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Iso 11607 Jobs (NOW HIRING)

MRINetwork Jobs

Process Engineer

Providence, RI · On-site

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 ...

Lancesoft

Engr 2, Product Development

Warwick, RI · On-site

$50 - $55.11/hr

Familiarity with relevant packaging and quality standards such as ISO 11607, ISO 13485, and packaging related ASTM or ISTA standards (coursework or practical exposure acceptable). * Foundational ...

MRINetwork Jobs

Process Engineer

Providence, RI · On-site

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 ...

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 ...

Lancesoft INC

Sr Packaging Engineer

Lafayette, CO · On-site

$60 - $65/hr

ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) * Corresponding packaging ASTM standards * ISTA (International Safe Transit Association) standards

Saige Partners

Design Engineer

Huntley, 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 ...

Lancesoft INC

Sr Packaging Engineer

Lafayette, CO · On-site

$60 - $65/hr

Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and ...

Intellectt INC

Sr. Packaging Engineer

North Haven, CT · On-site

FDA 21 CFR Part 820, ISO 11607 & ISO 13485 Preferred: * Sterile Barrier Systems * ASTM, ISTA & EU MDR * New Product Introduction (NPI) Education: Bachelor's degree in Packaging, Mechanical ...

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 ...

Yochana

Packaging Engineer

Fremont, CA · On-site

Demonstrated understanding to ISO 11607-1 & 2, ISO 13485, ISO 16975, ICH Guidelines, and packaging-related ASTM or ISTA standards. * Demonstrated expertise in Design for Six Sigma (DFSS), statistical ...

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Iso 11607 information

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$87.7K

$142.5K

How much do iso 11607 jobs pay per year?

As of Aug 6, 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 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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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 August 2026, with employment types broken down into 90% Full Time, 2% Part Time, 6% Contract, and 2% Nights. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $87,669 per year, or $42.1 per hour.

Process Engineer

Management Recruiters of Tallahassee

Providence, RI

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 28 days ago

Job description

Title: Process Engineer

Location: Providence, RI

Our client, a leading global company specializing in custom solutions for the medical device and pharmaceutical industries, is seeking a Process Engineer for its Providence, RI location. The company designs and manufactures custom components using advanced plastic manufacturing technology and rigorous quality control standards.

Position Overview

The Process Engineer works closely with Operations, Quality, and Design teams to establish and sustain process capability across the company's Americas operations. This role applies engineering principles, statistical methods, and process development expertise to optimize product quality, ensure regulatory compliance, and drive continuous improvement from development through full-scale production.

Responsibilities and Functions:

  • Develop and execute IQ/OQ/PQ validation protocols for thermoforming and sealing processes in compliance with ISO 11607-2 and FDA process validation guidance.
  • Define critical process parameters (CPPs), Proven Acceptable Ranges (PAR), and Normal Operating Ranges (NOR) through structured development studies and DOE.
  • Lead statistical analysis of validation data including process capability (Cpk), targeting a minimum Cpk of 1.33 for critical parameters.
  • Own the full three-stage validation lifecycle: Process Design, Process Qualification, and Continued Process Verification.
  • Define, optimize, and standardize process parameters including temperature profiles, vacuum/pressure settings, plug assist timing, and cycle times.
  • Lead equipment qualification (IQ/OQ) for supporting equipment.
  • 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 software for DOE, capability studies, SPC, Gage R&R, and process data analysis.
  • Lead PFMEA, CAPA, and root cause investigations using structured methodologies (5-Why, Fishbone, DMAIC).
  • Partner cross-functionally with Operations, Quality, Supply Chain, and Design to align process improvements with business and customer requirements.
  • Train production teams on validated processes, in-process monitoring requirements, and critical quality attributes.
  • Apply Lean Manufacturing and Six Sigma principles to eliminate waste and improve process efficiency.

Qualifications:

Education:

  • Bachelor's degree in Mechanical, Manufacturing, Industrial, Chemical Engineering, or a related field. Advanced degrees or certifications (Six Sigma, CQE, CQA) are a plus.

Experience:

  • 3–5+ years in process engineering, manufacturing engineering, or operations engineering within a regulated industry; medical device experience strongly preferred.
  • Hands-on experience with process validation (IQ/OQ/PQ).
  • Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 — must be able to serve as subject matter expert during audits.
  • Demonstrated expertise in DOE and Six Sigma methodology; Black Belt certification preferred.
  • Proficiency with Minitab or equivalent statistical software for capability analysis, SPC, and DOE.
  • Experience with CAPA and structured problem-solving methodologies.
  • Familiarity with plastic manufacturing processes, polymer materials, heat sealing, and packaging equipment.
  • Strong leadership skills with the ability to influence across Operations, Quality, and Design.

Benefits:

  • 401(k) match program
  • Dental, health, and vision insurance
  • Paid time off

Location: Providence, RI — occasional travel to other sites may be required.

If you are interested in this position, please apply here or send your resume to matthew@mrrecruiter.com.

Equal Opportunity Employer Disclaimer

This organization is an Equal Opportunity Employer and is committed to creating an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability status, genetic information, protected veteran status, or any other characteristic protected by applicable law. Employment decisions are based solely on qualifications, merit, and business needs.