Senior Systems Engineer, R&D

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. 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:

As a Systems Engineer this individual will be a member of the Research & Development team responsible for new product design and development risk management and product performance improvements for the hardware components of the Cordella platform. This is a collaborative position in which the Systems Engineer will work closely with other hardware and software engineers quality regulatory manufacturing and other individuals throughout the company.

• Lead development and execution of engineering project plans including designing and conducting complex experiments (including writing and executing protocols) analyzing results and delivering reports based on engineering principles

• Generate work instructions test methods engineering models and drawings/prototypes etc. to establish/characterize product and/or process specifications

• Create/update more complex design control documents including requirement specs and risk documents (Hazard Analysis Design FMEAs and Use FMEAs)

• Lead design change impact assessments ensuring risks requirements and validations are appropriately addressed

• Ensure compliance with applicable standards and regulatory requirements throughout the product lifecycle

• Conduct user research and usability evaluations to support safe effective design decisions

• Maintain a complete organized Design History File (DHF) to support traceability and audit readiness

• Drive system-level strategies and solutions to effectively navigate design and development processes ensuring alignment with technical regulatory and business objectives

• Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

• Evaluate input and form a technical recommendation including designing parts components and subsystems

• Train coach and guide lower-level employees on routine procedures

• Other duties assigned

What youll need (Required):

• Bachelors Degree in Engineering or Scientific field with 4 years of experience -OR- Masters 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 medical devices and FDA quality practices and standards including ISO 13485

• Prior experience performing testing to support V&V and risk management activities

• Prior experience working within Design Controls and DHF ownership

• Relocation is not provided for this candidates within a 50-mile radius of Irvine CA will be considered.

What else we look for (Preferred):

• Experience in medical devices with both hardware and data and/or software is preferred

• Experience with FDA submissions for product approvals

• Prior experience processing parsing and analyzing data including script development for automation and statistical analysis methods using Excel and Minitab

• Demonstrated ability to work independently with minimal supervision

• Strong written and verbal communication skills with the ability to clearly document technical rationale and present findings to cross-functional stakeholders.

• Demonstrated organizational interpersonal and critical thinking skills

• Strict attention to detail and commitment to high quality documentation

• Ability to interact professionally with all organizational levels

• 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 $108000 to $153000 (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.