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Iso 11607 Jobs (NOW HIRING)

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 ...

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 ...

Orthofix

Packaging Engineer II

Carlsbad, NM · 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 ...

Amcor plc

Manufacturing Quality Engineer

New London, WI · On-site

$68K - $88K/yr

Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements and ISO-11607 * Support manufacturing units with analyzing failures, preventive and corrective ...

Medline

Validation Engineer

Hartland, WI

$73K - $110K/yr

Experience with ISO 13485 and ISO 11607 standards. * Experience with Measurement System Analysis. * Experience with Minitab statistical analysis software. * Experience with root cause analysis.

Medline

Validation Engineer

Hartland, WI

$73K - $110K/yr

Experience with ISO 13485 and ISO 11607 standards. * Experience with Measurement System Analysis. * Experience with Minitab statistical analysis software. * Experience with root cause analysis.

Medline

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

Experience with ISO 13485 and ISO 11607 standards. * Experience with Measurement System Analysis. * Experience with Minitab statistical analysis software. * Experience with root cause analysis.

Amcor

Manufacturing Quality Engineer

New London, WI · On-site

$68K - $88K/yr

Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements and ISO-11607 * Support manufacturing units with analyzing failures, preventive and corrective ...

Dexcom

Packaging Engineer 2

San Diego, CA · On-site

You have an understanding of industry standards, such as ASTM D4169, ISO 11607, ISO TS 16775, ISO 13485 and ISTA test standards. * You have a deep understanding of various material properties and ...

Dexcom, Inc.

Packaging Engineer 2

San Diego, CA · On-site

You have an understanding of industry standards, such as ASTM D4169, ISO 11607, ISO TS 16775, ISO 13485 and ISTA test standards. * You have a deep understanding of various material properties and ...

CONMED

Packaging Engineer II

Largo, FL

Familiarity with ISO 11607 and applicable regulatory standards and Engineering or manufacturing systems (ERP/MES) Expected Travel 0-20% This position is not eligible for employer-visa sponsorship ...

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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.
Sr Design Engineer

Sr Design Engineer

Aspen Surgical

Caledonia, MI • On-site

Full-time

Posted 5 days ago

Job description

About Aspen
We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people's lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.
Summary
The Sr Design Engineer is responsible for Design medical devices to support the growth, cost profile, and business continuity of Aspen Surgical products while working in a collaborative team environment.
In This Position, You Will Have the Opportunity to:
  • Support design tasks associated with global revenue growth and margin improvement projects
  • Support organic growth functions of acquisitions and other business migrations
  • Support sustaining engineering functions of the organization to maintain business continuity

Medical Device Product Development
  • Execute medical device design history file activities to be compliant with applicable regulations
  • Conduct the development and evaluation of medical device designs which meet defined product requirements and that are optimized for safe clinical solutions, production, reliability, and overall cost effectiveness for the business
  • Provide technical assistance to various departments and individuals as necessary in the exploration of new opportunities
  • Evaluate proposed changes to existing products and complete deliverables required to implement the change through individual efforts or cross-functional teams
  • Ensure that product changes meet regulations as well as internal and external customer requirements
  • Troubleshoot and problem-solve efforts related to product design.
  • Conduct thorough engineering and data analysis.

Project Management
  • Responsible for project schedules, budgets, mitigating risks, and efficient solutioning of issues
  • Recommend and communicate project plans, track tasks, and manage time to meet project deadlines
  • Executive presence for communicating with leaders in a clear efficient manner

Global Collaboration
  • Work closely with the portfolio managers to understand clinical and commercial impacts.
  • Strong communication skills to convey design concepts to clinicians to obtain design direction
  • Work with manufacturing throughout the development phases to ensure that products are produced in a safe, efficacious, and quality manner while keeping within established time frames
  • Work with finance to develop product costing to understand impacts of material/design selections
  • Interface with vendors, manufacturing facilities, and various internal groups to resolve design and manufacturing issues of new and existing products
  • Provide peer mentoring and guidance to other engineers throughout the company

What You Need to Succeed in This Position
  • Bachelor of Science Degree in Engineering or closely related 4-year technical degree is required
  • 7+ years of medical device engineering experience preferred
  • PMP certification preferred
  • Regulated industry experience that includes, but not limited to, FDA 21CFR820.30, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements.
  • 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 Requirements) and/or IEC 62304 (Medical Device Software Lifecycle Requirements) preferred.
  • Strong familiarity with the methods of Risk Management and Failure Mode Effects Analysis (FMEA)
  • Working knowledge of design history & technical file within an auditing environment.
  • Working knowledge of statistical analysis of data used to meet or define design criteria
  • Project management experience to effectively manage and complete multiple projects simultaneously
  • Involvement with invention disclosures or patents
  • Business case development for product costing as it pertains to design
  • Preferred experience using engineering programs such as SolidWorks, Minitab, TOPS, similar.
  • Teamwork, effective communication, and positive attitude required to fit & grow culture
  • Effectively handles global interactions and collaborations while managing cultural differences.
  • Models clinical safety and quality first mindset
  • Takes initiative and proactively mitigates risks
  • Continuous education focused to advance job knowledge in medical device design & development
  • Excellent computer skills including but not limited to Microsoft Office Suite
  • On site job located in Caledonia, MI with 15% expected travel

We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.

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