Software Quality Engineer / Quality Management - Medical Device
Software Quality Engineer / Quality Management - Medical DeviceStart:
ASAPLocation:
Work can be 100% remoteProject Type:
Contract (W-2 Only)Project Length:
6 months to startPay:
$55.
00 - $70.
00 per hour +/- (depending on experience) This role can be 100% remote.
If candidate is local to Indianola PA, would be hybrid.
DEPARTMENT/TEAM DESCRIPTIONRadiology Software Assurance & Operations TeamPrimary Function:
o Software Quality Management of Radiology device products to meet FDA design controls and other regulatory bodieso Software Quality Management of GxP relevant computer systemsPOSITION SUMMARYThis position will be responsible to perform software quality management activities of medical devices (Class-2) to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls and other regulatory bodies.
POSITION DUTIES & RESPONSIBILITIESActivitieso Software Quality Management of Software in Medical Device (SiMD) of Class-2 and Class-1 medical devices, including Application software, Embedded software, Platform software, Operating system softwareo Software Quality Management of Software as a Medical Device (SaMD) of Class-2 and Class-1 medical devices, including Application software, AI/ML software, Platform software including IaaS and PaaS, Cloud based softwareo Responsible for ensuring development initiatives of Bayer Radiology medical devices complies and adheres to regulatory standards and guidance such as FDA Design Controls CFR 820.
30, IEC 62304- Software in a Medical Device, IEC 82304- Software as a Medical Device, IEC 14971- Risk Management, ISO 13485- Quality Management Systems, 2017/745- European Union Medical Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, General Principles of Software Validation, Off The Shelf (OTS a.
k.
a SOUP) software use, Software as a Medical Device:
Clinical Evaluationo Conducts evaluation of software engineering activities of medical device development including requirements, software risk analysis, design, development, documentation, integration, verification, validation and release to deliver medical devices that are safe, secure and effectiveo Reviews all the deliverables of medical device software lifecycle and provide clear, concise, and timely feedback to stakeholderso Responsible for ensuring computer system validation initiatives in Bayer Radiology organization complies and adheres to standards and guidance such as General Principles of Software Validation, Computer Software Assurance for Production and Quality System Software, FDA CFR Part 11 Complianceo Provides guidance to cross functional teams to ensure software quality objectives are met for medical device software developmento Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function such as Software Problem Resolution meetings and documentation, CAPA actions, Process and template updates and Audit supportREQUIREMENTS / PREFERENCESSkill & Competency Requirements:
o Bachelors degree in Computer Engineering, Electronics, or Electrical Engineeringo Minimum of 7 years of relevant work experience in software engineering or quality engineering in medical device developmento Minimum of 2 years of relevant work experience in software quality management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD)o Minimum of 2 years or more of experience in interpreting industry standards for medical device development and updating processes and procedureso Quality Management System - ISO 13485o SiMD - IEC 62304o SaMD - IEC 82304o FDA 21 CFR 820.
30o 2017/745 - European Union Medical Device Regulation (EU MDR)o Minimum of 2 years or more of experience in applying industry standards for medical device development as followso General Principles of Software Validationo FDA CFR Part 11 Complianceo Must be able to handle multiple tasks/projects and manage priorities accordingly.
o Technical writing ability - clear and concise writing easily understood by multiple audiences (auditors, peers, etc.
)o Ability to work in-office and remotePreferences:
o Familiarity with AI/ML based medical device software quality managemento 2 or more years of relevant work experience in various phases of software development lifecycle including requirements, architecture, design, development, testing, release, deployment, post-launch support activitieso 2 or more years of programming experience in any of the following languages C, C#, Java, React JS, Angularo Working knowledge of tools including JIRA, AWS, GitHub, Rational Quality Manager, DOORS Next Geno Working knowledge on OS such as Windows, Linux flavorso Demonstrated ability working in a matrix/hybrid organization structureo Ability to troubleshoot and make quick knowledge and experience-guided decisionso Excellent written and oral communicationo Excellent people skills, ability to partner well, good team camaraderieo Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management toolsPay Details:
$55.
00 to $70.
00 PER HOUR Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan.
Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.
In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https:
//www.
pdstech.
com/candidate-privacy />The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
Recommended Skills Angular4 Architecture Artificial Intelligence Auditing Business Process Improvement C Sharp (Programming Language) Estimated Salary: $20 to $28 per hour based on qualifications.
