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Iso 11607 Jobs (NOW HIRING)

Intellectt INC

Packaging Engineer

Boston, MA · On-site

Support regulatory compliance efforts with FDA and ISO standards (ISO 13485, ISO 11607) * Collaborate with cross-functional teams including Quality, Regulatory, Manufacturing, and Supply Chain

Kelly Services

Packaging Engineer

Jacksonville, FL

Apply appropriate industry standards such as ISO 11607-2, to specify and validate packaging equipment and packaging manufacturing processes to determine appropriate sourcing, purchasing, installation ...

MRINetwork Jobs

Process Engineer

Providence, RI

Ensure all processes comply with ISO 13485, ISO 11607-1/2, and FDA 21 CFR Part 820 (QMSR); serve as subject matter expert during internal, customer, and regulatory audits. * Use Minitab or equivalent ...

Saige Partners

Design Engineer

Dekalb, IL · On-site

Partner with Quality and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, ISO 11607, ASTM, and other applicable standards. Support packaging validation activities, including sample ...

Saige Partners

Design Engineer

Huntley, IL

Partner with Quality and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, ISO 11607, ASTM, and other applicable standards. Support packaging validation activities, including sample ...

aspensurgical

Sr Packaging Engineer

Caledonia, MI · On-site

Lead and execute packaging validations for new product development and sustaining changes in compliance with ISO 11607 and applicable regulatory requirements. * Design, optimize, and validate ...

Aspen Surgical

Sr Packaging Engineer

Caledonia, MI · On-site

Lead and execute packaging validations for new product development and sustaining changes in compliance with ISO 11607 and applicable regulatory requirements. * Design, optimize, and validate ...

kindeva

Packaging & Artwork Designer

Northridge, CA · On-site

Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...

kindeva

Packaging & Artwork Designer

Northridge, CA · On-site

Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...

kindeva

Packaging & Artwork Designer

Northridge, CA

Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...

kindeva

Packaging & Artwork Designer

Northridge, CA

Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...

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All JobsIso 11607 Jobs

Iso 11607 information

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$29.5K

$87.7K

$142.5K

How much do iso 11607 jobs pay per year?

As of Jun 15, 2026, the average yearly pay for iso 11607 in the United States is $87,669.00, according to ZipRecruiter salary data. Most workers in this role earn between $62,500.00 and $112,500.00 per year, depending on experience, location, and employer.

What is the difference between Iso 11607 vs Packaging Technician?

AspectIso 11607Packaging Technician
CertificationsStandards for sterile packagingOften certified in packaging processes
Work EnvironmentManufacturing and sterile packaging facilitiesPackaging lines, production areas
Industry UsageMedical device and pharmaceutical packagingMedical device, pharmaceutical, and consumer goods
Primary FocusEnsuring packaging meets sterilization and safety standardsAssembling, inspecting, and packaging products

While Iso 11607 refers to standards for sterile packaging, a Packaging Technician focuses on executing packaging processes according to those standards. The technician ensures products are properly packaged, inspected, and ready for sterilization, aligning with Iso 11607 requirements to ensure safety and compliance.

What are the main challenges faced by professionals working with ISO 11607 compliance in medical device packaging?

Professionals ensuring ISO 11607 compliance often face challenges in interpreting and applying the standard’s requirements to a variety of packaging materials and processes. Keeping up with evolving regulatory expectations, conducting thorough risk assessments, and validating packaging systems can be complex and time-consuming. Collaboration with cross-functional teams including R&D, quality assurance, and manufacturing is crucial to ensure that all packaging meets both regulatory and functional standards. Additionally, maintaining detailed documentation and responding to audit findings are key parts of the role.

What is ISO 11607?

ISO 11607 is an international standard that specifies requirements and test methods for packaging materials and systems used to sterilize medical devices. It ensures that packaging maintains sterility up to the point of use and provides guidance on validation processes. The standard is divided into two parts: Part 1 covers requirements for materials and design, while Part 2 focuses on packaging process validation. Compliance with ISO 11607 is critical for manufacturers to ensure patient safety and meet regulatory requirements.

What are the key skills and qualifications needed to thrive as an ISO 11607 Compliance Specialist, and why are they important?

To thrive as an ISO 11607 Compliance Specialist, you need expertise in packaging validation, regulatory standards for sterile medical devices, and a background in engineering, quality assurance, or a related scientific field. Familiarity with technical tools such as validation protocols, statistical analysis software, and document control systems is typically required, as well as knowledge of ISO 11607-1 and ISO 11607-2 standards. Strong attention to detail, analytical thinking, and effective communication help ensure compliance and successful collaboration with cross-functional teams. These skills ensure that medical device packaging meets regulatory requirements, safeguarding patient safety and supporting product quality.
More about Iso 11607 jobs
What cities are hiring for Iso 11607 jobs? Cities with the most Iso 11607 job openings:
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Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in the United States as of June 2026, with employment types broken down into 3% Internship, 2% As Needed, 3% Full Time, 56% Part Time, 5% Temporary, and 31% Nights. Highlights an 92% Physical, 5% Hybrid, and 3% Remote job distribution, with an average salary of $87,669 per year, or $42.1 per hour.
Packaging Engineer

Packaging Engineer

Intellectt INC

Boston, MA • On-site

Contractor

Posted 21 days ago

Job description

Job Title: Senior Packaging Engineer 

Location: Boston, MA

Duration: 12+ Months

Experience: 5 Years

Job Summary:

We are seeking an experienced Senior Packaging Engineer with a strong background in medical device packaging to support design, validation, and compliance activities. The ideal candidate will bring hands-on expertise in sterile packaging systems, labeling, and regulatory standards, along with the ability to drive packaging improvements and compliance initiatives.

Key Responsibilities:

  • Design and develop medical device packaging systems, including material selection and sterile barrier systems
  • Lead and execute packaging validation activities including IQ/OQ/PQ, transit testing, and aging studies
  • Ensure compliance with medical device labeling requirements, including UDI (Unique Device Identification)
  • Implement and validate barcode systems in alignment with GS1 standards
  • Support regulatory compliance efforts with FDA and ISO standards (ISO 13485, ISO 11607)
  • Collaborate with cross-functional teams including Quality, Regulatory, Manufacturing, and Supply Chain
  • Participate in packaging remediation projects and continuous improvement initiatives
  • Assist in post-acquisition integration activities related to packaging and labeling
  • Manage label conversions, barcode updates, and compliance gap assessments

Required Qualifications:

  • Bachelor’s degree in Engineering or a related field
  • 5–10 years of experience in medical device packaging engineering
  • Strong expertise in packaging design and sterile barrier systems
  • Hands-on experience with packaging validation (IQ/OQ/PQ, transit testing, aging studies)
  • Experience with UDI, labeling compliance, and barcode implementation
  • Working knowledge of GS1 standards
  • Familiarity with FDA regulations and ISO standards (ISO 13485, ISO 11607)

Preferred Qualifications:

  • Experience with post-acquisition integration projects
  • Background in packaging remediation and compliance gap closure
  • Experience with label conversions and barcode updates
  • Ability to work in fast-paced, cross-functional environments