Shifamed
Akura Medical a Shifamed Portfolio Company is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900000 Americans resulting in about 100000 premature deaths. To learn more about Akura Medical please visit .
About Shifamed Founded in 2009 by serial entrepreneur Amr Salahieh Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description Our Principal Quality Engineer will establish quality practices and drive quality and compliance in design and development in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the process design and development in early a key member of the team you will create quality practices to current regulations and standards and drive all aspects of design control. This position also represents an opportunity to influence the design selection optimization specifications and test development and enable patient safety quality and reliability in medical device software. This position will play an active role in developing quality management system and ensure QMS compliance adherence.
Responsibilities, Skills & Hands-On Experience
Develop and implement software quality plans procedures and policies to ensure adherence to quality standards.
Establish quality standards in procedures and work environments (i.e. bug tickets threat modeling cybersecurity).
Drive design controls deliverables including but not limited to DHF software requirements specifications design / software verification and validation documentation and risk management documentation.
Develop risk management files and associated deliverables such as FMEA and security risk management.
Develop QMS infrastructure and processes per FDA Quality System Regulations and ISO 13485 and ensure compliance to these regulations.
Prepare technical documentation including but not limited to software design requirements test methods protocols and reports to support design control activities and regulatory submissions.
Provide guidance on applicable standards and regulations and enable implementation of those into designs.
Review design control documentation including but not limited to requirements specifications test methods protocols and reports.
Develop quality inspection methods and processes in manufacturing and design.
Qualify and maintain the suppliers per the supplier management process.
Lead Nonconforming Materials Report (NCMR) investigation and identify appropriate corrective actions.
Identify the need for Corrective Action Preventative Action (CAPA). Initiate implement and close CAPAs.
Provide support and lead sections of audits by outside agencies.
Education & Work Experience
B.S. or higher in Biomedical Electrical or Software (CQE preferred).
10 years in quality engineering within the medical device industry including electromechanical products and SaMD / SiMD.
Strong knowledge of Design Controls Risk Management and Software Verification & Validation.
Proficient in ISO 13485 FDA QSR EU MDR and software lifecycle standards (ISO 62304).
Experience with supplier quality CAPA nonconforming materials and process improvement.
Exposure to human factors usability engineering labeling and electronics reliability.
Ability to travel to support project objectives
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 $170000 - $200000 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.
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About Shifamed Founded in 2009 by serial entrepreneur Amr Salahieh Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description Our Principal Quality Engineer will establish quality practices and drive quality and compliance in design and development in a collaborative way. This position represents an exciting opportunity to join an innovative and high performing team and influence the process design and development in early a key member of the team you will create quality practices to current regulations and standards and drive all aspects of design control. This position also represents an opportunity to influence the design selection optimization specifications and test development and enable patient safety quality and reliability in medical device software. This position will play an active role in developing quality management system and ensure QMS compliance adherence.
Responsibilities, Skills & Hands-On Experience
Develop and implement software quality plans procedures and policies to ensure adherence to quality standards.
Establish quality standards in procedures and work environments (i.e. bug tickets threat modeling cybersecurity).
Drive design controls deliverables including but not limited to DHF software requirements specifications design / software verification and validation documentation and risk management documentation.
Develop risk management files and associated deliverables such as FMEA and security risk management.
Develop QMS infrastructure and processes per FDA Quality System Regulations and ISO 13485 and ensure compliance to these regulations.
Prepare technical documentation including but not limited to software design requirements test methods protocols and reports to support design control activities and regulatory submissions.
Provide guidance on applicable standards and regulations and enable implementation of those into designs.
Review design control documentation including but not limited to requirements specifications test methods protocols and reports.
Develop quality inspection methods and processes in manufacturing and design.
Qualify and maintain the suppliers per the supplier management process.
Lead Nonconforming Materials Report (NCMR) investigation and identify appropriate corrective actions.
Identify the need for Corrective Action Preventative Action (CAPA). Initiate implement and close CAPAs.
Provide support and lead sections of audits by outside agencies.
Education & Work Experience
B.S. or higher in Biomedical Electrical or Software (CQE preferred).
10 years in quality engineering within the medical device industry including electromechanical products and SaMD / SiMD.
Strong knowledge of Design Controls Risk Management and Software Verification & Validation.
Proficient in ISO 13485 FDA QSR EU MDR and software lifecycle standards (ISO 62304).
Experience with supplier quality CAPA nonconforming materials and process improvement.
Exposure to human factors usability engineering labeling and electronics reliability.
Ability to travel to support project objectives
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 $170000 - $200000 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.
#J-18808-Ljbffr