Job Type Full-time Description Integration (Process Validation) Engineer Medical Device Contract Manufacturer - Flexible Films & Packaging Position Summary The Integration (Process Validation ...
Job Type Full-time Description Integration (Process Validation) Engineer Medical Device Contract Manufacturer - Flexible Films & Packaging Position Summary The Integration (Process Validation ...
Quality Engineering Technician
$21 - $30/hr
... medical device industry. With rapid expansion across all our locations, we continue to push the ... The Quality Engineer Technician position supports Quality Engineering techniques including: Problem ...
Quality Engineering Technician
$21 - $30/hr
... medical device industry. With rapid expansion across all our locations, we continue to push the ... The Quality Engineer Technician position supports Quality Engineering techniques including: Problem ...
Quality Engineering Technician
$21 - $30/hr
... medical device industry. With rapid expansion across all our locations, we continue to push the ... The Quality Engineer Technician position supports Quality Engineering techniques including: Problem ...
Quality Engineering Technician
$21 - $30/hr
... medical device industry. With rapid expansion across all our locations, we continue to push the ... The Quality Engineer Technician position supports Quality Engineering techniques including: Problem ...
Quality Engineering Technician
Hudson, WI · On-site
$21 - $30/hr
... medical device industry. With rapid expansion across all our locations, we continue to push the ... The Quality Engineer Technician position supports Quality Engineering techniques including: Problem ...
Quality Engineering Technician
Hudson, WI · On-site
$21 - $30/hr
... medical device industry. With rapid expansion across all our locations, we continue to push the ... The Quality Engineer Technician position supports Quality Engineering techniques including: Problem ...
Engineering Technician
Madison, WI · On-site
$30 - $34/hr
Perform high-level assembly of medical device subassemblies and components in a production ... Bachelor's degree in engineering or a related field, supported by an internship or co-op experience ...
New
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Engineering Technician
Madison, WI · On-site
$30 - $34/hr
Perform high-level assembly of medical device subassemblies and components in a production ... Bachelor's degree in engineering or a related field, supported by an internship or co-op experience ...
New
Biomedical Lab Technician (Intern)
Brookfield, WI · On-site
$24 - $31.75/hr
This internship supports engineering, additive manufacturing and medical device production activities in a regulated laboratory environment. This role is ideal for a motivated, detail-oriented ...
Biomedical Lab Technician (Intern)
Brookfield, WI · On-site
$24 - $31.75/hr
This internship supports engineering, additive manufacturing and medical device production activities in a regulated laboratory environment. This role is ideal for a motivated, detail-oriented ...
Quality Engineer II
$70K - $90K/yr
... R, control plans, first article inspection, criteria, etc.). • Directs workers engaged in ... Knowledge of the medical device manufacturing industry is highly preferred. * Experience with CNC ...
Quality Engineer II
$70K - $90K/yr
... R, control plans, first article inspection, criteria, etc.). • Directs workers engaged in ... Knowledge of the medical device manufacturing industry is highly preferred. * Experience with CNC ...
Quality Engineer II
Kenosha, WI · On-site
$70K - $90K/yr
... R, control plans, first article inspection, criteria, etc.). • Directs workers engaged in ... Knowledge of the medical device manufacturing industry is highly preferred. * Experience with CNC ...
Quality Engineer II
Kenosha, WI · On-site
$70K - $90K/yr
... R, control plans, first article inspection, criteria, etc.). • Directs workers engaged in ... Knowledge of the medical device manufacturing industry is highly preferred. * Experience with CNC ...
Senior Manufacturing Engineer
$78K - $124K/yr
... we'd love to hear from you. * Management of new and existing medical device programs ... Prepare engineering reports and communicate results to both internal (corporate) & external parties ...
Senior Manufacturing Engineer
$78K - $124K/yr
... we'd love to hear from you. * Management of new and existing medical device programs ... Prepare engineering reports and communicate results to both internal (corporate) & external parties ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
Software Engineer Internships
Racine, WI · On-site
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
Software Engineer Internships
Racine, WI · On-site
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
Software Engineer Internships
Kenosha, WI · On-site
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
Software Engineer Internships
Kenosha, WI · On-site
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
Software Engineer Internships
Madison, WI · On-site
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
Software Engineer Internships
Madison, WI · On-site
By submitting your interest, you'll be among the first to know when internship opportunities open ... Producing documentation to support medical device regulatory processes Who This Is For * Students ...
Internship R D Engineer Medical Device information
What does an Internship R&D Engineer in Medical Device do?
An Internship R&D Engineer in Medical Device assists in the research and development of new medical technologies and products. Their responsibilities typically include supporting senior engineers in designing, testing, and improving medical devices, conducting experiments, collecting and analyzing data, and preparing technical documentation. Interns also learn about regulatory standards and industry best practices while working as part of a multidisciplinary team. This role is ideal for students or recent graduates looking to gain hands-on experience in medical device innovation.
What are the key skills and qualifications needed to thrive as an Internship R&D Engineer in Medical Devices, and why are they important?
To thrive as an Internship R&D Engineer in Medical Devices, you generally need a background in biomedical engineering or a related field, with strong analytical and problem-solving abilities. Familiarity with CAD software, lab equipment, and basic knowledge of regulatory standards like ISO 13485 is important, and prior internships or relevant coursework can be advantageous. Attention to detail, effective communication, and collaborative teamwork skills help you contribute meaningfully to projects and navigate cross-functional environments. These skills ensure you can support innovative product development while adhering to strict safety and quality standards in the medical device industry.
What is the difference between Internship R&D Engineer Medical Device vs R&D Engineer Medical Device?
| Aspect | Internship R&D Engineer Medical Device | R&D Engineer Medical Device |
|---|---|---|
| Qualifications | Enrolled in or recent graduate of engineering/biomedical programs | Bachelor's or Master's in engineering/biomedical fields |
| Work Environment | Internship programs, entry-level projects, supervised tasks | Full-time, independent project work, team collaboration |
| Responsibilities | Assisting in research, testing, and documentation | Design, develop, and improve medical device products |
| Industry Usage | Commonly used for training and entry-level experience | Core role in product development and innovation |
In summary, the Internship R&D Engineer Medical Device is an entry-level position designed for students or recent graduates gaining initial industry experience. The R&D Engineer Medical Device is a full-time professional role with greater responsibilities in product development and innovation within the medical device industry.
What types of projects or tasks can an Internship R&D Engineer expect to work on in the medical device industry?
As an Internship R&D Engineer in the medical device industry, you can expect to be involved in a variety of projects such as prototyping new device concepts, conducting laboratory experiments, performing data analysis, and supporting design verification and validation activities. Interns often collaborate closely with multidisciplinary teams, including senior engineers, regulatory specialists, and clinicians, to help solve real-world problems and improve patient outcomes. This hands-on experience provides valuable insight into the product development lifecycle and offers opportunities to contribute to meaningful projects that can enhance your technical and professional skills.
What cities in Wisconsin are hiring for Internship R&D Engineer Medical Device jobs? Cities in Wisconsin with the most Internship R&D Engineer Medical Device job openings:
Full-time
Posted 22 days ago
Job description
Job Type
Full-time
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
Full-time
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
About Vonco Products
Sourced by ZipRecruiter
Industry
Plastics packaging film and sheet (including laminated) manufacturing
Company size
51 - 200 Employees
Headquarters location
Trevor, WI, US
Year founded
1955