Senior R&D Engineer

TalentBurst•Irvine, CA

1d•Onsite

About The Position

The Senior Engineer, R&D Sustaining Engineer supports lifecycle management of on-market Class III medical devices by investigating field and manufacturing issues, implementing design and process improvements, supporting engineering change assessments, and ensuring continued product safety, performance, reliability, manufacturability, and regulatory compliance. The role applies engineering judgment, data analysis, design control principles, risk management practices, and verification and validation methods to product improvements and sustaining engineering. The position is part of an R&D team working with Quality and Manufacturing on medical innovations for structural heart disease, including the Implantable Heart Failure Management team. It is based 100% onsite at the corporate headquarters in Irvine, California; the selected candidate must reside in the local region. The position is a contract of at least six months, with a high possibility of extension. The role also assigns R&D support tasks and trains, coaches, and guides lower-level employees on routine procedures. The employee must follow company rules and requirements, including Environmental Health and Safety measures, and take appropriate steps to prevent injuries and protect the environment.

Requirements

Bachelor's degree in an engineering or scientific field and 4 years of experience, or a master's degree or equivalent in an engineering or scientific field and 3 years of experience, or a Ph.D. or equivalent in an engineering or scientific field.
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.

Nice To Haves

Experience supporting on-market medical devices, preferably Class III implantable or electromechanical devices.
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, particularly Python, Minitab, and Excel.
Strong written and verbal communication skills, including the ability to document technical rationale and present findings to cross-functional stakeholders.
Experience with CAD, engineering specifications, tolerance analysis, and hardware design documentation.
Strong 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.

Responsibilities

Lead investigations of device field issues by analyzing product performance data, customer feedback, and failure reports.
Define and execute engineering studies and testing to determine root causes and support effective corrective actions that minimize device downtime and customer impact.
Collaborate with R&D, manufacturing, and other cross-functional teams to identify and implement design changes and process improvements that enhance device reliability, performance, and manufacturability.
Monitor device performance and quality metrics, and develop and execute plans to address deviations and sustain product performance.
Lead design and process changes for on-market medical devices, including impact assessments, documentation and requirements updates, verification planning, change control implementation, and assessment of potential labeling and risk impacts.
Lead risk management activities, including updates to design FMEAs, hazard analyses, and risk management files.
Evaluate whether issues or design and process changes introduce hazards, affect existing risk controls, or require additional mitigation, verification, or validation.
Develop, review, and execute engineering test plans, protocols, reports, and test methods supporting product changes, manufacturing improvements, complaint investigations, CAPAs, and regulatory responses.
Analyze test results using appropriate engineering and statistical methods and ensure objective evidence supports technical conclusions and design change decisions.
Maintain accurate documentation of engineering changes, investigations, technical reports, test records, risk documentation, and change control activities.
Ensure activities comply with regulatory requirements and company standards, and collaborate with Quality and Regulatory teams on regulatory requests.
Work with manufacturing, quality assurance, regulatory affairs, clinical development, suppliers, and other engineering teams to support product lifecycle management and effective implementation of engineering solutions.
Assign R&D support tasks and train, coach, and guide lower-level employees on routine procedures.
Follow company rules and requirements, including Environmental Health and Safety rules, and take adequate control measures to prevent injuries and protect the environment and prevent pollution.
Perform other duties as assigned.