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Sr. Embedded Software Engineer (IVD)
156488
Posted:
12th June 2024
- 140000 USD - 170000 USD
- Menlo Park, United States
- Permanent
Senior Embedded Software Engineer Department: Engineering
Position Overview: A fast-growing medical device company specializing in In Vitro Diagnostic (IVD) solutions is seeking a Senior Embedded Software Engineer to lead the development and maintenance of embedded software for advanced diagnostic devices. This role will focus on designing new software solutions, maintaining existing codebases, ensuring regulatory compliance, and planning software lifecycle maintenance. The ideal candidate will have experience in medical software development, a strong understanding of regulatory standards, and a passion for creating high-quality, reliable solutions that meet the needs of the healthcare industry.
This role requires close collaboration with cross-functional teams, including hardware engineers, clinical scientists, and regulatory experts, to ensure successful product development and lifecycle management.
Key Responsibilities
•
Software Design & Development: Lead the architecture, design, and implementation of embedded software and applications for IVD devices in compliance with industry standards.
•
Software Maintenance: Manage existing product codebases to ensure continuous reliability, performance, and compliance with customer and regulatory requirements.
•
Lifecycle Planning: Drive software maintenance efforts, including bug fixing, updates, and performance optimization, while maintaining detailed documentation.
•
Regulatory Compliance: Ensure all development and maintenance activities adhere to relevant standards (e.g., IEC 62304, ISO 13485, FDA 21 CFR Part 820) and support regulatory submissions.
•
Collaboration: Work with cross-functional teams, including R&D, quality assurance, regulatory experts, and external contractors, to meet clinical and technical requirements.
•
Testing: Develop and execute unit tests and integration tests to ensure software meets safety and performance standards.
•
Technical Leadership: Provide mentorship to junior engineers, conduct code reviews, and promote best practices in embedded software development.
•
Process Improvement: Identify opportunities to enhance development workflows, tools, and processes to increase efficiency and product quality.
•
Project Management: Contribute to project planning, task estimation, and risk management while ensuring timely delivery of software components aligned with milestones.
Qualifications
Education:
•
Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field.
Experience:
•
6+ years of software development experience, with at least 4 years in medical devices or regulated industries (preferably IVD).
•
Strong experience with embedded systems development, RTOS, and microcontrollers.
•
Proficiency in programming languages like C, C++, and Python.
•
Proven experience maintaining and enhancing software for on-market products with a focus on reliability and compliance.
•
Familiarity with ARM-based products and development environments, such as IAR Embedded Workbench.
•
Deep knowledge of software lifecycles, including risk management and verification/validation activities in medical devices.
Skills:
•
Expertise in regulatory standards such as IEC 62304, ISO 14971, and FDA 21 CFR Part 820.
•
Strong understanding of Agile and Scrum methodologies, along with tools like Jira.
•
Excellent problem-solving abilities and communication skills, with a proven ability to collaborate with technical and non-technical stakeholders.
Preferred Qualifications
•
Experience with diagnostic devices, laboratory equipment, or healthcare technologies.
•
Familiarity with medical device cybersecurity standards (e.g., FDA cybersecurity guidance).
This role offers an exciting opportunity to work on innovative diagnostic devices, contribute to improving healthcare, and be part of a collaborative, fast-paced environment
Position Overview: A fast-growing medical device company specializing in In Vitro Diagnostic (IVD) solutions is seeking a Senior Embedded Software Engineer to lead the development and maintenance of embedded software for advanced diagnostic devices. This role will focus on designing new software solutions, maintaining existing codebases, ensuring regulatory compliance, and planning software lifecycle maintenance. The ideal candidate will have experience in medical software development, a strong understanding of regulatory standards, and a passion for creating high-quality, reliable solutions that meet the needs of the healthcare industry.
This role requires close collaboration with cross-functional teams, including hardware engineers, clinical scientists, and regulatory experts, to ensure successful product development and lifecycle management.
Key Responsibilities
•
Software Design & Development: Lead the architecture, design, and implementation of embedded software and applications for IVD devices in compliance with industry standards.
•
Software Maintenance: Manage existing product codebases to ensure continuous reliability, performance, and compliance with customer and regulatory requirements.
•
Lifecycle Planning: Drive software maintenance efforts, including bug fixing, updates, and performance optimization, while maintaining detailed documentation.
•
Regulatory Compliance: Ensure all development and maintenance activities adhere to relevant standards (e.g., IEC 62304, ISO 13485, FDA 21 CFR Part 820) and support regulatory submissions.
•
Collaboration: Work with cross-functional teams, including R&D, quality assurance, regulatory experts, and external contractors, to meet clinical and technical requirements.
•
Testing: Develop and execute unit tests and integration tests to ensure software meets safety and performance standards.
•
Technical Leadership: Provide mentorship to junior engineers, conduct code reviews, and promote best practices in embedded software development.
•
Process Improvement: Identify opportunities to enhance development workflows, tools, and processes to increase efficiency and product quality.
•
Project Management: Contribute to project planning, task estimation, and risk management while ensuring timely delivery of software components aligned with milestones.
Qualifications
Education:
•
Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field.
Experience:
•
6+ years of software development experience, with at least 4 years in medical devices or regulated industries (preferably IVD).
•
Strong experience with embedded systems development, RTOS, and microcontrollers.
•
Proficiency in programming languages like C, C++, and Python.
•
Proven experience maintaining and enhancing software for on-market products with a focus on reliability and compliance.
•
Familiarity with ARM-based products and development environments, such as IAR Embedded Workbench.
•
Deep knowledge of software lifecycles, including risk management and verification/validation activities in medical devices.
Skills:
•
Expertise in regulatory standards such as IEC 62304, ISO 14971, and FDA 21 CFR Part 820.
•
Strong understanding of Agile and Scrum methodologies, along with tools like Jira.
•
Excellent problem-solving abilities and communication skills, with a proven ability to collaborate with technical and non-technical stakeholders.
Preferred Qualifications
•
Experience with diagnostic devices, laboratory equipment, or healthcare technologies.
•
Familiarity with medical device cybersecurity standards (e.g., FDA cybersecurity guidance).
This role offers an exciting opportunity to work on innovative diagnostic devices, contribute to improving healthcare, and be part of a collaborative, fast-paced environment