Engineer II, R&D Sustainment

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue toward 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 that address significant, unmet clinical needs.

• 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.
• Collaborate with R&D and manufacturing to identify and implement design changes and process improvements that enhance device reliability, performance, and manufacturability.
• Continuously monitor and assess device performance and quality metrics; develop and execute plans to address deviations from expected performance and support sustained product performance.
• Support design and process changes for on‑market medical devices, including design impact assessments, documentation updates, verification planning, implementation through change control processes, and assessment of potential impacts to labeling and risk.
• 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.
• 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.
• Maintain accurate and comprehensive documentation of engineering changes, investigation records, technical reports, test records, risk documentation, and change control documentation, ensuring compliance with regulatory requirements and company standards.
• 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.

• Bachelor’s degree in Engineering or a scientific field with 2 years of experience, -OR- Master’s degree or equivalent in Engineering or a scientific field with industry/education internship, senior project, or thesis.

• Experience supporting on‑market medical devices, preferably ClassIII 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, particularly 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.

For California (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced). 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.

All patient‑facing and in‑hospital positions require COVID‑19 vaccination. 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.

Edwards is an Equal Opportunity/Affirmative Action employer, including protected Veterans and individuals with disabilities.