Sr Engineer, Manufacturing

Edwards Lifesciences; Naperville (IL); On-site; USD 106,000 - 149,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Sr Engineer, Manufacturing to enhance their Implantable Heart Failure Management team. This role involves leading engineering efforts for electronics assembly, improving processes, and ensuring compliance with regulatory standards. The ideal candidate will have a Bachelor's degree in engineering and significant experience in a regulated manufacturing environment, particularly with electronic devices.

Benefits

Competitive salaries

Performance-based incentives

Variety of benefits programs

Qualifications

• Minimum 5 years in a manufacturing environment preferred.
• Experience in regulated industry is a plus.
• Strong background in mechanical, electrical or software design.

Responsibilities

• Lead and support process development activities.
• Perform and support Design Transfer activities.
• Author and maintain risk documentation for manufacturing processes.

Skills

Root cause analysis

Statistical data analysis

Technical writing

Process improvements

Collaboration

Education

Bachelor's Degree in Engineering

Tools

SolidWorks

Minitab

LabVIEW

MATLAB

Microsoft Office Suite

Job description

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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.

Help lead the IHFM Manufacturing Engineering team for electronics assembly of the Cordella Patient Reader. Work with PCB assembly and fab house vendors to improve yield and implement design-for-manufacture improvements. Troubleshoot high-priority field and production issues and resolve corrective actions. Define and develop automated and semi-automated systems & processes to improve reliability, accuracy and throughput of product. Provide effective and compliant documentation of all aspects of the role to meet internal and external quality/Regulatory requirements. Work in collaboration with R&D, Quality, and Manufacturing to support efforts as directed. Become a key SME for Manufacturing related to products with electrical/electronic functions. Manage others when assigned, ensuring goals and objectives are met.

How you will make an impact:

• Take ownership of processes and become the SME related to Class-III medical device product and process.
• Lead and support process development activities to account for design changes, performance, and yield improvements and/ mitigations to the product.
• Seek out state-of-the-art and automation tools for incorporation into Class-III medical device production processes.
• Lead and support in-house manufacturing of product through the development, authoring, review, and execution of production documentation (manufacturing process instructions, inspections, specification/ drawings, routers, etc.).
• Lead and/ or participate in root cause investigations, CAPA/NCR corrective actions, and other investigation activities.
• Independently gather, organize, and analyze data.
• Author and maintain risk documentation (PMEA, etc.) for the manufacturing process and product.
• Perform and support Design Transfer activities to manufacturing, including all aspects of Process Validation.
• Develop and participate in process tracking metrics and use these to drive process improvements (Scrap/ Yield Tracking, Cost Tracking, etc.)
• Write and Execute Process Validation of Equipment and Manufacturing Processes in the forms of IQ/ OQ/ PQ.
• Design, develop and fabricate test fixtures for the purposes of process improvements.
• Perform Test Method Validation of inspections including Gage R&R analysis.
• Interact with vendors and supplies to ensure quality product.
• Work in a strong collaborative effort with R&D, Quality, and Manufacturing.
• Perform additional related actions and duties as outlined and requested by management
  
  

What you'll need (Required):

Bachelor's Degree in in related field related experience in engineering Required and

Experience Working In a Regulated Industry Preferred

What else we look for (Preferred):

• Prefer at least 5 years in a manufacturing environment involving electronic and/or software process improvements, preferably within a regulated industry
• Working knowledge of ISO and FDA guidelines and requirements.
• Demonstrated competency of Quality systems and processes.
• Demonstrated ability to bring projects from feasibility through implementation.
• Root cause analysis experience.
• Demonstrated ability to work independently with minimal supervision.
• Excellent oral and written communication skills, particularly in technical writing and documentation.
• Demonstrated organizational, interpersonal, and critical thinking skills.
• Strong background in mechanical, electrical or software design.
• Experience with statistical data analysis.
• Experience with SolidWorks, Minitab, LabVIEW, and/or MATLAB preferred.
• Proficiency with Microsoft Office Suite.
• Risk analysis experience (PFMEA, DFMEA, etc.)
  
  

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 $106,000 to $149,000 (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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Equipment Manufacturing

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