Principal Engineer, Manufacturing

Principal Engineer, Manufacturing

02 Mar 2024
California, Irvine, 92602 Irvine USA

Principal Engineer, Manufacturing

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.How you will make an impact:

Leading in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards.

Driving the development and manage the execution of complex experiments and tests (including writing and executing protocols) on a simple product line to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.

Training, coaching, and guiding lower-level employees on more complex procedures

Overseeing manufacturing support tasks; giving instruction to engineers/ technicians on conducting tests; training engineers/ technicians and providing feedback; and coordinating engineer/ technician work.

Leading and establishing complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).

Analyzing and resolving complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).

Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.

What you’ll need (Required):

Bachelor's Degree in Engineering or Scientific field with a minimum of 6 years of industry related experience OR Master’s Degree in Engineering or Scientific field with a minimum of 5 years of industry related experience Required

What else we look for (Preferred):

Six Sigma Black Belt certified

Solidworks and Fixture development

Catheter process development (ie Reflow, RF)

Proven expertise in usage of MS Office Suite; CAD experience preferred

Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills

Ability to translate technical information to all levels of the organizations

Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering

Advanced problem-solving, organizational, analytical and critical thinking skills

Extensive understanding of processes and equipment used in assigned work

Strong leadership skills and ability to influence change

Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts

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, the base pay range for this position is $115,000 to $163,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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