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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading design control activities and ensuring compliance with medical device standards, including ISO 13485 and IEC 62304. Proficient in software verification and validation processes, risk management, and quality management systems within regulated environments.
Highest-signal resume keywords
Design Control ManagementSoftware Verification And ValidationQuality Management SystemsRegulatory ComplianceRisk Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Software Development LifecycleDesign Input And OutputVerification And Validation StagesConfiguration ManagementChange ControlUsability EngineeringCybersecuritySoftware Tools ValidationAnomaly HandlingTraceability Management
Soft Skills
LeadershipMentoringOrganizational SkillsCommunication SkillsTeam Collaboration
Tools & Technologies
Electronic QMS ToolsQuality MetricsCAPAGMPInternal Audits
Certifications & Qualifications
CQECQMCertified Lead AuditorCertified Internal Auditor
Industry Keywords
Medical Device IndustryIEC 62304ISO 13485FDA 21 CFR 820EU MDRMDSAPISO 14971Software As A Medical DeviceRisk-Based Computer Software Assurance21 CFR Part 11
Tech Stack
Tools & technologiesCyber Security
About the role
Key responsibilities & impact- Lead and support design control activities for R&D projects, especially software development, from Design Planning through Transfer to Production
- Ensure execution of design input, design output, verification and validation stages, including software requirements, architecture, verification, validation and traceability
- Review and approve R&D and technical documentation, procedures, protocols and reports, emphasizing software lifecycle deliverables
- Support software development lifecycle processes under IEC 62304, including software classification, risk management, anomaly handling, configuration management and release
- Support validation of software tools used in the QMS and R&D, including development, testing, requirements, traceability management and electronic QMS tools, under ISO 13485 and FDA guidance
- Integrate usability engineering, cybersecurity and software risk management into design controls and risk management files
- Support change control for R&D-related products and Life Cycle Management products, including software changes and releases
- Review and approve Quality-related procedures and documentation
- Support annual quality plan activities, Management Review, quality metrics and QA compliance KPIs
- Lead internal audits and participate in external audits
- Support Complaints handling process activities as the design control point of contact
- Operate within medical device standards including ISO 13485, FDA 21 CFR 820 (QMSR), MDSAP, EU MDR, ISO 14971 and IEC 62304
Requirements
What you’ll need- Bachelor’s degree in engineering, science or technical field or equivalent
- Minimum 7 years of experience in the highly regulated multidisciplinary medical device industry in Quality, R&D or Regulatory roles with direct responsibility for Design Controls
- Hands-on experience in medical device R&D environments with multidisciplinary software, hardware, systems and clinical development teams throughout the product development lifecycle
- Experience in medical device software quality, including Software as a Medical Device (SaMD), software development lifecycle, software verification and validation
- Experience supporting software tools validation in a regulated environment, including risk-based computer software assurance (CSA) and 21 CFR Part 11
- Strong knowledge of Quality Management Systems, Design Controls, GMP, Risk Management, Internal Audits, CAPA, Change Control and Documentation Controls
- Working experience with ISO 13485:2016, FDA 21 CFR 820 (QMSR), EU MDR, MDSAP, ISO 14971, IEC 62304 and IEC 62366-1
- Ability to teach, develop and mentor employees
- Process detailed and results oriented
- Ability to work in a fast-paced team environment in line with company values
- Well organized, with ability to deliver results on several projects simultaneously
- Strong oral and written communication skills
- Professional level of English
- Master’s degree preferred
- Experience with regulated high-risk-class medical devices and IEC 62304 Class B/C software advantageous
- CQE, CQM or equivalent certification advantageous
- Certified Lead/Internal Auditor advantageous
Benefits
Comp & perks- Full-time employment
- Hybrid work arrangement in Haifa / remote Israel