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Design Assurance Engineer
Saluda Medical. Support new product development, sustaining engineering, and post-market activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality engineering, product development, and regulatory compliance, with a strong focus on risk management and design control processes. Capable of mentoring teams and collaborating effectively across functions to ensure successful product commercialization.
Highest-signal resume keywords
Quality Engineering SupportRisk ManagementDesign ControlRegulatory ComplianceCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
FMEAProduct VerificationProduct ValidationDesign Change ControlTest Method ValidationRisk AnalysisProduct Requirements DevelopmentDesign Verification Test PlansDesign Verification ProtocolsDesign Verification Reports
Soft Skills
Good Communication SkillsTeam-OrientedFlexible AttitudeAnalytical SkillsAbility to Manage Multiple Priorities
Certifications & Qualifications
FDA Regulations TrainingISO Standards Training
Industry Keywords
Biomedical EngineeringMechanical EngineeringElectrical EngineeringDHF DocumentationPost-Market ActivitiesProduct DesignSustaining EngineeringCross-Functional TeamsQuality DisciplinesCommercialization
About the role
Key responsibilities & impact- Support new product development, sustaining engineering, and post-market activities
- Provide quality engineering support to cross-functional teams
- Ensure compliance with design controls and production and process controls
- Support development of product requirements, product verification and validation, risk management, and design change control
- Identify and implement effective design controls from concept through commercialization
- Support product design and design changes through cross-functional collaboration
- Mentor cross-functional teams on product development, design control, and risk management deliverables
- Complete risk analysis studies using FMEA and other risk management tools
- Maintain current knowledge of regulatory compliance requirements for product design, development, transfer, and commercialization
- Represent Quality by supporting quality disciplines, decisions, and practices
- Liaise with internal and external departments
- Support changes to DHF documentation
- Review and approve design verification test plans, protocols, and reports
- Develop test method validation requirements
Requirements
What you’ll need- 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)
Benefits
Comp & perks- Equal opportunity and commitment to diversity
- Team-oriented, collaborative work environment
- Opportunity to work on innovative medical device technology and neuromodulation treatments