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Iso 11607 Jobs (NOW HIRING)

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 ...

PDI

Principal Packaging Engineer

Woodcliff Lake, NJ · On-site

As a recognized expert, you will guide internal and external teams on the application of packaging standards (e.g., CCIT, ISO 11607, USP , USP , etc.), and represent the company in regulatory ...

krg technology inc

Packaging Engineer

Irvine, CA · On-site

Materials testing, documentation and ISO 11607 are also preferred for this role. Personal computer skills should include the ability to effectively use Windows word processing, project planning ...

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 ...

Remedy Robotics, Inc

Manufacturing Lead

San Francisco, CA · On-site

$175K - $235K/yr

Experience manufacturing disposable medical devices, including injection molding, sterile barrier packaging (ISO 11607), and EO or gamma sterilization validation * Experience developing or scaling ...

aspensurgical

Sr Design Engineer

Caledonia, MI · On-site

Working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards * Experience with IEC 60601 (Medical Electrical Equipment Safety and Performance ...

MML US Inc

Systems Engineer

San Diego, CA · On-site

$90K - $120K/yr

EU MDR, TGA EP, UK AIMDD, IEC 60601-1 series, IEC 62304, IEC 62366-1, IEC 20417, ISO 10993, ISO 10974, ISO 11607, ISO 14708-1 / EN 45502-1, AAMI TIR57, 21 CFR 15, RoHS, REACH, EU RED, ETSI series ...

Red Star

Sterile Packaging Manager

Larwill, IN · On-site

Knowledge of applicable standards including ISO 11607, ISO 11137, relevant ASTM standards, and quality system requirements. * Experience with manufacturing processes, process validation, statistical ...

Aspen Surgical

Sr Design Engineer

Caledonia, MI · On-site

Working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards * Experience with IEC 60601 (Medical Electrical Equipment Safety and Performance ...

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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 Jul 14, 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:
What states have the most Iso 11607 jobs? States with the most job openings for Iso 11607 jobs include:
What job categories do people searching Iso 11607 jobs look for? The top searched job categories for Iso 11607 jobs are:
Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in the United States as of July 2026, with employment types broken down into 1% Internship, 1% As Needed, 1% Full Time, 33% Part Time, 41% Contract, and 23% 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 & Artwork Designer

Packaging & Artwork Designer

kindeva

Northridge, CA

Other

Posted 15 days ago

Kindeva rating

6.8

Company rating: 6.8 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

We are seeking a detail-oriented Packaging and Artwork Designer with experience in the medical device or pharmaceutical industry. This role is responsible for the design, development, and management of compliant and visually engaging packaging and artwork that aligns with regulatory requirements, product branding, and usability standards.

ESSENTIAL DUTIES AND ROLE RESPONSIBILITIES

  • Design and develop primary and secondary packaging for medical devices, including labels, IFUs (Instructions for Use), cartons, and blister packs.
  • Create and manage artwork using Adobe Creative Suite (Illustrator, InDesign, Photoshop).
  • 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 ensure packaging accuracy and consistency.
  • Implement changes based on regulatory updates, product variations, and feedback from QA and operations.
  • Use artwork management systems (e.g., Esko, Kallik, Software) to handle version control and approval workflows.
  • Support packaging validation activities such as print proofs, color checks, and usability testing.
  • Maintain technical documentation and artwork specifications per QMS requirements.

REQUIRED SKILLS AND EXPERIENCE 

  • Bachelor’s degree in graphic design, Packaging Engineering, Biomedical Engineering, or related field.
  • 3+ years of experience in packaging and artwork design, preferably within the medical device or pharma industry.
  • Proficiency with Adobe Creative Suite and experience with artwork management software.
  • Strong understanding of regulatory requirements including UDI, ISO standards, MDR, and FDA guidelines.
  • Familiarity with labeling regulations and language localization requirements.
  • Strong attention to detail and excellent organizational skills.
  • Ability to manage multiple projects in a deadline-driven environment.

PERFERRED SKILLS & EXPERIENCE

  • Experience with packaging materials (paperboard, foil, Tyvek, etc.) and production methods.
  • Knowledge of Good Documentation Practices (GDP) and Quality Management Systems (QMS).
  • Understanding of sustainability trends in packaging.

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