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Iec 60601 Jobs in Indiana (NOW HIRING)

BSI Group

At minimum, an awareness of the requirements of IEC 60601 family of standards and the risk management standard ISO 14971. * Understanding of the principles of design control and risk management.

BSI Prof Serv EHS West

At minimum, an awareness of the requirements of IEC 60601 family of standards and the risk management standard ISO 14971. * Understanding of the principles of design control and risk management.

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Iec 60601 information

What is IEC 60601?

IEC 60601 is an international series of technical standards for the safety and essential performance of medical electrical equipment. It ensures that medical devices are safe for both patients and operators by addressing electrical, mechanical, and functional safety. Compliance with IEC 60601 is mandatory in many countries for manufacturers who want to market their medical devices. The standard is regularly updated to reflect new technological advances and safety requirements.

What are some common challenges faced by professionals working with IEC 60601 compliance in medical device development?

Professionals working with IEC 60601 compliance often face challenges related to interpreting complex safety and performance requirements, as well as keeping up with frequent updates to the standard. Ensuring comprehensive documentation and rigorous testing to meet both basic and collateral standards can be time-consuming. Collaboration with cross-functional teams, such as regulatory, engineering, and quality assurance, is essential to address issues early and streamline the approval process. Additionally, adapting designs to accommodate evolving regional regulations can be a significant challenge.

What are the key skills and qualifications needed to thrive as a medical device compliance engineer (IEC 60601), and why are they important?

To excel as a Medical Device Compliance Engineer specializing in IEC 60601, a solid background in electrical engineering, regulatory standards, and risk management is required, often supported by a relevant engineering degree. Familiarity with IEC 60601-1 standards, test equipment, and compliance management software is essential for the role. Strong attention to detail, analytical thinking, and effective communication are soft skills that help navigate complex regulatory requirements and cross-functional collaboration. These competencies ensure medical devices are safe, effective, and meet global regulatory standards for patient safety.

What is the difference between Iec 60601 vs Medical Equipment Technician?

AspectIec 60601Medical Equipment Technician
CertificationsMay require IEC 60601 compliance knowledgeTypically certified in medical equipment repair and maintenance
Work EnvironmentDesign, testing, and compliance of medical electrical devicesRepair, calibrate, and maintain medical equipment in healthcare settings
Industry UsageStandards for medical electrical devicesHands-on technical support in hospitals and clinics

IEC 60601 is a standard ensuring safety and performance of medical electrical equipment, while a Medical Equipment Technician focuses on maintaining and repairing such devices. The technician applies IEC 60601 standards in their work but is primarily involved in practical device support rather than standard development or compliance testing.

What are popular job titles related to Iec 60601 jobs in Indiana?

For Iec 60601 jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Iec 60601 jobs in Indiana look for?

The top searched job categories for Iec 60601 jobs in Indiana are:

Iec 60601 jobs near you

Sr Systems Analysis Engineer, Medical Devices

Wright Technical Services

Bloomington, IN • On-site

$96K - $132K/yr

Full-time

Re-posted 20 days ago

Job description

Overview

This role is responsible for ensuring the overall functionality, safety, and efficacy of medical devices. Manages the design, development, and integration of firmware, software, hardware, electronics, and disposables.

Responsibilities:

  • Develop system architectures and specifications including: defining user requirements, design inputs, software requirements, feature descriptions, and user stories.
  • Conduct risk management activities including risk analysis for system, software, and cybersecurity.
  • Lead systems integration efforts across various engineering disciplines.
  • Ensures compliance with relevant industry standards including but not limited to ISO 13485, IEC 60601, IEC 62304, and ISO 14971.
  • Ability to effectively work and communicate in technical cross-functional teams to develop new products.
  • Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve work processes.

Required Qualifications:

  • BS Degree in Biomedical/Electrical, Systems/Software Engineering, or related field; Masters preferred
  • Minimum of 5 years of experience analyzing system requirements, design, and testing
  • Software integration, and black box testing methodologies
  • Experience with multi-tasking real-time operating system
  • Agile development experience
  • Strong working knowledge of IEC 60601, IEC 62304, ISO 13485, and ISO 14971
  • Experience and understanding of Design Controls and SDLC

Preferred Qualifications:

  • Familiarity with best practices of software development for medical devices
  • Strong Project Management skills
  • Familiarity with Agile, GitHub, and Azure Dev Ops

Physical Requirements:

  • Works under general office environmental conditions
  • Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
  • Ability to travel 25% of the time

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