Staff Sustaining Engineer

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

Staff / Senior Staff Sustaining Engineer | Medical Devices

I am partnering with a commercial-stage medical device company to hire a Staff or Senior Staff Sustaining Engineer. You'll be the technical lead keeping a commercial disposable device line reliable, manufacturable and performing well in the field.

THE ROLE

You'll own complex product issues end to end: complaints, CAPAs, field problems, supplier and material changes, and manufacturing issues. You'll lead each one from root cause through closure, working across Quality, Manufacturing, Regulatory, Supply Chain and R&D. The environment moves fast and priorities can shift quickly, so you'll need to be comfortable reprioritizing while keeping ownership.

RESPONSIBILITIES

• Lead sustaining engineering for commercial products
• 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, component, supplier and process changes, including risk assessment and V&V
• Drive biocompatibility, sterility and sterile barrier testing, coordinating with external test labs
• Perform design verification, design validation and process validation, and prepare documentation for regulatory submissions
• Analyze complaint, manufacturing and field data to spot trends early
• Support product improvements, cost reductions, supply continuity and obsolescence management
• Maintain specifications, drawings, risk files and test methods
• Mentor engineers and guide cross-functional teams

QUALIFICATIONS

• BS or higher in Mechanical, Biomedical, Materials, Manufacturing or related engineering
• 8+ years of experience for Staff, 10+ for Senior Staff
• Broad sustaining, product, manufacturing or quality engineering experience on commercial products
• Strong track record with CAPA, root-cause investigations, complaints and field issues
• Experience implementing material, supplier or process changes
• Proven ability to lead cross-functional issues to closure
• Experience in a regulated development or manufacturing environment

PREFERRED

• Disposable or single-use medical device experience
• ISO 13485, FDA QSR, design controls and risk management
• Polymers, adhesives, molded components, assemblies or packaging