Full time
Req-37580
1 day ago
Edwards Lifesciences is growing and our Senior Engineer, Software Testing, Manufacturing, 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:
You will apply your knowledge to develop current processes with the goal of scalability and with a focus in software for manufacturing and test processes.
Key Responsibilities:
Identify, lead and ensure implementation of process development activities to increase throughput and ease of manufacturing to support scalability and capacity. Employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards
Design and develop complex LabVIEW custom software (including writing and executing protocols) or similar for manufacturing and testing purposes; analyze results, make recommendations, and develop reports
Develop and maintain software requirement documentation, maintain software validation plan and protocols. Lead and execute software validation testing for purposes of process validation. Manage manufacturing software within repositories.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of operation and testing software within the manufacturing processes
Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work; work closely with internal and external customers and vendors to resolve issues and provide technical support
Develop and participate in process tracking metrics and use these to drive process improvements (Process capacity tracking, etc.). Interact with vendors and suppliers to ensure timely completion of deliverables.
Other incidental duties
What you'll need (Required):
Bachelor's Degree in Computer Science, Computer Engineering, Electrical Engineering or equivalent
4 years experience developing software requirements, validation, manufacturing, or test software required
What else we look for (Preferred):
Additional Skills:
Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Strong proficiency with LabVIEW and MATLAB and unit testing
Medical device software validation experience ISO13485 – preferable
Medical device manufacturing GMP quality experience – preferable
Experience with Python - preferable
Substantial understanding and knowledge of principles, theories, and concepts relevant to Software Engineering
Strong problem-solving, organizational, analytical and critical thinking skills
Substantial 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 inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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 $90,000 to $127,000 (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 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.
Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable regulation.
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