Principal Quality Engineer, Medical Device Software Development Lifecycle (SDLC)

Role:Principal Quality Engineer, Medical Device Software Development Lifecycle (SDLC)
Location : West Chester, PA.
Rate: $55-60/hr on W2





Position Summary
We are seeking an experienced quality engineer to support a strategic separation project focused on harmonizing and updating software development procedures for a global Orthopedics Medical Device organization. The contractor will partner with Quality, Regulatory Affairs, Software Engineering, Product Security, Clinical, and Program Management stakeholders to support the consolidation and standardization of the Software Development Lifecycle (SDLC) framework aligned with:
IEC 62304 Medical Device Software Lifecycle Processes
FDA Quality System Regulation (21 CFR Part 820 and applicable QMSR requirements)
FDA software guidance documents
ISO 13485
ISO 14971
IEC 82304-1 (as applicable)
IEC 81001-5-1 Cybersecurity requirements
EU MDR





MDSAP requirements
Other applicable global medical device regulations and standards
The contractor will be responsible for supporting the Quality Engineering Lead by managing the quality deliverables of the program, assessing existing procedures, facilitating review of future-state processes, managing stakeholder alignment, and partnering with the technical writers to deliver an updated set of software development procedures, work instructions, templates, and implementation plans necessary to support an independent quality management system following organizational separation activities.



Key Responsibilities
Project Management
Support the workstream leaders for the Software Development Design Controls sub-stream
Coordinate with the Program Manager to track quality-related activities in the workstream project plans, timelines, deliverables, risks, and dependencies.
Coordinate activities across Software Engineering, Quality, Regulatory Affairs, Product Security, Clinical Affairs, Risk Management, and external stakeholders.
Facilitate working sessions and reporting to quality leadership.
Current-State Assessment
Assess existing software development procedures, processes, and quality system elements for alignment with higher level Product Realization Processes and Design Controls
Identify opportunities for standardization or process improvements across business units and development teams





Future-State Process Updates
In accordance with the medical device SDLC framework, partner with process owners to align procedures governing:
Software development planning
Software requirements management
Architecture and design controls
Software implementation
Unit, integration, and system testing
Software verification and validation
Defect management
Configuration management
Release management
Maintenance and sustainment
Problem resolution
Cybersecurity and secure development practices
SOUP (Software of Unknown Provenance) management
Software risk management
Agile and hybrid development methodologies within a regulated environment
Quality System Integration
Experience
Minimum 10+ years of experience in regulated medical device software development.
Demonstrated experience executing or implementing IEC 62304-compliant development processes.
Experience supporting FDA, MDSAP, EU MDR, and ISO 13485 audits.
Experience with process harmonization or separation activities.
Experience working with Class II and/or Class III medical devices.



Required Expertise
IEC 62304
FDA Software Guidance
FDA Design Controls
FDA QMSR / 21 CFR Part 820
ISO 13485
ISO 14971
EU MDR
MDSAP
Medical device cybersecurity requirements
Design Control processes
Computer System Validation principles
Software risk management