Software MedTech

Job Title:

Technical/Functional Skills:

Must have skills

Desired Competencies (Technical/Behavioral Competency)

1. Hands-On experience of acting as a primary subject matter expert in the field of Medical Device FW Architecture, Modeling, Design and Development
2. Lead delivery of safety critical embedded Systems and application software for Medical Devices.
3. Experience in architecture, modeling, requirements definition, development, developing requirements and specifications, project planning, execution, management, and documentation to ensure compliance to SDLC, policies and procedures.
4. Excellent Knowledge of Medical Device Design Control Requirements for regulatory compliance
5. Expertise in Windows development environments, software architectures, security and communication protocols: (Bluetooth, Wifi) and programming languages: (C, C++, C# a plus), Frameworks/APIs, device drivers, Methodologies: OOD, Data Modeling Principals, Standards: (FDA 21 CFR 820, IEC 62304)
6. Cybersecurity experience desired
7. Extensive experience in both Waterfall and Agile (Agile preferred)
8. Knowledge of Quality System Regulation (21 CFR 820) & Quality Management System (ISO 13485:2016), IEC 62304
9. Knowledge of EU Medical Device Regulation (MDR)
10. Knowledge of Regulatory documents (510(k), PMA, Technical File)
11. Good Analytical and problem-solving skills
12. Excellent written and oral communication skills

Desirable

1. Project management experience
2. Ability to work under pressure and to strict deadlines
3. Knowledge of regulations beyond US and EU.

Education

1. A Bachelor’s/Masters Degree (Biomedical /Electronics/Computer Science) from an accredited college or university is required

Responsibility of / Expectations from the Role

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1. Plan, develop, coordinate, and manage development for large Medical engineering project or a number of small projects with many complex features
2. Define SW requirements from high level product requirements and track them to closure
3. Respond to RFxs
4. Define SW Architectures
5. Assess the feasibility and soundness of proposed SW solution
6. Identify training needs

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