Senior Staff Sustaining Engineer, Medical Devices

BioTalent; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

BioTalent is seeking a Staff or Senior Staff Sustaining Engineer for a medical devices program. You will own complex product issues end to end, from complaints to CAPAs, field problems, and supplier changes, coordinating across Quality, Manufacturing, Regulatory, Supply Chain and R&D.

You will lead investigations, drive RCAs, implement changes with risk assessments and V&V, and oversee design verification and validation activities to support regulatory submissions.

Qualifications

• BS or higher in Mechanical, Biomedical, Materials, Manufacturing or related engineering.
• 8+ years of experience for Staff, 10+ for Senior Staff.
• Experience with sustaining, product, manufacturing or quality engineering on commercial devices.

Responsibilities

• Lead sustaining engineering for commercial devices.
• Investigate and resolve complaints, field issues, manufacturing problems and customer escalations.
• Lead CAPA, root-cause analysis, corrective actions and effectiveness checks.
• Evaluate and implement material, supplier or process changes with risk assessment and V&V.
• Coordinate biocompatibility, sterility and testing with external labs.
• Perform design verification, validation and process validation for regulatory submissions.
• Analyze data to spot trends and support improvements.
• Mentor engineers and guide cross-functional teams.

Skills

Sustaining engineering

CAPA investigations

Root-cause analysis

Cross-functional leadership

Education

BS or higher in Mechanical/Biomedical/Materials/Manufacturing engineering

Job description

BioTalent is seeking a Staff or Senior Staff Sustaining Engineer for a medical devices program. You will own complex product issues end to end, from complaints to CAPAs, field problems, and supplier changes, coordinating across Quality, Manufacturing, Regulatory, Supply Chain and R&D.

You will lead investigations, drive RCAs, implement changes with risk assessments and V&V, and oversee design verification and validation activities to support regulatory submissions.