Assurance activities across product development, sustaining engineering, and post-market programs
- Serve as subject matter expert for design control and risk management
- Lead quality strategy and risk-based decision making for complex development projects
- Guide and mentor cross-functional teams in planning and executing design control and risk management activities throughout the product lifecycle
- Lead and facilitate ISO 14971 risk management activities, including risk analyses, benefit-risk evaluations, and risk control effectiveness assessments
- Maintain current knowledge of regulatory compliance requirements for product design, development, transfer, and commercialization
- Review, approve, and provide strategic oversight for Design and Development File deliverables and critical product development documentation
- Provide quality leadership during design reviews and assess product and process readiness
- Establish and promote Design Control best practices, tools, methodologies, and process improvements
- 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 in interactions with regulatory authorities, notified bodies, auditors, and external partners
- Mentor, coach, and develop Design Assurance, Quality, and Engineering personnel
- Influence organizational quality strategy through quality system development and strategic planning
- Provide expert guidance on FDA QMSR, ISO 13485, ISO 14949, and other applicable standards
- Lead quality assessments for significant design and process changes, ensuring verification, validation, and regulatory considerations are addressed
Requirements
What you’ll need- 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: Design assurance experience in medical device firmware
- Desirable: Design assurance experience in medical device software
- Desirable: Medical device cybersecurity experience