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Now viewing: Senior Project Manager - Medical Device #3064
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Enhanced Compliance Inc.
Senior Project Manager - Medical Device #3064
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Job Description
About the
This individual will work directly with internal cross-functional teams and SFMD supplier partners to align deliverables, dependencies, risks, documentation, and execution plans. The contractor will partner with Software Engineering, Manufacturing Engineering, Quality, Regulatory Affairs, Supplier Quality, Supply Chain, Operations, Cybersecurity, IT, and external supplier organizations to ensure software activities are completed in accordance with applicable medical device quality system requirements and software lifecycle standards. The successful candidate must bring strong project management discipline, hands-on Jira proficiency, Agile/Scrum operating experience, and practical experience delivering software projects in regulated medical device environments. What You'll Do Lead planning and execution of the Non-Product Software workstream across Manufacturing Software and SFMD software activities to support product integration and new product development efforts.
Develop and maintain integrated project plans, milestone schedules, and project risks, and release plans.
Prepare concise status updates, leadership summaries, decision logs, and escalation materials for risk and issue resolution.
Coordinate internal and supplier-facing activities across software, manufacturing, quality, regulatory, operations, cybersecurity, IT, and supply chain stakeholders.
Coordinate requirements, design inputs, validation planning, test evidence, release readiness, deployment planning, and production support handoffs.
Partner with Manufacturing Engineering, Operations, Quality, Regulatory, and R D to ensure internal software solutions meet business, production, and compliance needs.
Facilitate alignment between supplier deliverables and internal expectations for design controls, change control, validation, cybersecurity, risk management, and regulatory readiness.
Identify, track, and escalate dependencies between internal manufacturing systems, supplier-owned software solutions, product configuration, software distribution, and production release activities.
Ensure software project activities are planned and executed in alignment with regulated medical device software lifecycle expectations.
Support software planning, requirements management, verification, validation, traceability, risk management, change management, and release processes.
Facilitate design reviews, validation readiness reviews, risk reviews, defect triage, and audit-readiness discussions.
Track objective evidence and documentation deliverables required for software release, manufacturing implementation, medical device man...
Role:
The ideal candidate will manage Manufacturing Software and Sourced Finished Medical Device software-related workstreams within a medical device integration program. The role will support internal manufacturing software, supplier-managed software activities, software distribution, validation, release planning, production readiness, and transition-to-sustainment activities.This individual will work directly with internal cross-functional teams and SFMD supplier partners to align deliverables, dependencies, risks, documentation, and execution plans. The contractor will partner with Software Engineering, Manufacturing Engineering, Quality, Regulatory Affairs, Supplier Quality, Supply Chain, Operations, Cybersecurity, IT, and external supplier organizations to ensure software activities are completed in accordance with applicable medical device quality system requirements and software lifecycle standards. The successful candidate must bring strong project management discipline, hands-on Jira proficiency, Agile/Scrum operating experience, and practical experience delivering software projects in regulated medical device environments. What You'll Do Lead planning and execution of the Non-Product Software workstream across Manufacturing Software and SFMD software activities to support product integration and new product development efforts.
Develop and maintain integrated project plans, milestone schedules, and project risks, and release plans.
Prepare concise status updates, leadership summaries, decision logs, and escalation materials for risk and issue resolution.
Coordinate internal and supplier-facing activities across software, manufacturing, quality, regulatory, operations, cybersecurity, IT, and supply chain stakeholders.
Coordinate requirements, design inputs, validation planning, test evidence, release readiness, deployment planning, and production support handoffs.
Partner with Manufacturing Engineering, Operations, Quality, Regulatory, and R D to ensure internal software solutions meet business, production, and compliance needs.
Facilitate alignment between supplier deliverables and internal expectations for design controls, change control, validation, cybersecurity, risk management, and regulatory readiness.
Identify, track, and escalate dependencies between internal manufacturing systems, supplier-owned software solutions, product configuration, software distribution, and production release activities.
Ensure software project activities are planned and executed in alignment with regulated medical device software lifecycle expectations.
Support software planning, requirements management, verification, validation, traceability, risk management, change management, and release processes.
Facilitate design reviews, validation readiness reviews, risk reviews, defect triage, and audit-readiness discussions.
Track objective evidence and documentation deliverables required for software release, manufacturing implementation, medical device man...