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Software Engineer - Medical Device Product Development

Fusion Life Sciences

Newark, DE • On-site

Contractor

Re-posted 7 days ago

Job description

 
Job:Software Engineer – Medical Device Product Development
Location: Newark, DE (Hybrid)
 
Experience: 7+ years
 
Industry Preference: Medical Devices / Regulated Healthcare Products / Embedded or Product Software
Role Summary:
We are seeking a Software Engineer with strong product development experience to support development and maintenance of software systems used in medical device platforms.
The role involves designing, developing, debugging, and maintaining software for both existing and next-generation medical device products, while ensuring compliance with quality and regulatory requirements.The ideal candidate will have experience working in cross-functional engineering environments, supporting the full product software lifecycle from design through
testing and release.
Key Responsibilities:
Product Software Development Design, develop, and maintain software for medical device products and platforms.
Implement new product features and support enhancement of existing systems.
Develop software aligned with product design and system architecture.
Agile Development Work within Agile / Scrum development environments.
Support continuous integration and automated build pipelines.
 
Testing & Debugging
Identify, troubleshoot, and resolve complex software issues.
Support development of software test plans and collaborate with test engineers.
Design Documentation
Create and maintain software requirements, design documentation, and technical specifications.
Ensure documentation supports regulatory and internal compliance requirements.
Cross-Functional Collaboration
Work closely with Design Assurance, Regulatory Affairs, Clinical Affairs, and Quality teams.
Support engineering changes and product improvements.

Product Lifecycle Support
Contribute to development of new products and improvements to existing systems.
Participate in product roadmap discussions and technical design reviews.
Technical Leadership
Provide technical guidance and mentorship to junior engineers.
Support adoption of engineering best practices and quality standards.
Required Qualifications:
5+ years of software development experience in product development environments.
Strong programming skills in C++, C#, .NET, or similar object-oriented languages.
Experience with software architecture, algorithms, and data structures.
Experience debugging and troubleshooting complex systems.
Familiarity with version control systems (Git, SVN, Azure DevOps, etc.).
Strong understanding of software development lifecycle.