Senior R&D Engineer

Position: Senior R&D Engineer, Req# 20042-1

Client's internal title: Senior Engineer, R&D Sustaining Engineer

Location: Irvine, CA (100% onsite)

Duration: 6+ month contract with a high possibility of extension

Job Description:

Innovation starts from the heart. At Client, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world.

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This is an on-site role based at our corporate headquarters in Irvine, CA. The selected candidate must reside in the local region.

How you will make an impact:

The Senior Engineer, R&D Sustaining Engineer will support 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 is ideal for an engineer who enjoys hands-on technical problem solving, cross-functional collaboration, and ownership of products after commercial release. The successful candidate will use engineering judgement, 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.

Education and Experience:

• Bachelor's Degree in Engineering or Scientific field with 4 years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with 3 years of experience -OR- Ph.D. or equivalent in 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.

Preferred Qualifications :

• 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 related to design and data analysis, in particular Python, Minitab, and Excel.
• Strong written and verbal communication skills with the ability to clearly document technical rationale and present findings to cross-functional stakeholders.
• Experience with CAD, engineering specifications, tolerance analysis, and hardware design documentation preferred.
• 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.
• Assign R&D support tasks and train, coach, and guide lower-level employees on routine procedures.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures to prevent injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Key Responsibilities:

• Issue Resolution and Root Cause Investigation: Lead investigations and resolve 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 to minimize device downtime and customer impact.
• Design and Process Improvement: Collaborate with cross-functional teams, including R&D and manufacturing, to identify and lead the implementation of innovative solutions including design changes and process improvements that enhance device reliability, performance, and manufacturability.
• Product Performance Monitoring: Continuously monitor and assess device performance and quality metrics. Develop and execute plans to address deviations from expected performance and support sustained product performance.
• Design Changes & Change Control: Lead design and process changes for on-market medical devices, including design impact assessments, design documentation updates, requirements and specification updates, verification planning, implementation through change control processes, and assessment of potential impacts to labeling and risk.
• Risk Management: Lead risk management activities including updates to design FMEAs, hazard analyses, and risk management files. Evaluate whether identified issues, process changes, or design changes introduce new hazards, impact existing risk controls, or require additional mitigation, verification, or validation.
• Verification and Validation (V&V): Develop, review, and execute engineering 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 and ensure objective evidence supports technical conclusions and design change decisions.
• Documentation and Compliance: Maintain accurate and comprehensive documentation of engineering changes, investigation records, technical reports, test records, risk documentation, and change control documentation. Ensure all activities comply with regulatory requirements and company standards. Collaborate with quality and regulatory to address 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 and ensure effective implementation of engineering solutions.
• Other Duties: Perform other duties as assigned

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