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USA - California – Irvine, United States of America
Onsite
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 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.
How you will make an impact:
The Engineer II, R&D Sustaining will support lifecycle management of on-market Class III medical devices by investigating field and manufacturing issues, developing automated tools to monitor device performance, 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 working across the boundary between device hardware and data systems, with data-driven investigations, cross-functional collaboration, and ownership of product performance after commercial release. The successful candidate will use engineering judgement, data analysis, algorithm development, design control principles, risk management practices, and verification and validation methods to support product improvements, automated monitoring, and high standards of quality and performance.
In this role you will be responsible for:
Product Performance Monitoring and Data Automation: Continuously monitor and assess device performance and quality metrics using device performance data maintained on a data platform. Develop scripts, dashboards, and automated workflows to identify trends, anomalies, and deviations from expected performance, and support timely decisions regarding device calibration, maintenance, or additional technical assessment.
Algorithm Development and Validation: Develop, implement, and validate analytical algorithms, including machine learning techniques where appropriate, to automate device performance monitoring, support root cause investigations, and generate objective evidence for engineering decisions. Ensure scripts, models, and associated outputs are documented, version controlled, verified, and validated in accordance with applicable quality system expectations.
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. Collaborate with cross-functional teams to review and support CAPA and NCMR documents.
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.
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.
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, medical affairs, sales, suppliers, and other engineering teams to support product lifecycle management and ensure effective implementation of engineering solutions.
Other Duties: Perform other duties as assigned
What you'll need (Required):
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
Proficiency in engineering software, statistical tools, and scripting for data analysis, in particular Python on Databricks or comparable database/data analytics platforms, plus Minitab, and Excel.
Experience developing, validating, and maintaining Python scripts or similar automated data pipelines used for monitoring product performance, detecting anomalies, supporting investigations, or informing maintenance and recalibration decisions.
Familiarity with machine learning, statistical process monitoring, predictive analytics, or anomaly detection methods applied to engineering or device performance data.
Relocation is not provided for this role. Only candidates within a 50-mile radius of Irvine, CA will be considered.
What we look for (Preferred):
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.
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.
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.
COVID Vaccination Requirement
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.