https:/wayup.com/sitemap.xml
Principal Systems Engineer
https:/wayup.com/sitemap.xml, Boston, Massachusetts, us, 02298
Job DescriptionWarwick Consulting specializes in providing comprehensive medical device solutions, focusing on areas like non-compliance remediation, software assurance, and cybersecurity. Their expertise also covers Software as a Medical Device (SaMD), verification and validation (V&V), and research and development (R&D) services. Established in 2011, the firm has helped clients in over 25 therapeutic areas and facilitated the commercialization of more than 35 medical devices. We are seeking a Principal Systems Engineer to join our team and contribute to several high-tech, high-visibility projects.
Principal Systems Engineer (1+ Year Contract)
Position Overview:
Reporting to the Systems Engineer Consultant, you will be responsible for collaborating with the client's digital ecosystem to align user needs and business objectives with customer and stakeholder requirements. This role demands a deep understanding of the product lifecycle, requirements management, and software development processes, particularly in the context of Software as a Medical Device (SaMD) or Software as a Service (SaaS) products.
Key Responsibilities:
User and Stakeholder Requirements Translation: Work closely with users and business units to translate needs and inputs into well-defined customer and stakeholder requirements.
Product Lifecycle Documentation: Analyze use cases, document the product lifecycle, and define usage conditions for the product.
Software Requirements Development: Develop detailed Software Requirement Specifications (SRS) and ensure that implementation and test coverage are adequate to meet these requirements.
Design History File (DHF) Management: Build and manage all elements of the DHF to ensure compliance with industry standards.
Design Control Process Expertise: Apply a strong working knowledge of the design control process throughout the software development lifecycle.
Verification & Validation (V&V): Collaborate or lead efforts to develop and execute verification and validation activities to ensure product integrity.
Product Development Process (PDP) Expertise: Drive product development through all life cycle stages, ensuring compliance and functionality at each phase.
Standards and Compliance Knowledge: Leverage a strong understanding of IEC 62304 and other relevant ISO standards to guide development.
Clinical Validation and Usability: Understand clinical validation requirements, including usability and human factors testing.
Requirements Management: Utilize tools such as JAMA, Cockpit, DOORS, or equivalent platforms for requirements tracking and management.
Cross-Functional Collaboration: Work across multiple departments to align on deliverables and objectives, ensuring cohesive progress.
Bug Management and Change Control: Support, track and manage product issues and changes throughout the lifecycle.
CI/CD Pipeline: Familiarity with continuous integration and delivery practices, particularly in a medical software context.
Leadership and Communication: Present project progress and key milestones to senior leadership and wider audiences.
Qualifications:
Proven experience in systems engineering, particularly in medical device software development.
Strong understanding of the software development life cycle (SDLC), product development processes, and design controls.
Hands-on experience with requirements management tools and V&V activities.
Knowledge of IEC 62304, ISO standards, and regulatory compliance within the medical device sector.
Excellent communication and presentation skills, with the ability to engage cross-functional teams and leadership.
Minimum 5 years of experience required for this role.
#J-18808-Ljbffr
Principal Systems Engineer (1+ Year Contract)
Position Overview:
Reporting to the Systems Engineer Consultant, you will be responsible for collaborating with the client's digital ecosystem to align user needs and business objectives with customer and stakeholder requirements. This role demands a deep understanding of the product lifecycle, requirements management, and software development processes, particularly in the context of Software as a Medical Device (SaMD) or Software as a Service (SaaS) products.
Key Responsibilities:
User and Stakeholder Requirements Translation: Work closely with users and business units to translate needs and inputs into well-defined customer and stakeholder requirements.
Product Lifecycle Documentation: Analyze use cases, document the product lifecycle, and define usage conditions for the product.
Software Requirements Development: Develop detailed Software Requirement Specifications (SRS) and ensure that implementation and test coverage are adequate to meet these requirements.
Design History File (DHF) Management: Build and manage all elements of the DHF to ensure compliance with industry standards.
Design Control Process Expertise: Apply a strong working knowledge of the design control process throughout the software development lifecycle.
Verification & Validation (V&V): Collaborate or lead efforts to develop and execute verification and validation activities to ensure product integrity.
Product Development Process (PDP) Expertise: Drive product development through all life cycle stages, ensuring compliance and functionality at each phase.
Standards and Compliance Knowledge: Leverage a strong understanding of IEC 62304 and other relevant ISO standards to guide development.
Clinical Validation and Usability: Understand clinical validation requirements, including usability and human factors testing.
Requirements Management: Utilize tools such as JAMA, Cockpit, DOORS, or equivalent platforms for requirements tracking and management.
Cross-Functional Collaboration: Work across multiple departments to align on deliverables and objectives, ensuring cohesive progress.
Bug Management and Change Control: Support, track and manage product issues and changes throughout the lifecycle.
CI/CD Pipeline: Familiarity with continuous integration and delivery practices, particularly in a medical software context.
Leadership and Communication: Present project progress and key milestones to senior leadership and wider audiences.
Qualifications:
Proven experience in systems engineering, particularly in medical device software development.
Strong understanding of the software development life cycle (SDLC), product development processes, and design controls.
Hands-on experience with requirements management tools and V&V activities.
Knowledge of IEC 62304, ISO standards, and regulatory compliance within the medical device sector.
Excellent communication and presentation skills, with the ability to engage cross-functional teams and leadership.
Minimum 5 years of experience required for this role.
#J-18808-Ljbffr