Senior Engineer, R&D

2 weeks ago

Irvine, United States Edwards Lifesciences Full time

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

At Edwards, innovation starts from the heart, and patients come first We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. As a Senior Engineer in our THV R&D team, you'll work closely with Quality and Manufacturing to develop cutting-edge tools and technologies that address unmet clinical needs and improve patients' lives globally. Your primary focus will be developing the distal end of next-gen TAVR delivery systems, leveraging your strong problem-solving abilities, collaborative skills, and design and development expertise to work effectively with cross-functional and cross-site partners.

How you'll make an impact:

  • Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop 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
  • Develop and execute engineering project plans
  • Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
  • 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 by Leadership
What you'll need (Required):
  • Bachelor's degree in Engineering field and 4+ years' experience in medical device - OR
  • Master's degree in Engineering and 3+ years' experience in medical device - OR
  • Strong communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
  • Working understanding of statistical techniques
  • Strong problem-solving, organizational, analytical and critical thinking skills
  • Experience integrating multiple devices or processes and understanding how they work as a single system
What else we look for (Preferred):
  • Proven expertise in usage of MS Office Suite; CAD experience preferred
  • Previous experience working with lab/industrial equipment required (if applicable)
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Substantial understanding of processes and equipment used in assigned work
  • Good 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 inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
  • 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, the base pay range for this position is $103,000 to $146,000 (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 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.

  • R&D Engineer

    3 weeks ago

    Irvine, United States Diverse Lynx Full time

    Job Title: R&D Engineer Location: Irvine C Onsite Duration: Fulltime Job Description : Job Title R&D Engineer Relevant Experience (in Yrs) 3+ years of work experience in the Medical Device industry in R&D field 6+ years of experience for bachelor's degree in Mechanical or Biomedical Engineering or, 5+ years of experience for master's degree in Mechanical...

  • R&D Engineer

    3 days ago

    Irvine, United States Motion Recruitment Full time

    Our client is seeking a motivated R&D Engineer.Essential Job Functions:Test, and/or improve products by developing moderately complex experiments and tests (Including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles 25%Generate work instructions, test methods, engineering...

  • R&D Engineer

    5 days ago

    Irvine, United States Motion Recruitment Full time

    Our client is seeking a motivated R&D Engineer.Essential Job Functions:Test, and/or improve products by developing moderately complex experiments and tests (Including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles 25%Generate work instructions, test methods, engineering...

  • Senior R&D Chemist

    2 weeks ago

    Irvine, United States Kelly Services, Inc. Full time

    #x 9; Understand and run HPLC, GC, ICP, UV, FTIR, Dissolution tester and other analytical instrumentation in an analytical lab set up. Work on MS Word, Excel, and any one of the chromatography data collection and management software such as Empower, R&D, Chemist, Senior, Chemistry, Analytical, Staffing, Pharmaceutical, Technology

  • Engineer II R&D

    4 weeks ago

    Irvine, United States Planet Pharma Full time

    R&D Engineer II-Prior experience as a sustaining engineer (R&D) in a medically regulated industry (Class II or III highly preferred)-Design verification and validation experience in the medical device industry-Basic understanding of Solidworks CAD system-Exposure to failure mode analysis.-PPK, MLTL, or any base level knowledge of statistical tools or...

  • Engineer II R&D

    3 weeks ago

    Irvine, United States Planet Pharma Full time

    R&D Engineer II -Prior experience as a sustaining engineer (R&D) in a medically regulated industry (Class II or III highly preferred) -Design verification and validation experience in the medical device industry -Basic understanding of Solidworks CAD system -Exposure to failure mode analysis. -PPK, MLTL, or any base level knowledge of statistical tools or...

  • Engineer II R&D

    4 weeks ago

    Irvine, United States Planet Pharma Full time

    R&D Engineer II-Prior experience as a sustaining engineer (R&D) in a medically regulated industry (Class II or III highly preferred)-Design verification and validation experience in the medical device industry-Basic understanding of Solidworks CAD system-Exposure to failure mode analysis.-PPK, MLTL, or any base level knowledge of statistical tools or...

