Process Engineer II

Salt Lake, UT - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world our Manufacturing teams create the tools technologies and devices that transform patients lives. As part of our sewing assembly delivery and distribution teams your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

Aortic stenosis impacts millions of people globally yet it often remains under-diagnosed and under-treated. Edwards groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. Its 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:

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 customers 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.

What youll need (Required):

A Bachelors degree in Engineering or Scientific field with 2 years of previously related industry experience OR
Masters degree in Engineering or Scientific field

What else we look for (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

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.

Required Experience:

How you will 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; 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 customers 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.

What youll need (Required):

A Bachelors degree in Engineering or Scientific field with 2 years of previously related industry experience OR
Masters degree in Engineering or Scientific field

What else we look for (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

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Required Experience:

Key Skills

Lean Manufacturing
Six Sigma
Distributed Control Systems
Continuous Improvement
Process Improvement
Minitab
Root cause Analysis
Process Engineering
cGMP
Kaizen
Programmable Logic Controllers
Manufacturing

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About Company

Edwards Lifesciences

Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more

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