Trevor, WI · On-site
$70K - $85K/yr
Preferred Qualifications Experience in flexible films, medical packaging, or converting operations. Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing ...
Trevor, WI · On-site
$70K - $85K/yr
Preferred Qualifications Experience in flexible films, medical packaging, or converting operations. Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing ...
Trevor, WI · On-site
$70K - $85K/yr
Experience in flexible films, medical packaging, or converting operations. * Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
Quick apply
Trevor, WI · On-site
$70K - $85K/yr
Experience in flexible films, medical packaging, or converting operations. * Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
Preferred Qualifications • Experience in flexible films, medical packaging, or converting operations. • Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or ...
Preferred Qualifications • Experience in flexible films, medical packaging, or converting operations. • Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or ...
Jackson, WI · On-site
$15.75 - $19/hr
Nucor supports its teammates with top-tier benefits like Medical, Dental, Vision, and Disability ... RF welder according to the production schedule. • Measure, review and layout materials per the ...
Jackson, WI · On-site
$15.75 - $19/hr
Nucor supports its teammates with top-tier benefits like Medical, Dental, Vision, and Disability ... RF welder according to the production schedule. • Measure, review and layout materials per the ...
Jackson, WI · On-site
$15.75 - $19/hr
Nucor supports its teammates with top-tier benefits like Medical, Dental, Vision, and Disability ... Cut material using Oteman or weld material using the vinyl RF welder. Inspect and examine work ...
Jackson, WI · On-site
$15.75 - $19/hr
Nucor supports its teammates with top-tier benefits like Medical, Dental, Vision, and Disability ... Cut material using Oteman or weld material using the vinyl RF welder. Inspect and examine work ...
... medical packaging, or converting operations. • Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies. • Experience supporting customer ...
... medical packaging, or converting operations. • Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies. • Experience supporting customer ...
Trevor, WI · On-site
$80K - $95K/yr
Experience in flexible films, medical packaging, or converting operations. * Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
Quick apply
Trevor, WI · On-site
$80K - $95K/yr
Experience in flexible films, medical packaging, or converting operations. * Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
Trevor, WI · On-site
$80K - $95K/yr
Ability to Travel (up to 10-20%) Preferred Qualifications Experience in flexible films, medical packaging, or converting operations. Experience with RF welding, heat sealing, extrusion, laminating ...
Trevor, WI · On-site
$80K - $95K/yr
Ability to Travel (up to 10-20%) Preferred Qualifications Experience in flexible films, medical packaging, or converting operations. Experience with RF welding, heat sealing, extrusion, laminating ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
... RF") components, RF microwave/microelectronic assemblies, and technologically advanced printed ... Use of all types of shop equipment so the ability to weld different types of metals, different ...
| Aspect | Medical Rf Welding | Medical Device Assembler |
|---|---|---|
| Required Certifications | RF welding certification, technical training | Assembly line training, technical skills |
| Work Environment | Manufacturing, cleanroom settings | Assembly lines, cleanroom or production areas |
| Industry Usage | Medical device manufacturing, specialized welding | Medical device assembly, general manufacturing |
Medical Rf Welders focus on using radio frequency welding techniques to join medical materials, requiring specific certifications and working primarily in manufacturing and cleanroom environments. Medical Device Assemblers perform general assembly tasks in medical device production, often with broader skills. While both roles are essential in medical manufacturing, Medical Rf Welders specialize in welding processes, whereas Medical Device Assemblers handle overall assembly tasks.
$70K - $85K/yr
Other
Re-posted 9 days ago
Description
Integration (Process Validation) Engineer
Medical Device Contract Manufacturer - Flexible Films & Packaging
Position Summary
The Integration (Process Validation) Engineer is responsible for leading and supporting process validation and manufacturing integration activities for medical device packaging, flexible film converting, and related manufacturing processes. This role ensures manufacturing processes are developed, validated, transferred, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer requirements, and internal quality standards.
The engineer will work cross-functionally with Operations, Quality, Design Engineering, and customers to support new product introductions, process improvements, equipment qualifications, and ongoing manufacturing validation activities.
Reporting Structure
Reports To: VP of Quality and Integration Engineering
Department: Integration Engineering
Essential Duties and Responsibilities
Develop and execute IQ, OQ, and PQ validation protocols and reports.
Lead validation activities for flexible film converting, RF welding, heat sealing, pouch manufacturing, printing, and labeling operations.
Perform process capability studies and statistical analysis to support validation activities.
Establish process windows, critical process parameters, and acceptance criteria.
Support new product introductions (NPI) from concept through commercial production.
Identify and implement process improvements focused on quality, efficiency, scrap reduction, and throughput.
Lead root cause investigations and corrective actions related to process performance.
Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP requirements, and customer-specific quality requirements.
Support internal, customer, and regulatory audits.
Project Management & Customer Communication
Lead cross-functional project activities related to process validation, equipment implementation, and new product integration.
Develop and manage project timelines, deliverables, and validation schedules to support customer and internal milestones.
Coordinate activities between Engineering, Quality, Operations, Supply Chain, and customer teams to ensure successful project execution.
Serve as a primary technical point of contact for customers during new product introductions, validation activities, process transfers, and ongoing manufacturing support.
Communicate project status, technical risks, validation progress, and issue resolution plans to internal leadership and customers.
Facilitate customer meetings, technical reviews, and validation planning discussions.
Support quotation reviews and provide technical input related to manufacturability, process capability, and validation requirements.
Collaborate with customers to understand product requirements, critical-to-quality characteristics, and regulatory expectations.
Support customer visits, audits, factory acceptance activities, and production trials as needed.
Requirements
Required Qualifications
Bachelor's degree in Engineering or related technical field required.
3+ years of engineering experience in a regulated manufacturing environment.
Experience with process validation in regulated manufacturing.
Working knowledge of IQ/OQ/PQ methodologies, statistical analysis, root cause analysis tools, and risk management methodologies.
Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.
Strong technical writing and documentation skills.
Preferred Qualifications
Experience in flexible films, medical packaging, or converting operations.
Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
Experience supporting customer audits and regulatory inspections.
Experience with EQMS systems.
Key Competencies
Strong analytical and problem-solving skills
Project management and organizational skills
Attention to detail and documentation accuracy
Effective communication and collaboration skills
Ability to manage multiple priorities in a fast-paced manufacturing environment
Customer-focused mindset
Sourced by ZipRecruiter
Plastics packaging film and sheet (including laminated) manufacturing
51 - 200 Employees
Trevor, WI, US
1955
