Supira Medical a clinical-stage Shifamed Portfolio Company is developing a low-profile high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical please visit .
ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh Shifamed LLC is a privately held medical device innovationhub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description:
We are currently looking for a hands-on Director Software Engineering interested in developing a medical device in a fast-paced startup this role you will oversee embedded software architecture direct security strategy (in partnership with third-party consultants) and drive excellence in software development planning and process. You will collaborate closely with clinical hardware quality regulatory affairs and engineering teams to deliver high-integrity compliant and secure solutions that meet both regulatory requirements and clinical needs. This is a full time on-site position and will require reporting to our offices located in Los Gatos CA.
Responsibilities Skills & Hands-On Experience: - Manage internal and external software development.
- Provide direct software development contribution.
- Develop budgets and project plans.
- Develop design specifications based on top-level product requirements.
- Develop and implement software compliance policies and procedures including with respect to IEC 62304 FDA guidance HIPAA cybersecurity and GDPR requirements.
- Experience managing medical device software development from concept through regulatory approval.
- Experience managing multiple simultaneous development projects with geographically diverse teams.
- Familiarity in full stack development with C and Qt for medical device applications.
- Working knowledge/experience with cloud security and security certifications
- Familiarity with user management authentication and authorization frameworks.
- Strong verbal and written communications and presentation skills.
- Preferred: Experience with development of GUIs used in a clinical setting.
- Experience with Software as a medical device
- Preferred: Experience with development of real-time embedded controls for a medical device.
Education & Work Experience: - BS in CE CS or a related discipline.
- Minimum 12 years of relevant experience including 5 years of technical management responsibilities with medical device technologies.
- Proficiency in programming using C C and Python and experience with OOP design.
- Proven project management experience on large software projects with hardware components and real time systems
- Experience with a class III medical device company.
- Experience in a venture-funded startup environment.
- Preferred: Advanced degree in an engineering discipline.
Our salary ranges are calculated by role level and location. Please note that your position within that range will be determined by your job-related knowledge location skills experience relevant education and training/certifications. The base salary range for this full-time position is between $210000 - $240000 equity benefits.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to
| Required Experience:
Director
Supira Medical a clinical-stage Shifamed Portfolio Company is developing a low-profile high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffe...
Supira Medical a clinical-stage Shifamed Portfolio Company is developing a low-profile high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical please visit .
ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh Shifamed LLC is a privately held medical device innovationhub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description:
We are currently looking for a hands-on Director Software Engineering interested in developing a medical device in a fast-paced startup this role you will oversee embedded software architecture direct security strategy (in partnership with third-party consultants) and drive excellence in software development planning and process. You will collaborate closely with clinical hardware quality regulatory affairs and engineering teams to deliver high-integrity compliant and secure solutions that meet both regulatory requirements and clinical needs. This is a full time on-site position and will require reporting to our offices located in Los Gatos CA.
Responsibilities Skills & Hands-On Experience: - Manage internal and external software development.
- Provide direct software development contribution.
- Develop budgets and project plans.
- Develop design specifications based on top-level product requirements.
- Develop and implement software compliance policies and procedures including with respect to IEC 62304 FDA guidance HIPAA cybersecurity and GDPR requirements.
- Experience managing medical device software development from concept through regulatory approval.
- Experience managing multiple simultaneous development projects with geographically diverse teams.
- Familiarity in full stack development with C and Qt for medical device applications.
- Working knowledge/experience with cloud security and security certifications
- Familiarity with user management authentication and authorization frameworks.
- Strong verbal and written communications and presentation skills.
- Preferred: Experience with development of GUIs used in a clinical setting.
- Experience with Software as a medical device
- Preferred: Experience with development of real-time embedded controls for a medical device.
Education & Work Experience: - BS in CE CS or a related discipline.
- Minimum 12 years of relevant experience including 5 years of technical management responsibilities with medical device technologies.
- Proficiency in programming using C C and Python and experience with OOP design.
- Proven project management experience on large software projects with hardware components and real time systems
- Experience with a class III medical device company.
- Experience in a venture-funded startup environment.
- Preferred: Advanced degree in an engineering discipline.
Our salary ranges are calculated by role level and location. Please note that your position within that range will be determined by your job-related knowledge location skills experience relevant education and training/certifications. The base salary range for this full-time position is between $210000 - $240000 equity benefits.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to
| Required Experience:
Director
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