Sustaining Engineer II

Sustaining Engineers collaborate with cross-functional teams to support released Cardio Quip products throughout the post-market lifecycle. Responsibilities include product and process changes, design transfer, complaint investigations, manufacturing support, post-market data review, product improvement, and maintenance of compliant engineering and quality documentation.

• Independently execute routine lifecycle-management and post-market maintenance activities for released Cardio Quip 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 Cardio Quip 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.

• Completed a 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.

• Experience with design controls, design history and technical documentation, change control, risk management, RCA, FMEAs, CAPA, design verification and validation, process validation, statistical methods, and risk-based design.
• Experience supporting released products through design changes, manufacturing investigations, supplier changes, design transfer, or other sustaining-engineering activities.
• Knowledge of manufacturing processes, engineering drawings and bills of material, DFM/DFA/DFS, and production problem solving.
• Knowledge of and experience with medical-device regulations and standards, such as FDA QMSR, 21 CFR Part 803, ISO 13485, ISO 14971, EU MDR, IEC 60601, IEC 62304, and IEC 62366, as applicable.
• Ability to analyze technical and post-market data, exercise sound engineering judgment, and translate findings into appropriate recommendations.
• Ability to lead routine project planning, scheduling, budgeting, and tracking efforts; excellent organizational, technical writing, oral, and interpersonal skills.

• Competitive Compensation
  • A fair salary commensurate with experience and qualifications.
• Comprehensive Benefits
  • Health, dental, and vision insurance.
  • Retirement savings plan with company contribution.
• Dynamic Work Environment
  • A supportive team culture that values innovation, improvement, and empowerment.
• Work-Life Balance
  • Paid time off, including vacation days and holidays.
• Fun and Engaging Culture
  • We believe in working hard and celebrating our successes together, fostering a sense of camaraderie and…