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Support the lifecycle management of Class III medical devices by investigating field issues and implementing design and process improvements. Ensure continued product safety, reliability, and regulatory compliance through rigorous verification, validation, and risk management activities.
Requires a Bachelor's degree in Engineering or a scientific field with 2 years of experience, or a Master's degree with relevant academic project experience. Preferred candidates have experience with Class III implantable devices, ISO 13485/14971 standards, and proficiency in Python, Minitab, and Excel.
Innovation starts from the heart. At Edwards, 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 Quality, Manufacturing, Regulatory, Clinical, and other cross-functional partners to develop, sustain, and improve 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.
The Engineer II, 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.
In this role you will be responsible for:
Issue Resolution and Root Cause Investigation: Investigate 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 implement 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: Support 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: Support 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
Bachelor's degree in Engineering or scientific field with 2 years of experience
-OR-
Master's degree or equivalent in Engineering or scientific field with industry/education internship, senior project, or thesis
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.
Familiarity with ISO 13485, ISO 14971, FDA quality management system regulations, and applicable medical device regulatory expectations.
Proficiency in engineering software and statistical tools related to design and data analysis, in particular Python, Minitab, and Excel.
Experience developing or executing verification and validation protocols, engineering test methods, and technical reports.
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.
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Global leader in the medical device industry with a patient-focused culture of innovation
Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
There are currently 497 open science & research positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
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