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Iso 11607 Jobs in California (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 ...

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 ...

krg technology inc

Packaging Engineer

Irvine, CA

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 ...

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 ...

Orthofix

Packaging Engineer II

Carlsbad, CA · On-site

Familiarity with ASTM D4169, ISO 11607, and ISO 11137 PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS The physical requirements listed in this section include, but are not limited, to the motor ...

Imperative Care

Sr Packaging Engineer

Campbell, CA · On-site

$132K - $158K/yr

Experience developing and executing packaging validation protocols and reports in accordance with ISO 11607 and ASTM standards * Experience reviewing supplier drawings, engineering specifications ...

Imperative Care

Sr Packaging Engineer

Campbell, CA · On-site

$132K - $158K/yr

Experience developing and executing packaging validation protocols and reports in accordance with ISO 11607 and ASTM standards * Experience reviewing supplier drawings, engineering specifications ...

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Showing results 1-20

All JobsIso 11607 JobsIso 11607 Jobs in California

Iso 11607 information

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 challenges do professionals face when working with ISO 11607 compliance?

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 skills and qualifications are needed to work with ISO 11607?

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.
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Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in California as of August 2026, with employment types broken down into 90% Full Time, 2% Part Time, 6% Contract, and 2% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Sr. Test Engineer - Design Verification Testing

DivIHN Integration Inc

San Diego, CA • On-site

$62 - $66/hr

Contractor

Posted 23 days ago

Job description

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at https://divihn.com/find-a-job/ to learn more and view our open positions.

 
Please apply or call one of us to learn more

For further inquiries about this opportunity, please contact one of our Talent Specialists, Ragu at (224) 704 1713 or Justeen at (224)394 4903.
 
 
Title:  Sr. Test Engineer - Design Verification Testing
Location: San Diego, CA 
Duration:6 Months with  possible extension
Travel Required: Up to 25%
 
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
 
Role Summary:
This is a temporary position to provide backup coverage for a team member. The role focuses on mechanical and electromechanical design verification testing for CGM applicator and wearable systems. Key responsibilities include deployment mechanism verification, environmental conditioning, sterilization impact assessment, force measurements, and IPX8 water ingress testing.
 
Description:
  • Collaborate with Mechanical Engineering, Sterilization, Packaging, and cross-functional teams to define product requirements, test strategies, and use cases for CGM applicator and wearable systems.
  • Lead and execute design verification strategies for mechanical and electromechanical assemblies, including applicator deployment mechanisms, sensor insertion systems, and housing retention features.
  • Design and implement cost-effective test methods for mechanical and electromechanical systems, including force measurements, deployment testing, water ingress protection (IPX8), and environmental conditioning.
  • Create and maintain verification documentation, including test plans, protocols, and reports in compliance with ISO 13485, 21 CFR 820, and applicable IEC/ASTM standards.
  • Analyze test results using statistical techniques (e.g., t-test, ANOVA, tolerance intervals, equivalence testing), document findings accurately, and provide improvement recommendations.
  • Plan and execute assessment of sterilization impact on mechanical performance and sensor deployment integrity.
  • Support distribution simulation, environmental conditioning, and packaging verification activities in coordination with packaging engineering.
  • Seek opportunities to improve processes, test equipment, and methods, including elimination of non-value-added activities or automation of tedious tasks and tests.
  • Design, fabricate, and troubleshoot test fixtures and equipment.
Key Qualifications:
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related discipline (5 years of experience would be great)
  • Experience with mechanical testing methods (force measurement, deployment mechanisms, environmental testing)
  • Familiarity with IEC 60601-1, ASTM D4169, ASTM D4332, ISO 11607
  • Statistical analysis experience (JMP, Minitab)
  • Medical device industry experience preferred
Required Skills (top 3 non-negotiables):
  1. Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline
  2. Experience with mechanical testing methods including force measurement, displacement, deployment mechanisms, and environmental testing (temperature, humidity, vibration, shock).
  3. self-driven, technical person with strong interpersonal skills and the ability to manage multiple projects simultaneously.
Preferred Skills (nice to have)
  1. Familiarity with relevant standards such as IEC 60601-1, IEC 60601-1-11, ASTM D4169, ASTM D4332, ISTA 3A, and ISO 11607.
What makes you successful: 
  • You have a bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
  • Experience with mechanical testing methods including force measurement, displacement, deployment mechanisms, and environmental testing (temperature, humidity, vibration, shock).
  • Familiarity with relevant standards such as IEC 60601-1, IEC 60601-1-11, ASTM D4169, ASTM D4332, ISTA 3A, and ISO 11607.
  • Knowledge of at least one scripting or high-level programming language (e.g., Python, MATLAB, VBA) for data analysis or test automation.
  • Capability to interpret regulatory frameworks and standards and apply them to product design verification and processes.
  • Strong analytical and problem-solving skills with experience in statistical analysis tools (e.g., JMP, Minitab).
  • Excellent communication skills, both written and verbal, with the ability to present technical data to cross-functional and leadership audiences.
  • You  are a self-driven, technical person with strong interpersonal skills and the ability to manage multiple projects simultaneously.
Interview  
  • 2  rounds 
  • Web Conference (Zoom/ TEAMs)

About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.