Sustaining Engineer II - Medical Devices (Post-Market)

Socket.dev; College Station (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Health, dental, vision insurance

Retirement plan

Job summary

CardioQuip is hiring a Sustaining Engineer to support released cardiovascular devices through maintenance, design transfers, and post-market activities. You will lead investigations, analyze field data, and coordinate CAPAs, ensuring compliance and product continuity.

The role emphasizes cross-functional collaboration, documentation discipline, and ongoing process improvements in a regulated environment. On-site position with competitive benefits and professional growth opportunities.

Qualifications

• Bachelor's degree in a relevant engineering field.
• At least 1 year of relevant industry experience.
• 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

Education

Bachelor's degree in engineering

Job description

CardioQuip is hiring a Sustaining Engineer to support released cardiovascular devices through maintenance, design transfers, and post-market activities. You will lead investigations, analyze field data, and coordinate CAPAs, ensuring compliance and product continuity.

The role emphasizes cross-functional collaboration, documentation discipline, and ongoing process improvements in a regulated environment. On-site position with competitive benefits and professional growth opportunities.