Senior Engineer, R&D Sustainment
Location:
Irvine, CA (On-site)
Schedule:
Standard
Duration:
6 Month Contract
Pay Range:$51.50-56.50/hr - W2 only
Our client, a medical device organization, is seeking a Senior Engineer, R&D Sustainment to support the lifecycle management of on-market Class III implantable medical devices. Working alongside Quality and Manufacturing teams, you will investigate field and manufacturing issues, implement design and process improvements, and support engineering change assessments. Your work will help ensure continued product safety, performance, reliability, manufacturability, and regulatory compliance for devices that improve outcomes for patients with heart failure.
Job Responsibilities:
In this role, you will manage and support a variety of projects within the R&D Engineering department, focused on the post-market sustainment of Class III implantable devices. Key responsibilities include:
Essential Job Duties and Job Functions:
- Issue Resolution and Root Cause Investigation: Lead investigations into device field issues by analyzing product performance data, customer feedback, and failure reports. Define and execute engineering studies and testing to determine root cause and support effective actions that minimize device downtime and customer impact.
- Design and Process Improvement: Partner with R&D and Manufacturing to identify and lead design changes and process improvements that enhance device reliability, performance, and manufacturability.
- Product Performance Monitoring: Monitor device performance and quality metrics, and develop and execute plans to address deviations from expected performance.
- Design Changes and Change Control: Lead design and process changes for on-market devices, including design impact assessments, documentation, requirements and specification updates, verification planning, change control implementation, and assessment of labeling and risk impacts.
- Risk Management: Lead updates to design FMEAs, hazard analyses, and risk management files. Evaluate whether issues or changes introduce new hazards, affect existing risk controls, or require additional mitigation, verification, or validation.
- Verification and Validation (V&V): Develop, review, and execute test plans, protocols, reports, and test methods to support product changes, manufacturing improvements, complaint investigations, CAPAs, and regulatory responses. Analyze results using appropriate engineering and statistical methods to ensure objective evidence supports design change decisions.
- Documentation and Compliance: Maintain accurate, comprehensive records of engineering changes, investigations, technical reports, test records, risk documentation, and change control. Ensure compliance with regulatory requirements and company standards, and collaborate with Quality and Regulatory on regulatory requests.
- Cross-Functional Collaboration: Work closely with Manufacturing, Quality Assurance, Regulatory Affairs, Clinical Development, suppliers, and other engineering teams to support product lifecycle management.
- Assign R&D support tasks and train, coach, and guide lower-level employees on routine procedures.
- Perform other duties as assigned.
Knowledge and Skills:
- Experience with ISO 13485, ISO 14971, FDA quality management system regulations, and applicable medical device regulatory expectations
- Experience developing or executing verification and validation protocols, engineering test methods, and technical reports
- Working knowledge of medical device design controls, change control, CAPA, complaint investigations, and risk management
- Proficiency in engineering software and statistical tools for design and data analysis, in particular Python, Minitab, and Excel
- Experience with CAD, engineering specifications, tolerance analysis, and hardware design documentation (preferred)
- Strong written and verbal communication skills, with the ability to document technical rationale and present findings to cross-functional stakeholders
- Solid problem-solving, organizational, analytical, and critical thinking skills
- Attention to detail and commitment to high-quality documentation
- Ability to work effectively in a team-oriented, fast-paced, regulated environment while managing multiple priorities
- Adherence to all company rules and requirements, including Environmental Health & Safety rules, and use of appropriate control measures to prevent injury and protect the environment
Education and Experience:
- Bachelor’s Degree in Engineering or a Scientific field with 4 years of experience, OR Master’s Degree or equivalent in Engineering or a Scientific field with 3 years of experience, OR Ph.D. or equivalent in Engineering or a Scientific field
- Experience supporting on-market medical devices, preferably Class III implantable or electromechanical devices (preferred)
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