  • Senior Engineer, R&D

    1 week ago

    Irvine, United States Edwards Full time

    Edwards Lifesciences Careers **Senior Engineer, R&D - Delivery Systems** * **type** Full time * **Location** USA, California, Irvine * **Job reference** Req-14066 * **Posted for** 16 Days **Were looking for engineers with *HEART*.** At Edwards Transcatheter Mitral and Tricuspid Therapies (TMTT), we are guided by our vision to lead and transform treatment...

  • Senior R&D Chemist

    2 weeks ago

    Irvine, United States LGM PHARMA SOLUTIONS LLC Full time

    We currently have an opening for a Senior R&D Chemist in our Research and Development team based in the Irvine, CA location. Responsibilities: * Conduct method improvement and modifications on commercial analytical methods for pharmaceuticals. * Conduct method development and USP methods feasibility studies for essay, trace elements, and associated...

  • Senior R&D Chemist

    3 weeks ago

    Irvine, United States LGM PHARMA SOLUTIONS LLC Full time

    Job DescriptionJob DescriptionWe currently have an opening for a Senior R&D Chemist in our Research and Development team based in the Irvine, CA location. Responsibilities:Conduct method improvement and modifications on commercial analytical methods for pharmaceuticals. Conduct method development and USP methods feasibility studies for essay, trace elements,...

  • R & D Intern - Mechanical Engineering (Medical Device)

    4 weeks ago

    Irvine, California, United States Johnson & Johnson Full time

    J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops.Johnson & Johnson Surgical Vision...

  • Senior Quality Engineer

    3 days ago

    Irvine, United States ShiftCode Analytics Full time

    Title: Senior Quality Engineer (Design) Location: Irvine, CA On-site Duration: 6 months+ Visa: Any Visas(except h1b and CPT) Interview: Phone/Zoom Key Role Responsibilities: •Focus on activities supporting design control, design verification/validation, FMEA/risk management, specification development, statistical reliability, critical to quality/process...

  • Senior Supplier Quality Engineer

    5 days ago

    Irvine, United States Diverse Lynx Full time

    Title: Senior Supplier Quality Engineer Location: : Irvine, CA - Onsite Full time/ Permanent 1. Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971. 1. Provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or...

  • Senior Engineer, Supplier Quality

    3 days ago

    Irvine, United States Edwards Lifesciences Full time

    Edwards Lifesciences has an opportunity for a Senior Engineer, Supplier Quality on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team. This cross-functional position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals...

  • Senior Homologation Engineer

    2 weeks ago

    Irvine, United States Kett Engineering Full time

    Job DescriptionJob DescriptionKett Engineering is looking for a Senior Fuel Economy Certification Engineer to help our Automotive Customer and their reliability team in Irvine!This will be a mostly remote position with some potential onsite work in IrvineAs a Senior Homologation Engineer this role will take responsibility for all interactions necessary to...

  • Senior Quality Engineer

    1 week ago

    Irvine, United States Motion Recruitment Full time

    Title: Senior Engineer (Quality) Location: Irvine, CA Duration: Contract About the Client: Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitoring. With a rich heritage built upon values of integrity, collaboration, and...

  • Senior Quality Engineer

    2 weeks ago

    Irvine, United States Motion Recruitment Full time

    Title: Senior Engineer (Quality)Location: Irvine, CADuration: Contract About the Client:Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitoring. With a rich heritage built upon values of integrity, collaboration, and relentless...

  • Senior Quality Engineer

    2 weeks ago

    Irvine, United States Motion Recruitment Full time

    Title: Senior Engineer (Quality)Location: Irvine, CADuration: Contract About the Client:Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitoring. With a rich heritage built upon values of integrity, collaboration, and relentless...

  • Senior Material Compliance Engineer

    2 weeks ago

    Irvine, United States Kett Engineering Full time

    Job DescriptionJob DescriptionKett Engineering is looking for a Senior Material Compliance Engineer to help our Automotive Customer in Irvine!This will be a mostly remote position with some potential onsite work in IrvineDuties include:Ensure products meet global substance of concern and recyclability regulations, such as: California Prop 65; Registration,...

  • EMC Engineer

    3 days ago

    Irvine, United States Broadcom Corporation Full time

    Full time EMC engineer in Irvine CA. Requires active involvement in EMC testing for various products. Requires interaction with design engineers for testing and debugging. Responsible for cooperation with EMC R&D engineers. Responsible for internal and external customer EMC reports. Knowledgable of EMC standards. Knowledgable of Electromagnetics. Hands-on...