Senior Quality Engineer, New Product Transfers
1 month ago
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.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How You Will Make an Impact:
- Oversees and able to prioritize multiple Product Transfers from Pilot and Product development teams
- Build trusted partnerships with key cross functional stakeholders and other Implant sites
- Communicates and drives sustaining initiatives to pilot and product development teams
- Early integration in Design Phase
- Quality Voice of Factory Lead for all product transfers
- Supporting product development teams in verifying clear requirements and specifications are defined and assessing the corresponding Risk Files as part of product transfer
- Support Digital Transformation with SPC, SCADA and MES Integration
- Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
- Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
- Develop, update, and maintain technical content of risk management files Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
- Be a key liaison to Irvine Implant site for knowledge of new products
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Train, coach, and guide lower level employees on routine procedure
- Bachelor's Degree required in an engineering or scientific field, plus (4) years of experience in quality engineering; OR Master's Degree in engineering or scientific field, with (3) years of experience in quality engineering
- Lifesciences industry experience (i.e. medical device, pharma, or biotech)
- Experience with design controls, design verification & validation, or design test method development
- Demonstrated experience reviewing and updating risk management related documents
- Experience utilizing statistical techniques to support design decisions and product acceptance testing
- Master's Degree in an engineering, scientific or a related discipline•
- Medical device industry experience highly preferred.
- Experience in catheter-based therapies preferred.
- Design control and design change experience for product improvements
- Experience with sustaining activities for commercialized products
- Experience in post market investigations, complaint investigations, CAPA investigation, development or manufacturing of transcatheter based therapies
- Strong experience in quality engineering, R&D or manufacturing engineering
- Design for Six Sigma or Lean Six Sigma Certification (Green belt or black belt)
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.
-
Senior Product Design Engineer
3 weeks ago
Irvine, United States altaviz, llc Full timePosition: Sr. Product Development Engineer - MechanicalPosition type: Full-time - OnsiteNo relocation reimbursementDepartment: Drug Delivery ProgramsLocation: Irvine, CAHiring Manager: Director of Drug Delivery ProgramsPosition status: Exempt As a key member of our Drug Delivery Programs team, the successful Senior Product Development Engineer is...
-
Senior Product Design Engineer
3 weeks ago
Irvine, United States altaviz, llc Full timePosition: Sr. Product Development Engineer - MechanicalPosition type: Full-time - OnsiteNo relocation reimbursementDepartment: Drug Delivery ProgramsLocation: Irvine, CAHiring Manager: Director of Drug Delivery ProgramsPosition status: Exempt As a key member of our Drug Delivery Programs team, the successful Senior Product Development Engineer is...
-
Senior Quality Engineer
1 week ago
Irvine, California, United States Balt Full timeAbout Balt Our purpose is to improve the lives of 150,000 patients in 2026. Our story Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices...
-
Senior Quality Engineer
18 hours ago
Irvine, California, United States Balt Full timeAbout Balt Our purpose is to improve the lives of 150,000 patients in 2026. Our story Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices...
-
Senior Quality Engineer
2 days ago
Irvine, United States TalentBurst Full timePosition: Senior Quality Engineer, Req#: 6228-1 Location: Irvine, CA (100% onsite) Duration: 18 Months Contract Job Description: We have an opportunity for a Senior Engineer on the Transcatheter Heart Valve (THV) New Product Development Supplier Quality team. This position will have a primary focus to lead in the development, improvement,...
-
Senior Quality Engineer
3 days ago
Irvine, United States INTELLECTT INC Full timeJob Title: Snr Engineer Location: Irvine, California 92614 Duration: 06+ Months (Possible of extension based on business needs) Job Description Summary: This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of Edwards Global Supply Chain. This cross functional partner will: (1) interact with various...
-
Senior Quality Engineer
4 days ago
Irvine, United States Intellectt Inc Full timeJob Title: Snr EngineerLocation: Irvine, California – 92614Duration: 06+ Months (Possible of extension based on business needs) Job Description Summary: This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of Edwards Global Supply Chain. This cross functional partner will: (1) interact with various...
-
Senior Quality Engineer
21 hours ago
Irvine, United States INTELLECTT INC Full timeJob Title: Snr Engineer Location: Irvine, California 92614 Duration: 06+ Months (Possible of extension based on business needs) Job Description Summary: This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of Edwards Global Supply Chain. This cross functional partner will: (1) interact with various...
-
Senior Supplier Quality Engineer
7 days ago
Irvine, United States Diverse Lynx Full timeob Title Senior Supplier Quality Engineer Relevant Experience (in Yrs) A minimum of Technical/Engineering Degree with 8+ years of related experience Medical Device Supplier Quality domain. Technical/Functional Skills Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive...
-
Senior Supplier Quality Engineer
10 hours ago
Irvine, United States Diverse Lynx Full timeob Title Senior Supplier Quality Engineer Relevant Experience (in Yrs) A minimum of Technical/Engineering Degree with 8+ years of related experience Medical Device Supplier Quality domain. Technical/Functional Skills Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive...
-
Senior Quality Engineer
1 week ago
Irvine, United States Intellectt Inc Full timeRole: Sr. Quality EngineerLocation: Irvine, CA - 92614Duration: 09+ Months Job Duties:The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer has the ability to make engineering drawings, write risk analysis documents and read and interpret...
-
Senior Quality Engineer
1 week ago
Irvine, United States INTELLECTT INC Full timeRole: Sr. Quality Engineer Location: Irvine, CA - 92614 Duration: 09+ Months Job Duties: The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer has the ability to make engineering drawings, write risk analysis documents and read and...
-
Senior Quality Engineer
1 week ago
Irvine, United States Intellectt Inc Full timeRole: Sr. Quality EngineerLocation: Irvine, CA - 92614Duration: 09+ Months Job Duties:The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer has the ability to make engineering drawings, write risk analysis documents and read and interpret...
-
Product Quality Engineer
1 month ago
Irvine, United States Pacer Staffing Full timeJob Title: Product Quality Engineer Location: Irvine, CA Duration: 06+ Months Job Description Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions. Execute complaint investigations multifunctional approach and...
-
Senior Quality Engineer
5 days ago
Irvine, United States JobRialto Full timeJob Description: Summary: The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer has the ability to make engineering drawings, write risk analysis documents and read and interpret drawings. Job Responsibilities: Applies knowledge of...
-
Senior Quality Engineer
4 days ago
Irvine, United States JobRialto Full timeJob Description: Summary: The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical quality engineer has the ability to make engineering drawings, write risk analysis documents and read and interpret drawings. Job Responsibilities: Applies knowledge of...
-
Senior Quality Engineer
2 weeks ago
Irvine, United States Apartment Association of Orange County Full timeTitle: 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 Quality Engineer
6 days ago
Irvine, United States Cynet Systems Full timeJob Description: Pay Range: $54.18hr - $59.18hr Responsibilities: pplies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and client systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Lead identification, development, and...
-
Senior Quality Engineer
1 week ago
Irvine, United States Compunnel Inc. Full timeMust Haves:Test method developmentDevice builds in cleanroomProcess Validation,Risk management.Nice to Have:New product development experienceReceiving inspectionOperator trainingThe opportunity:Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and clients' systems/procedures to optimize product...
-
Senior Quality Engineer
1 week ago
Irvine, United States Compunnel Inc. Full timeMust Haves:Test method developmentDevice builds in cleanroomProcess Validation,Risk management.Nice to Have:New product development experienceReceiving inspectionOperator trainingThe opportunity:Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and clients' systems/procedures to optimize product...