This position offers a hybrid schedule, blending the convenience for onsite collaboration and remote work.
Imagine how your ideas and expertise can change a patient’s life. Our Global Supply Chain team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
The Engineer II will play a key role in supporting the Transcatheter Mitral and Tricuspid Therapies portfolio by systematically monitoring devices post-commercialization. This ensures that products remain safe and effective after regulatory approval. The role involves analyzing performance data, identifying trends, and driving continuous improvements to uphold patient safety and product reliability.
How you’ll make an impact:
Participate in, and own escalation tasks and activities including Product Risk Assessment (PRAs) and Corrective/Preventive action(s) (CAPAs) as appropriate based on issue investigation.
Identify and own improvement projects associated with the optimization of internal processes through the utilization of engineering methods (e.g. Six Sigma and LEAN).
Identify and report key complaint metrics per device category and collaborate with applicable manufacturing/R&D teams to investigate and resolve device related issues. Update and maintain technical content of risk management files.
Train, coach, and guide lower-level employees on routine procedures.
Perform other duties and responsibilities as assigned.
What you’ll need:
Bachelor’s degree in Engineering or a Scientific, with a minimum of 2 years of experience in engineering and/or compliance within the medical device or pharmaceutical industry.
Proven hands-on experience managing processes and workflows in highly regulated environments, ensuring adherence to strict compliance and quality standards.
What else we look for:
Advanced degree in a relevant field.
Experience within the medical device industry, with a strong understanding of industry standards and practices.
Knowledge of applicable MDR and FDA regulations governing the medical device industry.
Knowledge of risk management principles and practices.
Proficiency in MS Office Suite and other relevant software tools.
Exceptional documentation and communication skills (written and verbal), with strong interpersonal and consultative abilities.
Strong problem-solving, organizational, analytical, and critical thinking skills.
Ability to interact professionally and effectively across all organizational levels.
Proven ability to manage competing priorities in a fast-paced environment.
Collaborative team player with experience managing project stakeholders and driving results.
For California (CA), the base pay range for this position is $85,000 to $120,000 (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.