Insulet Corporation
Staff SW Quality Assurance Engineer (Hybrid)
Insulet Corporation, Oklahoma City, Oklahoma, United States
Overview
Staff SW Quality Assurance Engineer (Hybrid) — Insulet Corporation This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of the quality system. This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices including supporting the Cyber security development processes and Cyber Bill of Materials. This role will interface with other Insulet departments (e.g. Research and Development, IT-Cybersecurity, Sustaining, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and software used for automation of the quality system.
Job Title:
Staff SW Design Quality Assurance Engineer Department:
Design Quality Assurance FLSA Status:
Exempt
Responsibilities
Lead Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, mobile applications, cloud-based systems, and cybersecurity.
Ensure compliance to IEC 62304 and FDA Guidance on Software Contained in a 510(k) Submission.
Support cybersecurity risk management for US and ROW requirements.
Support development teams on the validation of software tools.
Provide guidance for the generation, review, and approval of design control documentation with primary focus on software development deliverables.
Collaborate with Project Management to support the Design Control process and Continuous Improvement initiatives to optimize SW Development processes.
Serve as the Design Control expert to the software development organization.
Develop and deliver Design Control training for the software development organization.
Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation.
Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation and provide timely feedback.
Support creation of necessary documentation to comply with regulatory requirements and industry best practices.
Support execution of Risk Management Activities for complex systems in compliance with ISO14971 and software risk requirements in IEC 62304.
Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and IEC 62304.
Provide guidance on, and participate in, software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management.
Apply a working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements related to QA in software development; communicate with project software engineers to ensure complete documentation (user needs, requirements, plans, verification and validation, risk assessments, etc.).
Education And Experience
BS degree in computer science, computer engineering or equivalent field; Master’s degree preferred.
Experience with medical device software development; cloud software in medical devices preferred.
Experience with a risk-based approach to validate COTS software and SW tools.
Experience with software mobile applications, cloud-based systems, and cybersecurity.
Minimum 8 years of work experience in Software Quality Engineering within FDA/ISO or other regulated environment or equivalent combination of education and experience.
Experience in developing and implementing effective Design Control Systems.
Working knowledge of QSR (FDA 21 CFR Part 820) and ISO 13485; familiarity with IEC 62304, ISO 14971, IEC 62366, IEC 60601 and FDA software guidance.
Familiarity with software development tools (configuration management, issue/defect tracking, requirements analysis, etc.).
Experience with software development lifecycles with emphasis on software quality engineering aspects.
Skills/Competencies
Effective verbal and written communication skills.
Ability to collaborate with individuals at multiple levels in an organization.
Ability to prioritize and manage critical project timelines in a fast-paced environment; handle multiple responsibilities concurrently.
Strong analytical and problem-solving skills.
Ability to work effectively in a high-stress, high-energy environment.
Ability to influence people and projects in a fast-moving environment.
ASQ CSQE or other software quality certificates are beneficial.
Note This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office; may work remotely other days).
Additional Information The US base salary range for this full-time position is $104,325.00 - $156,487.50. Salaries are determined by role, level, and location. Individual pay within the range is influenced by location and factors including skills, experience, and training. Your Talent Acquisition Specialist can share more about the specific salary range for your location during the hiring process. Compensation details reflect base salary and do not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD) is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For more information, please visit insulet.com and omnipod.com.
#J-18808-Ljbffr
Staff SW Quality Assurance Engineer (Hybrid) — Insulet Corporation This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of the quality system. This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices including supporting the Cyber security development processes and Cyber Bill of Materials. This role will interface with other Insulet departments (e.g. Research and Development, IT-Cybersecurity, Sustaining, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and software used for automation of the quality system.
Job Title:
Staff SW Design Quality Assurance Engineer Department:
Design Quality Assurance FLSA Status:
Exempt
Responsibilities
Lead Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, mobile applications, cloud-based systems, and cybersecurity.
Ensure compliance to IEC 62304 and FDA Guidance on Software Contained in a 510(k) Submission.
Support cybersecurity risk management for US and ROW requirements.
Support development teams on the validation of software tools.
Provide guidance for the generation, review, and approval of design control documentation with primary focus on software development deliverables.
Collaborate with Project Management to support the Design Control process and Continuous Improvement initiatives to optimize SW Development processes.
Serve as the Design Control expert to the software development organization.
Develop and deliver Design Control training for the software development organization.
Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation.
Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation and provide timely feedback.
Support creation of necessary documentation to comply with regulatory requirements and industry best practices.
Support execution of Risk Management Activities for complex systems in compliance with ISO14971 and software risk requirements in IEC 62304.
Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and IEC 62304.
Provide guidance on, and participate in, software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management.
Apply a working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements related to QA in software development; communicate with project software engineers to ensure complete documentation (user needs, requirements, plans, verification and validation, risk assessments, etc.).
Education And Experience
BS degree in computer science, computer engineering or equivalent field; Master’s degree preferred.
Experience with medical device software development; cloud software in medical devices preferred.
Experience with a risk-based approach to validate COTS software and SW tools.
Experience with software mobile applications, cloud-based systems, and cybersecurity.
Minimum 8 years of work experience in Software Quality Engineering within FDA/ISO or other regulated environment or equivalent combination of education and experience.
Experience in developing and implementing effective Design Control Systems.
Working knowledge of QSR (FDA 21 CFR Part 820) and ISO 13485; familiarity with IEC 62304, ISO 14971, IEC 62366, IEC 60601 and FDA software guidance.
Familiarity with software development tools (configuration management, issue/defect tracking, requirements analysis, etc.).
Experience with software development lifecycles with emphasis on software quality engineering aspects.
Skills/Competencies
Effective verbal and written communication skills.
Ability to collaborate with individuals at multiple levels in an organization.
Ability to prioritize and manage critical project timelines in a fast-paced environment; handle multiple responsibilities concurrently.
Strong analytical and problem-solving skills.
Ability to work effectively in a high-stress, high-energy environment.
Ability to influence people and projects in a fast-moving environment.
ASQ CSQE or other software quality certificates are beneficial.
Note This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office; may work remotely other days).
Additional Information The US base salary range for this full-time position is $104,325.00 - $156,487.50. Salaries are determined by role, level, and location. Individual pay within the range is influenced by location and factors including skills, experience, and training. Your Talent Acquisition Specialist can share more about the specific salary range for your location during the hiring process. Compensation details reflect base salary and do not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD) is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
For more information, please visit insulet.com and omnipod.com.
#J-18808-Ljbffr