ASAPLocation:
Work can be 100% remoteProject Type:
Contract (W-2 Only)Project Length:
6 months to startPay:
$55.
00 - $70.
00 per hour +/- (depending on experience) This role can be 100% remote.
If candidate is local to Indianola PA, would be hybrid.
DEPARTMENT/TEAM DESCRIPTIONRadiology Software Assurance & Operations TeamPrimary Function:
o Software Quality Management of Radiology device products to meet FDA design controls and other regulatory bodieso Software Quality Management of GxP relevant computer systemsPOSITION SUMMARYThis position will be responsible to perform software quality management activities of medical devices (Class-2) to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls and other regulatory bodies.
POSITION DUTIES & RESPONSIBILITIESActivitieso Software Quality Management of Software in Medical Device (SiMD) of Class-2 and Class-1 medical devices, including Application software, Embedded software, Platform software, Operating system softwareo Software Quality Management of Software as a Medical Device (SaMD) of Class-2 and Class-1 medical devices, including Application software, AI/ML software, Platform software including IaaS and PaaS, Cloud based softwareo Responsible for ensuring development initiatives of Bayer Radiology medical devices complies and adheres to regulatory standards and guidance such as FDA Design Controls CFR 820.
30, IEC 62304- Software in a Medical Device, IEC 82304- Software as a Medical Device, IEC 14971- Risk Management, ISO 13485- Quality Management Systems, 2017/745- European Union Medical Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, General Principles of Software Validation, Off The Shelf (OTS a.
k.
a SOUP) software use, Software as a Medical Device:
Clinical Evaluationo Conducts evaluation of software engineering activities of medical device development including requirements, software risk analysis, design, development, documentation, integration, verification, validation and release to deliver medical devices that are safe, secure and effectiveo Reviews all the deliverables of medical device software lifecycle and provide clear, concise, and timely feedback to stakeholderso Responsible for ensuring computer system validation initiatives in Bayer Radiology organization complies and adheres to standards and guidance such as General Principles of Software Validation, Computer Software Assurance for Production and Quality System Software, FDA CFR Part 11 Complianceo Provides guidance to cross functional teams to ensure software quality objectives are met for medical device software developmento Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function such as Software Problem Resolution meetings and documentation, CAPA actions, Process and template updates and Audit supportREQUIREMENTS / PREFERENCESSkill & Competency Requirements:
o Bachelors degree in Computer Engineering, Electronics, or Electrical Engineeringo Minimum of 7 years of relevant work experience in software engineering or quality engineering in medical device developmento Minimum of 2 years of relevant work experience in software quality management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD)o Minimum of 2 years or more of experience in interpreting industry standards for medical device development and updating processes and procedureso Quality Management System - ISO 13485o SiMD - IEC 62304o SaMD - IEC 82304o FDA 21 CFR 820.
30o 2017/745 - European Union Medical Device Regulation (EU MDR)o Minimum of 2 years or more of experience in applying industry standards for medical device development as followso General Principles of Software Validationo FDA CFR Part 11 Complianceo Must be able to handle multiple tasks/projects and manage priorities accordingly.
o Technical writing ability - clear and concise writing easily understood by multiple audiences (auditors, peers, etc.
)o Ability to work in-office and remotePreferences:
o Familiarity with AI/ML based medical device software quality managemento 2 or more years of relevant work experience in various phases of software development lifecycle including requirements, architecture, design, development, testing, release, deployment, post-launch support activitieso 2 or more years of programming experience in any of the following languages C, C#, Java, React JS, Angularo Working knowledge of tools including JIRA, AWS, GitHub, Rational Quality Manager, DOORS Next Geno Working knowledge on OS such as Windows, Linux flavorso Demonstrated ability working in a matrix/hybrid organization structureo Ability to troubleshoot and make quick knowledge and experience-guided decisionso Excellent written and oral communicationo Excellent people skills, ability to partner well, good team camaraderieo Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management toolsPay Details:
$55.
00 to $70.
00 PER HOUR Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan.
Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.
In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https:
//www.
pdstech.
com/candidate-privacy />The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
Recommended Skills Angular4 Architecture Artificial Intelligence Auditing Business Process Improvement C Sharp (Programming Language) Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
