Vertex
Medical Device
ProductLifecycleEngineeringPrincipalScientistMedicalDevice&CombinationProducts
“Product Lifecycle Engineering Principal Scientist - Medical Device & Combination Products at Vertex. Skills: Product lifecycle engineering, Combination products, Drug delivery systems, Risk management. Lead sustaining engineering activities for commercialized medical devices. Maintain and update design history documentation”
Industry & Context.
Problem-solving; Technical issue resolution; Root cause analysis
Occasional travel
What They're Looking For.
Must Have
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Engineering, or related scientific/engineering discipline, Minimum of 10 years of experience working within a regulated medical device, drug delivery, and combination product environment, knowledge of design controls and risk management for regulated products, Demonstrated experience in sustaining engineering, product lifecycle management, or post-market design assurance in collaboration with cross-functional product support from Quality, Regulatory, and Manufacturing teams, Working knowledge of process engineering and manufacturing methods, analytical methods, labeling and packaging, and systems engineering, technical writing, problem-solving, and communication skills, Ability to manage multiple priorities and work effectively across teams, Experience supporting change assessments and design updates in a structured quality system
Nice to Have
Experience with product development of combination products, specifically drug delivery systems, Experience with design controls and risk management as it pertains to FDA, EU MDR, and associated harmonized standards (ISO 13485, ISO 14971, 21CFR. 820 and 21CFR Part 4) and a thorough understanding of GxP principles and practices, Experience leading technical teams and projects in highly matrixed environments
What You'll Do.
Lead sustaining engineering activities for commercialized medical devices
Maintain and update design history documentation
Maintain engineering records
Maintain lifecycle deliverables
Ensure risk management documentation is current
Align risk documentation with post-market product changes
Align risk documentation with investigations
Align risk documentation with commercialization needs
Support engineering assessments related to design changes
Support engineering assessments related to component updates
Support engineering assessments related to supplier changes
Support engineering assessments related to product improvements
Assess product impact with Quality Assurance
Assess product impact with Regulatory Affairs
Assess product impact with Process Development
Assess product impact with Analytical
Assess product impact with Labeling
Assess product impact with Manufacturing
Implement lifecycle changes effectively
Evaluate technical issues arising during commercialization
Evaluate technical issues arising during post-market support
Drive timely resolution of technical issues
Provide engineering input to change control
Provide engineering input to deviation investigations
Provide engineering input to CAPA
Provide engineering input to nonconformance activities
Support continued compliance with design control
Support continued compliance with risk management
Support continued compliance with medical device requirements
Support continued compliance with combination product requirements
Contribute to product robustness
Contribute to product reliability
Contribute to product manufacturability
Make data-driven engineering decisions
Participate in cross-functional reviews
Ensure product lifecycle activities are documented
Ensure product lifecycle activities are executed
Identify opportunities for continuous improvement in sustaining engineering
Identify opportunities for continuous improvement in documentation practices
Identify opportunities for continuous improvement in cross-functional workflows
Serve as technical resource for lifecycle management activities
Support Regulatory activities
Author regulatory submission documentation
How You'll Work.
Team & Collaboration
Cross-functional teams; Quality Assurance; Regulatory Affairs; Process Development; Analytical; Manufacturing; Labeling
Communication Scope
Technical writing; Communication skills
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