Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and delivering lasting solutions for unmet patient needs. Our Senior Manufacturing Engineer position offers a unique career opportunity to contribute to highly visible products and advance manufacturing excellence.
Imagine how your ideas and expertise can change a patient's life. Our Manufacturing Engineering - Pilot team plays a critical role in enabling robust, scalable manufacturing processes prior to full commercialization. In this role, you will partner cross-functionally with Manufacturing, Quality, R&D, and Operations teams to support pilot production, qualify processes and equipment, and drive continuous improvement within a regulated medical device environment.
How you'll make an impact:
Apply knowledge of technical engineering principles and Edwards systems and procedures to support, optimize, and sustain manufacturing processes within a pilot production environment.
Identify, recommend, and help implement opportunities to improve manufacturing processes using engineering methods such as Lean and Six Sigma; apply technical design skills to design, redesign, qualify, and ensure equipment, tools, and fixtures meet applicable standards and requirements.
Develop and execute complex experiments and testing activities, including authoring and executing protocols, to qualify and validate manufacturing processes; analyze results, provide recommendations, and document findings in formal reports.
Analyze and resolve complex manufacturing and compliance issues, including CAPA, non-conformances, and audit observations, ensuring timely and effective resolution.
Develop and maintain training materials and manufacturing documentation (e.g., work instructions and procedures) to enable effective knowledge transfer and consistent execution of pilot and manufacturing processes.
Lead and manage project plans to ensure deliverables are completed on time and meet customer expectations, utilizing project management tools such as project plans, schedules, and risk analyses.
Provide hands-on manufacturing support by overseeing technician activities; instructing and training technicians on test execution and process tasks; providing feedback; and coordinating day-to-day technician work.
Perform other duties as assigned by leadership to support pilot operations and business needs.
What you'll need (Required):
Bachelor's Degree in Engineering or a related scientific field; 4 years of relevant experience; OR
Master's Degree or equivalent in Engineering or a related scientific field; 3 years of relevant experience; OR
Ph.D. or equivalent in Engineering or a related scientific field with relevant industry and/or academic experience.
What else we look for (Preferred):
Demonstrated proficiency with the MS Office Suite, including MS Project; CAD experience preferred, where applicable.
Strong documentation, written and verbal communication, and interpersonal skills, with the ability to build effective consultative relationships with cross-functional partners.
Working knowledge of basic statistical techniques and their application in manufacturing and process validation environments.
Previous hands-on experience working with lab and/or industrial manufacturing equipment, as applicable.
Solid understanding of engineering principles, theories, and concepts relevant to manufacturing and pilot operations.
Strong problem-solving, organizational, analytical, and critical-thinking skills, with the ability to evaluate and resolve complex issues.
Thorough understanding of manufacturing processes and production equipment used within the assigned area.
Demonstrated leadership capabilities, with the ability to influence change and drive continuous improvement initiatives.
Knowledge of and compliance with Edwards Environmental Health & Safety (EHS) and Quality System requirements, particularly within clean-room medical device manufacturing environments.
Working knowledge of applicable FDA regulations and regulatory expectations for the medical device industry.
High attention to detail with a strong commitment to accuracy and quality.
Ability to interact professionally and effectively with employees at all organizational levels, including senior internal and external stakeholders.
Proven ability to manage multiple competing priorities in a fast-paced, dynamic environment.
Ability to work collaboratively in a team-based, cross-functional environment and represent the organization on projects or external engagements as needed.
Commitment to adhering to all company policies and requirements, including Environmental Health & Safety regulations, injury-prevention practices, and environmental protection and pollution-prevention measures within one's area of responsibility.
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 $108,000 to $153,000 (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.
