Edwards Lifesciences Corp

Engineer II, Digital Manufacturing Execution Systems

Edwards Lifesciences Corp • $75K — $95K *
Salt Lake City, UT 84118In-Person
Manufacturing & Automotive
Less than 5 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Engineering or related scientific field with 2 years experience.
  • Master's Degree with internship or thesis experience in Engineering or related field.
  • Understanding of engineering principles and concepts, especially in the medical device industry.
  • Proficiency in MS Office, including MS Project; CAD expertise is a plus.
  • Familiarity with FDA regulations and compliance requirements for medical devices.

Responsibilities

  • Optimize manufacturing processes using Six Sigma and LEAN methods.
  • Develop and execute experiments to validate manufacturing processes and analyze results.
  • Analyze and resolve manufacturing and compliance issues like CAPA and audit findings.
  • Create training materials and documentation for knowledge transfer in production environments.
  • Establish project plans to ensure timely delivery of project goals and customer expectations.
  • Oversee manufacturing support tasks and provide training and feedback to technicians.
  • Perform additional tasks as assigned by leadership.

Benefits

  • Opportunity for professional growth in the medical device industry.
  • Access to continuous improvement methodologies like Six Sigma and LEAN.
  • Involvement in diverse and impactful projects within the manufacturing sector.
  • Supportive team environment with opportunities for collaboration and skill enhancement.
Full Job Description
This Engineer II will support the Draper site's digital functionality with their primary focus on the Manufacturing Execution System or MES. This individual will support the day-to-day operations of all commercial lines within the site, new product rollouts, and enhancements or improvements to the existing models.

How you'll make an impact:
  • Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills
  • Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
  • Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
  • Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
  • Establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
  • Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
  • Other incidental 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 with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education


What else we look for (Preferred):
  • Medical device industry experience
  • Good computer skills in usage of MS Office Suite including MS Project; CAD experience
  • Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
  • Basic understanding of statistical techniques
  • 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
  • Knowledge of applicable FDA regulations for medical device industry
  • 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
  • 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

About Edwards Lifesciences Corp

Edwards Lifesciences is an American medical technology company headquartered in Irvine, California, specializing in artificial heart valves and hemodynamic monitoring. It developed the SAPIEN transcatheter aortic heart valve made of cow tissue within a balloon-expandable, cobalt-chromium frame, deployed via catheter. The company has manufacturing facilities at the Irvine headquarters, as well as in Draper, Utah; Costa Rica; the Dominican Republic; Puerto Rico; and Singapore; and is building a new facility due to be completed in 2021 in Limerick, Ireland.
Learn more about Edwards Lifesciences Corp
Size
15,700 employees
Market Cap
$45.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$823.4 million
Founded
1958
5 Year Trend
+12%
Revenue
$4.3 billion
NASDAQ
EW
* Ladders Estimates

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