Senior Software Quality Engineer, SaMD | Lead R&D Teams

Brighter Signals; Boston (MA); Sur place; USD 109 000 - 175 000; Plein temps

Avantages offerts par ce poste

Vacation time (PTO)

Sick time

Floating holidays

Parental Leave

Résumé du poste

Johnson & Johnson's DePuy Synthes seeks a Senior Quality Engineer for Product Software Development to lead quality activities on medical device software projects. You will guide requirements, risk assessments, and test strategies, ensuring design controls and defect analysis are robust.

This role includes mentoring engineers, supporting regulatory filings, audits and CAPAs, and ensuring compliance with IEC 62304, FDA guidance, ISO13485, EU MDR, ISO14971, HIPAA, and data security requirements.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems or Biomedical/Bio-engineering is required.
• Minimum of 4 years of regulated industry experience in quality, new product development, or manufacturing engineering.
• Ability to apply quality tools/systems/processes to meet goals and objectives.
• Demonstrated ability to manage multiple projects while meeting deadlines and budgets.

Responsabilités

• Provide quality leadership on medical device software development projects.
• Lead software risk assessments and develop risk management documents.
• Guide project teams on design controls and verification/validation activities.
• Support regulatory filings, inspections, and CAPA activities.
• Mentor and train junior engineers in quality systems.

Connaissances

Quality leadership

Regulated industry experience

Cross-functional collaboration

Software risk assessment

IEC 62304

Formation

Bachelor’s degree in Engineering/Computer Science/Information Systems

Advanced degree preferred

Outils

ASQ Certification (preferred)

Description du poste

Johnson & Johnson's DePuy Synthes seeks a Senior Quality Engineer for Product Software Development to lead quality activities on medical device software projects. You will guide requirements, risk assessments, and test strategies, ensuring design controls and defect analysis are robust.

This role includes mentoring engineers, supporting regulatory filings, audits and CAPAs, and ensuring compliance with IEC 62304, FDA guidance, ISO13485, EU MDR, ISO14971, HIPAA, and data security requirements.