Edwards Lifesciences
Principal Engineer, R&D – Edwards Lifesciences
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.
How you will make an impact
Lead the improvement, design and optimization of complex experiments, testing, analysis of results, and development of reports based on engineering principles that translate to innovative products.
Oversee R&D support tasks; give instruction to technicians and engineers on conducting tests, train them and provide feedback; coordinate work.
Proactively identify issues, achieve resolution, and solve problems of significant complexity on designing parts, components, and subsystems.
Generate work instructions, test methods, engineering models and drawings or prototypes to establish and characterize product and/or process specifications.
Create/update complex design control documents, including requirement specifications and risk documents, with robust knowledge of design control requirements.
Partner with technical engineers on new products in the PDP process, acting as the main interface between R&D, quality, pilot, supplier development, and commercial manufacturing.
Provide relevant inputs and feedback on device design and manufacturability; generate data through DOE, characterization studies, stack‑up analyses, etc., as required.
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerance and defining acceptance criteria.
Independently develop project plans to assess technology and drive project results.
Train, coach, and guide lower‑level employees on complex procedures.
Perform other duties and responsibilities as assigned.
What you’ll need (Required)
Bachelor’s degree in engineering or a scientific field, with a minimum of 6 years of experience (industry or industry/education) or master’s degree or equivalent, with a minimum of 5 years of experience, or Ph.D. or equivalent with a minimum of 2 years of experience. All experience must be industry or industry/education.
Travel 10% domestically or internationally.
What else we look for (Preferred)
Experience in medical device R&D engineering, manufacturing, and process development—especially in heart valve R&D and manufacturing processes.
Understanding of medical device quality system, design control, and regulatory requirements.
Experience in heart valves, stents, tissue, catheters, delivery systems, and/or interventional access devices.
Excellent documentation and communication skills.
Excellent interpersonal and relationship management skills.
Extensive knowledge of engineering principles, theories, and concepts.
Solid understanding of engineering and statistical analysis techniques.
Advanced problem‑solving, organizational, analytical, and critical‑thinking skills.
Extensive understanding of processes and equipment used in assigned work.
Ability to influence others.
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines related to clean‑room medical device manufacturing.
Strict attention to detail.
Professional interaction at all organizational levels.
Ability to manage competing priorities in a fast‑paced environment.
Team‑oriented work with frequent inter‑organizational and customer contacts.
Solution‑oriented representation of the organization on difficult technical issues.
Adherence to all company rules and requirements, including pandemic protocols, Environmental Health & Safety rules, and prevention of injuries and environmental pollution.
For California (CA), the base pay range for this position is $118,000 to $167,000 (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: All patient‑facing and in‑hospital positions require COVID‑19 vaccination. If hired for a covered role, a condition of employment is proof of vaccination unless a medical or religious accommodation is granted. This requirement does not apply in locations where it is prohibited by law to impose vaccination.
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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.
How you will make an impact
Lead the improvement, design and optimization of complex experiments, testing, analysis of results, and development of reports based on engineering principles that translate to innovative products.
Oversee R&D support tasks; give instruction to technicians and engineers on conducting tests, train them and provide feedback; coordinate work.
Proactively identify issues, achieve resolution, and solve problems of significant complexity on designing parts, components, and subsystems.
Generate work instructions, test methods, engineering models and drawings or prototypes to establish and characterize product and/or process specifications.
Create/update complex design control documents, including requirement specifications and risk documents, with robust knowledge of design control requirements.
Partner with technical engineers on new products in the PDP process, acting as the main interface between R&D, quality, pilot, supplier development, and commercial manufacturing.
Provide relevant inputs and feedback on device design and manufacturability; generate data through DOE, characterization studies, stack‑up analyses, etc., as required.
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerance and defining acceptance criteria.
Independently develop project plans to assess technology and drive project results.
Train, coach, and guide lower‑level employees on complex procedures.
Perform other duties and responsibilities as assigned.
What you’ll need (Required)
Bachelor’s degree in engineering or a scientific field, with a minimum of 6 years of experience (industry or industry/education) or master’s degree or equivalent, with a minimum of 5 years of experience, or Ph.D. or equivalent with a minimum of 2 years of experience. All experience must be industry or industry/education.
Travel 10% domestically or internationally.
What else we look for (Preferred)
Experience in medical device R&D engineering, manufacturing, and process development—especially in heart valve R&D and manufacturing processes.
Understanding of medical device quality system, design control, and regulatory requirements.
Experience in heart valves, stents, tissue, catheters, delivery systems, and/or interventional access devices.
Excellent documentation and communication skills.
Excellent interpersonal and relationship management skills.
Extensive knowledge of engineering principles, theories, and concepts.
Solid understanding of engineering and statistical analysis techniques.
Advanced problem‑solving, organizational, analytical, and critical‑thinking skills.
Extensive understanding of processes and equipment used in assigned work.
Ability to influence others.
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines related to clean‑room medical device manufacturing.
Strict attention to detail.
Professional interaction at all organizational levels.
Ability to manage competing priorities in a fast‑paced environment.
Team‑oriented work with frequent inter‑organizational and customer contacts.
Solution‑oriented representation of the organization on difficult technical issues.
Adherence to all company rules and requirements, including pandemic protocols, Environmental Health & Safety rules, and prevention of injuries and environmental pollution.
For California (CA), the base pay range for this position is $118,000 to $167,000 (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: All patient‑facing and in‑hospital positions require COVID‑19 vaccination. If hired for a covered role, a condition of employment is proof of vaccination unless a medical or religious accommodation is granted. This requirement does not apply in locations where it is prohibited by law to impose vaccination.
#J-18808-Ljbffr