Engineer II, R&D Sustainment

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. Its 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 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

What youll need (Required):

• Bachelors degree in Engineering or scientific field with 2 years of experience -OR-Masters degree or equivalent in Engineering or scientific field with industry/education internship senior project or thesis

• 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.

• 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 $87000 to $123000 (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.