Senior R&D Engineer, Valve Testing
Type
Full time
Location
Job reference
Req-37564
Posted for
1 day ago
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
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’ll make an impact
- Develop new test methods and models to evaluate design intent and performance of next generation mitral or tricuspid valves
- 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
- Test class III implantable medical devices in accordance with the specifications, medical guidance, and regulatory safety standards.
- Support and execute implant-testing operations as a member of the valve product development team.
- Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work; train, coach, and guide lower-level employees on routine procedures
- Other duties assigned by Leadership
What you’ll need
A bachelor’s degree in biomedical engineering, mechanical Engineering or related/equivalent engineering/scientific discipline with 4 years of experience required. Advanced degree is a plus
Minimum of 4 years of relevant experience (BS + 4 years or MS + 3 years or PhD + 0 years) with preferable experience with new product development of Class III medical device implants
What else we look for
- Knowledge and experience of relevant FDA guidance and ISO standards such as ISO5840 is highly desired.
- Must be a highly motivated self-starter and able to achieve the quality results with minimal direction.
- Must be proactive and creative in solving technical problems with limited amount of data/information.
- Requires a high-energy individual with excellent team-player attitude and well-developed negotiation skills.
- Excellent verbal and written communication skills, project-management skills, detail orientation and analytical/problem solving skills are a must.
- Proven expertise in usage of MS Office Suite; CAD experience preferred
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Basic understanding of statistical techniques
- Comfortable working in a laboratory environment and with animal tissue, experience with in vitro experimental testing
- 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.
Avviso importante per i candidati
Obbligo di vaccinazione contro il COVID
Edwards si impegna a rispettare i requisiti e le indicazioni delle pubbliche autorità, oltre a proteggere sia i nostri pazienti vulnerabili, sia gli operatori sanitari che se ne prendono cura in tutto il mondo. Proprio per questo richiediamo la vaccinazione contro il COVID-19 per tutte le posizioni che prevedono un’interazione con il sistema sanitario, ovvero per tutte le persone che nello svolgimento della loro mansione si interfacciano direttamente con i pazienti e quelle che interagiscono con gli operatori sanitari. L’assunzione è subordinata alla presentazione di una prova di vaccinazione completa contro il COVID-19 o di un esonero dalla vaccinazione per motivazioni mediche o religiose legittime. L’obbligo di vaccinazione non si applica nei Paesi in cui la legge vieta di imporre la vaccinazione. Nei Paesi con problemi di disponibilità dei vaccini, o che impongono altri requisiti, possiamo adottare misure alternative che ottimizzano la sicurezza dei pazienti e degli operatori sanitari, come test regolari per il COVID o requisiti specifici in materia di mascherine.
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