This is an exciting opportunity to join Edwards Lifesciences Transcatheter Heart Valve (THV) division which focuses on revolutionizing patient care and transforming medicine by innovating breakthrough medical technologies.
Edwards is seeking an experienced and energetic Senior Engineer to support THV R&D delivery system related testing activities, laboratory equipment management and operations.
This is a dynamic, hands-on role. The Senior Engineer will work with all cross-functional teams to support testing needs and testing equipment readiness through early stage characterization, prototyping, test equipment / fixture design, test method development and installation/operational qualification for clinical/commercial product launch.
Job Functions / Responsibilities
- Daily support test laboratory operation, tracking equipment use request, managing training records and ensure smooth scheduling among teams to meet organization growth strategy.
- Identify opportunities for design / re-design of test equipment, tools, fixtures, etc. to improve existing test methods and lab processes.
- Develop, revise and optimize laboratory test methods and standard operating procedures.
- Develop and responsible to implement and complete equipment Lab equipment feasibility study, installation qualification and operational qualification per team needs within assigned timeline;
- Support development team across business units to evaluate effectiveness of test methods, define test strategy, implement test method validation, and/or review product design verification protocol/report.
- Collaborate with cross functional team and create Engineering Change Request to create or revise lab equipment validation documentation, test methods, and fixture drawings.
- Liaise between development teams and R&D Lab in developing test methods and equipment appropriate to comply with Edwards, FDA and ISO standards.
- Employ use of statistical analysis techniques and statistical experimental design, as appropriate.
- Perform calibration and preventive maintenance of laboratory test equipment.
- Demonstrate solid methodical problem-solving skills and use data driven methodologies to execute process characterization and optimization studies
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering or related engineering discipline.
- 4+ years of experience in the medical device or highly regulated industry (automotive, aerospace, pharmaceutical, etc.)
- 3+ years of strong hands-on professional engineering experience required
- Proven expertise in usage of MS Office Suite; CAD experience preferred
- Experience in medical device product or process development; equipment validation and test method validation experience particularly preferred
- Prior work experience in a lab environment with flow, pressure, leak, tensile, visual inspection, and other test instrumentation is highly desirable
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Strong knowledge and understanding of statistical techniques required
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Must be able to effectively articulate, verbally and in writing, results and conclusions to technical and non-technical personnel. Must have strong technical writing skills.
- Strong problem-solving, organizational, analytical and critical thinking skills
- Good leadership skills and ability to influence change
- 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.