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Iso 11607 Jobs in Michigan (NOW HIRING)

aspensurgical

Design Engineer

Caledonia, MI

Preferred working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards * Strong familiarity with the methods of Risk Management and Failure Mode Effects ...

aspensurgical

Sr Design Engineer

Caledonia, MI

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 ...

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 ...

Aspen Surgical

Design Engineer

Caledonia, MI · On-site

Preferred working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards * Strong familiarity with the methods of Risk Management and Failure Mode Effects ...

spidf

Engineer, Manufacturing (ISO Poly Foam)

Portage, MI · On-site

$68K - $88K/yr

Engineer, Manufacturing (ISO Poly Foam) FLSA STATUS: Exempt REPORTS TO: Chief Technical Manager, Manufacturing Coordination SUMMARY The ISO Poly Foam Engineer develops, optimizes, and supports ...

spidf

Engineer, Manufacturing (ISO Poly Foam)

Portage, MI · On-site

$68K - $88K/yr

Engineer, Manufacturing (ISO Poly Foam) FLSA STATUS: Exempt REPORTS TO: Chief Technical Manager, Manufacturing Coordination SUMMARY The ISO Poly Foam Engineer develops, optimizes, and supports ...

Progressive Metal Mfg Co

QUALITY ENGINEER

Ferndale, MI · On-site

$67K - $86K/yr

Support and maintain compliance with IATF 16949, ISO 9001, ISO 14001, AS9100 (as applicable), customer-specific requirements, and applicable regulatory requirements. * Participate in internal ...

World Tek Industries, LLC

Quality Manager

Romulus, MI · On-site

$120K - $135K/yr

Own and maintain the Quality Management System (QMS) , ensuring audit readiness for ISO 9001 , AS9100 and ISO 13485 standards. * Metrology Management: Direct the calibration of all precision ...

Magnachek

Quality Manager

Madison Heights, MI

ISO 17025 is preferred, but not necessary. Quality Supervisor is responsible for handling all quality issues. This is a "hands-on" position spent on the production floor to promote our quality ...

Magnachek

Quality Manager

Madison Heights, MI · On-site

ISO 17025 is preferred, but not necessary. Quality Supervisor is responsible for handling all quality issues. This is a "hands-on" position spent on the production floor to promote our quality ...

TriMas Corporation

Senior Quality Engineer

Clinton, MI · On-site

$87K - $118K/yr

Develop, and review IQ/OQ/PQ ValidationProtocols, Summary Reports, Validation Master Plans for products, andmanufacturing processes per ISO 13485, and 21 CFR 820 regulations. SupportQuality ...

Synerfac Technical Staffing

Quality Engineer

Litchfield, MI · On-site

$70K - $90K/yr

... QS9000, ISO 14001 and Customer expectations - Must have Quality Engineering experience - Must have Automotive Manufacturing experience. - Must have experience with QS9000, ford Q1, ISO 14001 By ...

MILTON MANUFACTURING INC

Quality Lead

Detroit, MI · On-site

$90 - $130/hr

Serves as management representative for ISO 9001 certification efforts, including readiness assessments, gap analysis, and coordination with external certification auditors. * Establishes and ...

Apolis

LabWare LIMS Systems Engineer

Kalamazoo, MI · On-site

ISO and/or GLP familiarity. * Business analysis and project management proficiency. * Strong verbal and written communication skills with the ability to express complex technical concepts in business ...

Autokiniton

Quality Engineer

Plymouth, MI · On-site

$68K - $88K/yr

Responsible for reading and understanding the ISO-9001:2015, ISO-17025:2017, and ISO-14001 procedures. * Excellent organizational, analytical and communication skills. * Effective email and ...

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All JobsIso 11607 JobsIso 11607 Jobs in Michigan

Iso 11607 information

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.

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 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 popular job titles related to Iso 11607 jobs in Michigan?

For Iso 11607 jobs in Michigan, the most frequently searched job titles are:

What job categories do people searching Iso 11607 jobs in Michigan look for?

The top searched job categories for Iso 11607 jobs in Michigan are:

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Iso 11607 jobs near you

Design Engineer

aspensurgical

Caledonia, MI

Full-time

Re-posted 11 hours ago

Job description

Summary

The Design Engineer is responsible for Designing 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:

 

Medical Device Product Development

  • Lead projects and evaluate design changes related to existing products to maintain business continuity.
  • Develop and evaluate medical device designs which meet defined product requirements and are optimized for safe clinical solutions, production, reliability, and overall cost effectiveness for the business.
  • Execute medical device design history file activities to be compliant with applicable regulations.
  • Provide technical support to other departments and individuals as necessary in the exploration of new opportunities, complaints etc.
  • Evaluate proposed changes to existing products and complete deliverables required to implement change through individual efforts or cross-functional teams.
  • Ensure 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

  • Manage project schedules, budgets, mitigating risks, and efficient solutioning of issues.
  • Communicate project plans, track tasks, and manage time to meet project deadlines.
  • Communicate with leaders status of projects in a clear and 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.

What You Need to Succeed in This Position

  • Bachelor of Science Degree in Engineering is required
  • A minimum of three to five years of medical device engineering experience
  • Regulated industry experience that includes, but not limited to, FDA 21CFR820.30, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements.
  • Preferred working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards
  • 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
  • Preferred 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.
  • Strong teamwork and effective communication to enhance a positive culture.
  • Ability to effectively communicate and collaborate globally.
  • Drives a culture of clinical safety and quality first.
  • Mitigates risks during the lifetime of the projects
  • Engage in continuous education to maintain job knowledge in medical device design & development
  • Excellent computer skills including but not limited to Microsoft Office Suite
  • Ability to travel up to 15% required.

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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