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Engineer II, R&D Sustainment, Hardware, Endotronix

Type

Full time

Location
USA-Illinois -Naperville
Job reference

Req-37856

Posted for

4 days ago

Edwards Lifesciences is growing and our Engineer II, R&D Sustainment, Hardware, Endotronix position is a unique career opportunity that could be your next step towards an exciting future.  This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth. 

For more details on the acquisition, please visit: https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port

How you will make an impact:

This position is ideal for someone with 3-5 years of relevant experience who is passionate about ensuring the highest quality and performance standards for our medical devices. The Sustaining Engineer will play a crucial role in troubleshooting field issues, working closely with manufacturing teams to implement design and process improvements, and maintaining the overall performance and quality of our devices.

  • Troubleshooting: Investigate and resolve device field issues by analyzing product performance data, customer feedback, and failure reports. Provide timely and effective solutions to minimize device downtime and customer impact.

  • Design and Process Improvement: Collaborate with cross-functional teams, including R&D and manufacturing, to identify and implement design changes and process improvements that enhance device reliability, performance, and manufacturability.

  • Device Performance Monitoring: Continuously monitor and assess device performance and quality metrics. Develop and execute plans to address any deviations from established standards and ensure sustained high performance.

  • Documentation and Compliance: Maintain accurate and comprehensive documentation of engineering changes, troubleshooting activities, and quality control measures. Ensure all activities comply with regulatory requirements and company standards. Collaborate with quality and regulatory to address regulatory requests

  • Cross-Functional Collaboration: Work closely with manufacturing, quality assurance, and regulatory teams to support product lifecycle management and ensure seamless integration of engineering solutions.

  • Other duties assigned by Leadership

What you'll need (Required):

  • Bachelor's Degree in Engineering or Scientific field with 2 years experience -OR- Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education

What else we look for (Preferred):

  • Experience in engineering, preferably within the medical device industry.

  • Strong problem-solving skills with the ability to analyze complex technical issues and develop practical solutions.

  • Familiarity with medical device regulations and quality standards (e.g., FDA, ISO) and CAPA process.

  • Proficiency in engineering software and tools related to design and data analysis.

  • Experience with design for manufacturability and product lifecycle management.

  • Knowledge of statistical analysis and quality control methodologies.

  • Hands-on experience with medical device testing and validation.

  • Excellent communication skills, both written and verbal, with the ability to work effectively in a team-oriented environment.

  • Detail-oriented with a strong commitment to documentation and maintaining high quality and performance standards.

  • Good computer skills in usage of MS Office Suite; CAD experience preferred

  • Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

  • Basic understanding of statistical techniques

  • Previous experience working with lab/industrial equipment required (if applicable)

  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

  • Solid problem-solving, organizational, analytical and critical thinking skills

  • Solid understanding of processes and equipment used in assigned work

  • 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 the ability to manage vendors and project stakeholders

  • Ability to build productive internal/external working relationships

  • 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 Illinois (IL), the base pay range for this position is $85,000 to $120,000 (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.   

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Job reference

Req-37856

Jetzt Bewerben
Type

Full time

Location
USA-Illinois -Naperville
Posted for

4 days ago


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About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.


Wichtiger Hinweis für Kandidaten

COVID-Impfvorschrift

Edwards hat sich verpflichtet, die Anforderungen und Richtlinien unserer Regierungsbehörden einzuhalten und unsere gefährdeten Patienten und die Gesundheitsdienstleister, die sie auf der ganzen Welt behandeln, zu schützen. Aus diesem Grund ist für alle Positionen im Gesundheitswesen eine COVID-19-Impfung erforderlich, d. h. für alle, die direkt mit Patienten zu tun haben, und für alle, die im Rahmen ihrer Tätigkeit mit Gesundheitsdienstleistern zu tun haben. Wenn Sie eingestellt werden, müssen Sie als Einstellungsvoraussetzung nachweisen, dass Sie vollständig gegen COVID-19 geimpft sind oder eine gültige religiöse oder medizinische Befreiung von der Impfung haben. Diese Impfpflicht gilt nicht in Ländern, in denen es gesetzlich verboten ist, eine Impfung vorzuschreiben. In Ländern, in denen weniger Impfstoffe zur Verfügung stehen oder andere Anforderungen bestehen, können wir alternative Maßnahmen ergreifen, die die Sicherheit der Patienten und des medizinischen Personals optimieren, z. B. regelmäßige COVID-Tests oder spezielle Maskierungsanforderungen.

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