Engineering - Sr Engr, R&D

Cynet Systems•Irvine, CA

3d•Onsite

About The Position

The Senior Engineer, R&D Sustaining Engineer supports lifecycle management of on-market Class III medical devices. The role investigates field and manufacturing issues, implements design and process improvements, supports engineering change assessments, and helps ensure continued product safety, performance, reliability, manufacturability, and regulatory compliance. It involves hands-on technical problem solving, cross-functional collaboration, and ownership of products after commercial release. The successful candidate applies engineering judgment, data analysis, design control principles, risk management practices, and verification and validation methods to support product improvements and maintain high standards of quality and performance. This is an on-site role at the company’s corporate headquarters in Irvine, California, and the selected candidate must reside in the local region.

Requirements

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

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 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 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 design 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; assess hazards, risk controls, and mitigation, verification, or validation needs arising from issues and changes.
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 engineering change, investigation, technical report, test, risk, and change control documentation in compliance with regulatory requirements and company standards.
Collaborate with quality and regulatory teams to address regulatory requests.
Work with manufacturing, quality assurance, regulatory affairs, clinical development, suppliers, and other engineering teams on product lifecycle management and 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 appropriate measures to prevent injuries, protect the environment, and prevent pollution within their span of influence or control.
Perform other duties as assigned.