"Alerted.org

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

Follow procedures to manufacture a wireless, handheld Reader unit for pulmonary artery (PA) pressure monitoring. Perform the assembly, tuning, and testing of the Reader and Docking Station devices throughout different stages of manufacturing while following Good Documentation Practices for medical devices. Propose high priority projects to improve system performance and supports team to implement these projects.

Key Responsibilities:

• Use tools and equipment to troubleshoot complex customer returned electrical systems using higher level tools, following prescribed procedures and methods. Uses problem solving skills and technical judgment to determine root causes and corrective actions to resolve customer complaints while applying in-depth knowledge of processes to ensure successful outcomes, as well as to devise, develop, and propose implement process changes. Act as SME - for the full range of legacy electronic systems operations, including data mining documented issues, root cause analysis, and other data bases to establish trends and findings, and develop presentations for collaborative product improvement with engineering.

• Tear-down (reverse engineer) products to determine root cause analysis and document findings in appropriate systems in keeping with regulatory expectations and following EW procedures, as well as preparing and conveying findings to Engineering, and proposing potential solutions/working on team to implement solutions

• Own electrical system performance metrics and data behind those metrics. Communicate metrics, including defect pareto and trends to cross-functional team. Support team to analyze data and implement corrective actions.

• Provide feedback to Engineering on potential opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes

• Identify opportunities for modifications to defect coding, assessing appropriateness of existing codes to assure appropriate follow-on actions, and partner with Engineers to align on product defect determinations

• Execute protocols to develop findings for the validation and improvement of products and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review

• Process units with an understanding of impact on overall results, and independently prioritizes own work schedule

• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period

• Other incidental duties: Other duties as assigned by leadership

What you'll need (Required):

Associate's Degree or equivalent medical device experience preferred Preferred

What else we look for (Preferred):

Additional Skills:

+ Tune and assemble Reader & Dock units and generate proper documentation per manufacturing process instructions.

+ Use tools and equipment to test Printed Circuit Boards and fully assembled Reader & Dock and generate proper documentation per Standard Test Methods and Quality Inspection Protocols.

+ May provide feedback to Engineering on potential opportunities for re-design/design of basic equipment, tools, fixtures, etc to improve manufacturing processes.

+ On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.

+ Other incidental duties: Other duties as assigned by leadership.

+ H.S. Diploma or equivalent in or equivalent, 5 years previous related experience in high reliability field, required

+ Associate's Degree or equivalent Previous medical device experience, preferred.

+ Basic computer skills required, including experience with MS Office Suite

+ Ability to read, comprehend, write and speak English, and good communication skills required

+ Adhere to Edwards, Environmental Health and Safety, Electro Static Discharge, and Quality guidelines as they relate to medical device manufacturing

+ Must be able to work with minimum supervision by following detailed manufacturing instructions

+ Work in a Team environment primarily with immediate work group

+ Flexibility to work overtime to ensure smooth and continuous manufacturing processes

+ Ability to adhere to project schedules and managing small projects

+ Problem solving methodology, root cause analysis, Quality System Fundamentals, and good documentation practices, preferred

+ Moderate understanding of evaluating electrical system field returns

+ Ability to use specialized tooling, hand eye coordination, and high manual dexterity

+ Successful completion of ongoing job training of electronic assembly processes

+ Overall understanding of soldering in high reliability equipment

+ Strict attention to detail

+ Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures

+ 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 $60,000 to $84,000 (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 Requirement

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.