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-portHow 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.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.