Medical Device Sustaining Engineer II – Post‑Market Impact

Cardioquip; College Station (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Health, dental, and vision insurance

Retirement savings plan

Paid time off

Engaging culture

Job summary

CardioQuip is seeking a Sustaining Engineer in Texas to support released products through the post-market lifecycle, manage changes, risk assessment, verifications, and documentation.

You will lead design transfers, analyze post-market data, conduct root-cause investigations, CAPA, coordinate with manufacturing, suppliers, and customers, and help maintain compliance with QMS and regulatory standards.

Qualifications

• Bachelor’s degree in a relevant engineering field.
• At least 1 year of relevant industry experience, preferably in the medical device industry.
• Project management experience or CAPM certification preferred.

Responsibilities

• Independently execute routine lifecycle-management and post-market maintenance activities for released CardioQuip products, including controlled product and process changes from problem definition through technical justification, risk assessment, verification and validation, documentation, and implementation.
• Lead or coordinate routine design transfer activities for new products and product changes, including manufacturing readiness, drawings and bills of material, work instructions, inspection and test methods, training support, and production documentation.
• Analyze post-market, service, manufacturing, complaint, and customer feedback data to identify trends, product issues, and improvement opportunities and recommend appropriate actions.
• Lead routine engineering investigations and root cause analyses for product, manufacturing, service, and complaint issues and implement or coordinate corrective actions.
• Perform complaint handling activities assigned to Engineering, including customer communication, device investigations, complaint determinations and documentation, risk assessments, corrective-action or CAPA evaluations, and domestic and international reportability determinations, regulatory reporting documentation, and approvals, as assigned, authorized, and qualified.
• Plan, draft, execute, and document verification, validation, and process validation activities supporting sustaining changes.
• Conduct routine engineering manufacturing-line audits and observations to verify personnel adherence to approved procedures, work instructions, and manufacturing practices; document findings and coordinate appropriate follow-up.
• Maintain design, manufacturing, risk-management, and change-control records for assigned products in accordance with applicable standards, regulations, and CardioQuip quality requirements.
• Work directly with contract manufacturers, suppliers, Service, distributors, and customers to resolve technical issues, evaluate changes, and support product and supply continuity.
• Coordinate cross-functional sustaining activities and update management and stakeholders regarding project progress, risks, budgets, and timelines.
• Participate in continuous improvement of engineering and sustaining processes and in outreach for prospective engineering talent.
• Other duties as assigned.

Skills

Project management

CAPM certification

Root cause analysis

Data analysis

Communication

Education

Bachelor's degree in engineering

Job description

CardioQuip is seeking a Sustaining Engineer in Texas to support released products through the post-market lifecycle, manage changes, risk assessment, verifications, and documentation.

You will lead design transfers, analyze post-market data, conduct root-cause investigations, CAPA, coordinate with manufacturing, suppliers, and customers, and help maintain compliance with QMS and regulatory standards.