Sr. Process Engineer

Salt Lake, UT - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

Position Summary:

The Senior Process Engineer to champion daily manufacturing performance and long-term operational improvements. This role is deeply embedded on the production floordriving process capability refining tooling and process concepts mentoring technical staff and enabling cost-effective high-quality production. You will oversee technical projects from early definition through implementation always with an emphasis on practical improvements that stabilize simplify and enhance manufacturing operations.

PRIMARY RESPONSIBILITIES:

Promote a safety first mentality for all production areas equipment processes and procedures.
Provide guidance and daytoday direction to technicians and engineers on assigned activities and best practices.
Utilize lean process technology and automation during manufacturing execution to continuously improve the manufacturing environments driving cost leadership world-class quality and customer satisfaction.
Collaborate with new product introduction teams to ensure seamless implementation of new process flows and assist with transfer activities.
Complete projects report status and document lessons learned efficiently; utilize project management tools to establish timelines action item lists assignments due dates and milestones.
Lead process validation activities including IQ OQ and PQ for equipment tooling and processes.
Develop/improve processes and sampling activities as well as tooling and manufacturing concepts that meet customer expectations on cost quality and delivery.
Lead process improvement and waste elimination efforts through the application of lean principles; actively participate in continuous improvement events.
Conducts DOE studies process characterization and root-cause analysis to establish and maintain robust process windows.
May communicate with existing customers on changes to existing processes conveying timelines and managing validation activities related to the change.
Apply statistical tools to establish/monitor capability and verify effectiveness of improvements.
Lead investigations and drive NCR/MRB/CAPA actions to closure in partnership with Quality and Operations; execute approved changes via change control.
Demonstrates all corporate values

- We think and act like owners.
- We are bold in our aspirations while moving forward with humility and integrity.
- We are committed to making our customers successful.
- We foster inspired teams

Minimum Qualifications:

Bachelor of science in a related engineering field from a four-year college or university.
5 years of engineering experience within a medical device or contract medical device manufacturing environment.
Working knowledge of typical medical device manufacturing techniques (tipping thermoplastic injection molding and extrusion).
Proficiency in Microsoft Word Excel PowerPoint and Minitab (or other statistical analysis software).
Proven experience leading IQ/OQ/PQ and working to ISO 13485 / FDA 21 CFR 820.
Practical experience using DOE SPC and Gage R&R familiarity with control plans and PFMEA.
Must have advanced skills in Microsoft Word Excel PowerPoint and Minitab (or other statistical analysis software). SOLIDWORKS or CAD modeling software is a plus
Analytical and problemsolving skills; detailoriented and able to produce accurate professional documentation.
Motivated and creative; operates effectively under pressure in a fastpaced team environment.
Excellent interpersonal skills with the ability to communicate needs and demands effectively.
Drives continuous improvement and waste elimination through lean principles.

Physical Demands:

The employee may be required to lift and/or move up to 25 pounds
The employee may be required to sit for extensive periods.

Work Environment:

The job is performed indoors in a variety of settings including the office manufacturing floor and warehouse. Exposure to loud noises dust and dirt may occur. Protective safety clothing/gear may be required. Activities include extended periods of standing or sitting and extensive work with measuring devices and other machinery.

Required Experience:

Senior IC

Position Summary:The Senior Process Engineer to champion daily manufacturing performance and long-term operational improvements. This role is deeply embedded on the production floordriving process capability refining tooling and process concepts mentoring technical staff and enabling cost-effective ...

Position Summary:

PRIMARY RESPONSIBILITIES:

Promote a safety first mentality for all production areas equipment processes and procedures.
Provide guidance and daytoday direction to technicians and engineers on assigned activities and best practices.
Utilize lean process technology and automation during manufacturing execution to continuously improve the manufacturing environments driving cost leadership world-class quality and customer satisfaction.
Collaborate with new product introduction teams to ensure seamless implementation of new process flows and assist with transfer activities.
Complete projects report status and document lessons learned efficiently; utilize project management tools to establish timelines action item lists assignments due dates and milestones.
Lead process validation activities including IQ OQ and PQ for equipment tooling and processes.
Develop/improve processes and sampling activities as well as tooling and manufacturing concepts that meet customer expectations on cost quality and delivery.
Lead process improvement and waste elimination efforts through the application of lean principles; actively participate in continuous improvement events.
Conducts DOE studies process characterization and root-cause analysis to establish and maintain robust process windows.
May communicate with existing customers on changes to existing processes conveying timelines and managing validation activities related to the change.
Apply statistical tools to establish/monitor capability and verify effectiveness of improvements.
Lead investigations and drive NCR/MRB/CAPA actions to closure in partnership with Quality and Operations; execute approved changes via change control.
Demonstrates all corporate values

- We think and act like owners.
- We are bold in our aspirations while moving forward with humility and integrity.
- We are committed to making our customers successful.
- We foster inspired teams

Minimum Qualifications:

Bachelor of science in a related engineering field from a four-year college or university.
5 years of engineering experience within a medical device or contract medical device manufacturing environment.
Working knowledge of typical medical device manufacturing techniques (tipping thermoplastic injection molding and extrusion).
Proficiency in Microsoft Word Excel PowerPoint and Minitab (or other statistical analysis software).
Proven experience leading IQ/OQ/PQ and working to ISO 13485 / FDA 21 CFR 820.
Practical experience using DOE SPC and Gage R&R familiarity with control plans and PFMEA.
Must have advanced skills in Microsoft Word Excel PowerPoint and Minitab (or other statistical analysis software). SOLIDWORKS or CAD modeling software is a plus
Analytical and problemsolving skills; detailoriented and able to produce accurate professional documentation.
Motivated and creative; operates effectively under pressure in a fastpaced team environment.
Excellent interpersonal skills with the ability to communicate needs and demands effectively.
Drives continuous improvement and waste elimination through lean principles.

Physical Demands:

The employee may be required to lift and/or move up to 25 pounds
The employee may be required to sit for extensive periods.

Work Environment:

The job is performed indoors in a variety of settings including the office manufacturing floor and warehouse. Exposure to loud noises dust and dirt may occur. Protective safety clothing/gear may be required. Activities include extended periods of standing or sitting and extensive work with measuring devices and other machinery.

Required Experience:

Senior IC

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

Irco

Driven by an entrepreneurial spirit and ownership mindset, committed to helping make life better. We provide innovative and mission-critical industrial, energy, medical and specialty vehicle products and services across 40+ respected brands designed to excel in even the most complex a ... View more

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