Edwards Lifesciences · 6 hours ago
Process Engineer II
Salt Lake City, UT
Full-time
Onsite
Entry, Mid Level
2+ years expEdwards Lifesciences is committed to making a meaningful difference to patients around the world through innovative medical technologies. The Process Engineer II will optimize manufacturing processes and develop experiments to qualify and validate these processes, ensuring high standards of quality and efficiency in production.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
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; analyzing results, making recommendations, and developing 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; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work
Collaborate across sites and cross functional teams (R&D and commercial)
Coordinate manufacturing builds and raw material allocations
Lead process validations (IQ, OQ, PQ)
Write supporting documentation for the team
Qualification
Required
A Bachelor's degree in Engineering or Scientific field with 2 years of previously related industry experience OR
Master's degree in Engineering or Scientific field
Preferred
Experience working in the medical device industry
Experience working in a manufacturing environment
Knowledge of process development, equipment validation, and/or documentation
Understanding of design requirements documentation, risk management plans, inspection criteria, test method development and validation activities
Good adaptability in changing projects, directions, and priorities
Ability to drive tasks with minimal supervision; self-starter
Good computer skills in usage of MS Office Suite including MS Project
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Strong organization skills with the ability to manage complex projects/tasks
Good time management skills to ensure timely completion of tasks
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
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 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
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Andrew Greene
Vice President, Strategy
Recent News
bloomberglaw.com
2026-01-20
BioWorld Financial Watch
2026-01-15
Orange County Business Journal
2026-01-14
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