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Contract Medical Device Software Engineer Jobs in Ohio

... medical devices and digital health products. This role will shape system architecture, review ... contract developers to plan, integrate, and deliver mobile, cloud, and device-connected digital ...

Sr. Software Engineer

Cincinnati, OH · On-site

$117K - $155K/yr

Sr. Software Engineer At Guerbet, we build lasting relationships so that to enable people to live ... medical device development. This position involves analyzing and evaluating current software ...

Sr. Software Engineer

Cincinnati, OH · On-site

$117K - $155K/yr

Sr. Software Engineer At Guerbet, we build lasting relationships so that to enable people to live ... medical device development. This position involves analyzing and evaluating current software ...

... software-driven system Essential Skills: Ethicon Project Support Desirable Skills: Keyword: Skills: EIS : Medical Device & Regulations~EIS : Manufacturing Engineering Support

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Contract Medical Device Software Engineer information

What are some common challenges faced by Contract Medical Device Software Engineers, and how can they be addressed?

Contract Medical Device Software Engineers often encounter the challenge of rapidly adapting to new projects, technologies, and regulatory requirements unique to each client. Working within strict timelines while ensuring compliance with FDA and ISO standards can be demanding. To address these challenges, it's important to have strong communication skills, maintain thorough documentation, and stay updated on industry regulations. Collaborating closely with cross-functional teams—including quality assurance, hardware engineers, and regulatory affairs—also helps ensure project success and smooth integration into existing workflows.

What is the difference between Contract Medical Device Software Engineer vs Medical Device Software Developer?

AspectContract Medical Device Software EngineerMedical Device Software Developer
CredentialsTypically requires a degree in software engineering, biomedical engineering, or related field; certifications like ISO 13485 or FDA compliance knowledge are commonSimilar educational background; often holds certifications in medical device regulations or quality standards
Work EnvironmentContract roles in medical device companies, often project-based, with focus on compliance and validationFull-time or freelance positions within medical device firms, focusing on software development and testing
Industry UsageCommonly hired for specific projects requiring regulatory compliance and validation expertiseInvolved in ongoing software development, maintenance, and updates for medical devices

While both roles require technical expertise in medical device software, Contract Medical Device Software Engineers typically work on short-term projects with a focus on compliance and validation, whereas Medical Device Software Developers are involved in continuous software development and maintenance within the industry.

What is a Contract Medical Device Software Engineer?

A Contract Medical Device Software Engineer is a software professional who is hired on a temporary or project basis to design, develop, and test software used in medical devices. They typically work with manufacturers to ensure that the software meets regulatory standards, such as those set by the FDA or ISO. Responsibilities may include creating embedded software, documenting code, and collaborating with cross-functional teams to deliver safe and effective medical products. Their expertise is crucial for developing reliable software that supports patient safety and product compliance.

What are the key skills and qualifications needed to thrive as a Contract Medical Device Software Engineer, and why are they important?

To thrive as a Contract Medical Device Software Engineer, you need a solid background in software development (C/C++/Python), embedded systems, and knowledge of medical device regulations such as IEC 62304, typically supported by a relevant engineering degree. Familiarity with development environments, version control (e.g., Git), and tools for requirements management and verification are essential, along with any certifications in medical device software or quality systems. Strong problem-solving skills, attention to detail, and effective communication are crucial for collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to deliver safe, compliant, and innovative software solutions efficiently in a highly regulated and dynamic industry.
What are the most commonly searched types of Medical Device Software Engineer jobs in Ohio? The most popular types of Medical Device Software Engineer jobs in Ohio are:
What cities in Ohio are hiring for Contract Medical Device Software Engineer jobs? Cities in Ohio with the most Contract Medical Device Software Engineer job openings:
Electrical Engineer (Sustaining)- Medical Device

Electrical Engineer (Sustaining)- Medical Device

Techtrueup

Blue Ash, OH

Contractor

Posted 27 days ago


Job description

Company Description

Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120+ clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors. What sets us apart is our AI-powered, in-house software's enabling us to source and screen top talent within hours. This ensures rapid response times, high-quality matches, and virtually zero attrition.

Job Description

Job Title: Electrical Engineer (Sustaining)
Location:
 Blue Ash,OH / Cincinnati, OH (Onsite)
Contract Term: 12 Months
Travel Need: Occasional Travel to Mexico required
Industry - Medical Device/Aerospace/Automotive/Any Regulated Industry
Work Authorization: US Citizen, GC Holder

Job Description
The Senior Electrical Engineer will act as an electrical/electro-mechanical expert supporting and leading various engineering assignments to ensure business continuity of Capital Systems and Handheld Devices. The role involves working cross-functionally on electrical hardware and software engineering activities related to product enhancements, regulatory compliance, quality improvements, process simplification, and cost optimization. 

Key Responsibilities

  • Implement and coordinate engineering changes related to electrical hardware and software aspects of capital systems and handheld devices.
  • Lead and support field root cause investigations and resolutions, including gap analysis, production troubleshooting, and product/process validation.
  • Collaborate with cross-functional teams and suppliers to align priorities and successfully execute projects.
  • Ensure projects comply with regulatory requirements (GMP, ISO, MDR) and company policies.
  • Ensure safety and critical performance of products in accordance with medical device electrical safety standards. 

Qualifications & Education:

  • Bachelor's degree in Electrical Engineering, Computer Engineering, or related field required.
  • Advanced degree preferred. 

Required Experience:

  • Minimum 5+ years of experience in Electrical Engineering within R&D environments.
  • Experience translating customer needs into technical requirements.
  • Experience with embedded electrical design.
  • Strong electrical analysis skills and system/subsystem integration understanding.
  • Experience in root cause analysis, verification/validation testing, and creating test protocols.
  • Hands-on experience debugging electrical systems using oscilloscopes, power supplies, spectrum analyzers, etc.
  • Strong communication and leadership skills with the ability to manage projects and risks.
  • Experience working in medical device or highly regulated industries. 

Preferred Skills:

  • Knowledge of IEC 60601 medical device electrical safety standards.
  • Experience with prototype design, simulation, and testing.
  • Experience solving technical manufacturing issues.
  • Programming experience with LabVIEW, C, C++, Python, or similar languages.
  • Experience working in Agile environments. 

Other: 

  • Location: Cincinnati, OH (Blue Ash site)
  • Travel: Up to 20%
Additional Information

All your information will be kept confidential according to EEO guidelines.