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Research And Development Engineer Medical Device Jobs in Colorado

... research / development / engineering. 3) PMP certification. Desired Skills: 1) FDA or other regulatory environment. 2) Medical device projects. 3) Six Sigma or LEAN certifications. Additional ...

... medical device products - three to four projects at one time. This will involve gathering ... related to product research / development / engineering. 3) PMP certification. Additional ...

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Research And Development Engineer Medical Device information

What does a research and development engineer do in the medical device industry?

A Research and Development (R&D) Engineer in the medical device industry is responsible for designing, developing, and testing new medical devices and technologies. They work closely with cross-functional teams to ensure products meet regulatory standards, are safe for patient use, and address clinical needs. Their tasks may include prototyping, conducting experiments, analyzing data, and collaborating with manufacturing teams to bring products from concept to market. R&D Engineers also stay updated on technological advancements and regulatory changes to ensure innovation and compliance.

What are the key skills and qualifications needed to thrive as a research and development engineer in the medical device industry?

To excel as a Research and Development Engineer in Medical Devices, you need a solid background in biomedical engineering or a related field, strong problem-solving skills, and experience with product development cycles. Familiarity with CAD software, prototyping tools, regulatory standards like ISO 13485, and relevant certifications (such as Six Sigma) is highly valued. Excellent teamwork, creativity, and effective communication are crucial soft skills for collaborating across multidisciplinary teams and driving innovation. These competencies ensure the design and launch of safe, effective, and compliant medical devices that improve patient outcomes.

What are some common challenges faced by research and development engineers in the medical device industry?

Research and Development Engineers in the medical device industry often face challenges such as navigating complex regulatory requirements, managing tight project timelines while ensuring product safety and efficacy, and collaborating with cross-functional teams like quality assurance and clinical affairs. Additionally, adapting to rapid technological advancements and integrating feedback from clinicians and end-users into the design process can be demanding. These challenges require strong problem-solving skills, adaptability, and effective communication to deliver innovative and compliant medical devices.

What is the difference between Research And Development Engineer Medical Device vs Quality Assurance Engineer Medical Device?

AspectResearch And Development Engineer Medical DeviceQuality Assurance Engineer Medical Device
Primary FocusDesigning, developing, and testing new medical device productsEnsuring products meet quality standards and regulatory requirements
Required CredentialsEngineering degree, knowledge of product developmentEngineering or science degree, knowledge of quality systems
Work EnvironmentResearch labs, product development teamsManufacturing facilities, quality control departments
Industry UsageInvolved in innovation and product creationInvolved in compliance, validation, and process improvement

While both roles require engineering knowledge and are integral to the medical device industry, Research And Development Engineers focus on creating and testing new products, whereas Quality Assurance Engineers ensure these products meet safety and quality standards throughout production.

What are popular job titles related to Research And Development Engineer Medical Device jobs in Colorado?

For Research And Development Engineer Medical Device jobs in Colorado, the most frequently searched job titles are:

What cities in Colorado are hiring for Research And Development Engineer Medical Device jobs?

Cities in Colorado with the most Research And Development Engineer Medical Device job openings:

Clinical Engineering Medical Device Security Engineer

CommonSpirit Health

Englewood, CO

$45.26 - $74.67/hr

Full-time

Re-posted 11 days ago


CommonSpirit Health rating

7.0

Company rating: 7.0 out of 10

Based on 533 frontline employees who took The Breakroom Quiz

414th of 887 rated healthcare providers


Job description


Job Summary and Responsibilities

As our Clinical Engineering Medical Device Security Engineer I, you will play a critical role in safeguarding CommonSpirit's extensive medical device environment, ensuring both device integrity and patient safety. You will be at the forefront of mitigating cybersecurity vulnerabilities and threats across our system, contributing to the development and testing of robust remediation strategies. This position is vital for maintaining the resilience of our medical technology infrastructure against evolving cyber risks and ensuring compliance with stringent cybersecurity regulations.

Every day you will collaborate dynamically with cross-functional teams to implement effective mitigation strategies, addressing identified medical device security vulnerabilities. A core responsibility will be to develop and meticulously test medical device security patching and remediation instructions, ensuring risks are mitigated without compromising device reliability or patient safety. In the event of a security incident, you will take the lead in system-wide remediation efforts, coordinating swift responses to return devices to service and implement preventative measures. Furthermore, you will conduct comprehensive assessments of system-wide medical devices, identifying potential risks through detailed reviews of MDS2 forms and information from OEMs, and resolve technical challenges while supporting field technicians.

To be successful in this role, you will possess a strong foundation in medical device cybersecurity, risk assessment, and technical remediation. Your expertise in vulnerability management, incident response, and regulatory compliance (e.g., relevant cybersecurity standards and guidelines) will be essential. We are seeking a proactive and detail-oriented engineer with a proven ability to collaborate effectively, troubleshoot complex technical issues, and develop robust solutions that protect critical healthcare infrastructure and ensure continuous patient care.

  • Collaborate with cross-functional teams to implement mitigation strategies that address medical device security vulnerabilities and threats.
  • Develop and test medical device security patching and remediation instructions to mitigate risks while also maintaining the integrity of the devices to ensure device reliability and patient safety.
  • In the event of a security incident, lead system wide remediation efforts by coordinating with cross-functional teams to return the devices to service and to implement measures that will prevent future attacks.
  • Conduct comprehensive assessments of system wide medical devices to identify potential security risks and vulnerabilities by reviewing MDS2 forms, and obtaining information from medical device OEMs.
  • Ensure that medical devices comply with relevant cybersecurity regulations, standards and guidelines.
  • Resolve technical challenges and provide support to field technicians.

The job summary and responsibilities listed above are designed to indicate the general nature of the work performed within this job. They are not designed to contain or be interpreted as a comprehensive inventory of all job responsibilities required of employees assigned to this job. Employees may be required to perform other duties as assigned.

Job Requirements

Required:

  • Bachelors Other HTM, Computer Science, Technology, Business disciple upon hire or equivalent professional experience required
  • 2-4 years experience working in healthcare/IT Security, System Administration, Software Development or related field.
  • 1-2  years experience working in a healthcare/medical environment
  • Experience working with specialized medical equipment in a healthcare setting.
  • Experience with Cybersecurity and Infrastructure Security Agency (CISA), HIPAA/HITECH compliance standards.
  • Valid Drivers License

Preferred:

  • Experience working with the software development life cycle or project management methodologies
  • Certified Radiology Equipment Specialists (CRES)
  • Certified Biomedical Equipment Technician (CBET)
  • Certified Healthcare Tech Manager (CHTM)
  • CompTIA A+ Certification (A-PLUS)
  • CompTIA Network + (NTWK-PLUS)

This position requires participation in a rotational on-call schedule, including nights, weekends, and holidays. Candidates must be available to respond to urgent service needs outside of regular business hours and may be required to return to the facility on short notice.

Where You'll Work

Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation’s largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 137 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit has more than 157,000 employees, 45,000 nurses and 25,000 physicians and advanced practice providers across 24 states and contributes more than $4.2 billion annually in charity care, community benefits and unreimbursed government programs. Together with our patients, physicians, partners, and communities, we are creating a more just, equitable, and innovative healthcare delivery system.


Pay Range
$45.26 - $74.67 /hour

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