Vertex
Biotechnology
ProductDevelopmentEngineeringSeniorScientist-MedicalDevice&CombinationProducts
Neural analysis suggests this role is
optimal for Senior candidates.
“Product Development Engineering Senior Scientist - Medical Device & Combination Products at Vertex. Skills: Combination Product Development, Drug Delivery Systems, Risk Management, Design History File. Collaborate with cross-functional teams. Author design history documentation”
Industry & Context.
Risk Management; Impact Assessment; Investigations
Occasional travel
What They're Looking For.
Must Have
2+ years PhD experience, 5+ years MS experience, 8+ years BS experience, Author Risk Analyses, Manage Change Control, Perform Design History File maintenance, Familiar with C. T. Q. flow down, Experience with Medical Device Development, Experience with Combination Product Development, Experience leading Risk Management initiatives, Experience executing workstreams in matrixed environments, Experience with medical device packaging development, Experience with drug delivery packaging development, Experience with container closure integrity testing, Experience with mechanical performance testing, Understanding of cGxP principles, Understanding of ISO 13485, Understanding of ISO 14971, Understanding of 21 C. F. R. 820, Technical writing skills, Presentation skills, Work independently with supervision, Multi-task several projects, Support several projects simultaneously, Demonstrate interpersonal skills, Demonstrate teamwork skills
Nice to Have
Degree in Engineering preferred, Experience developing drug delivery systems strongly preferred
What You'll Do.
Collaborate with cross-functional teams
Author design history documentation
Translate User Requirements
Correlate Design Inputs with Design Outputs
Support Design Verification Studies
Support Design Validation Studies
Manage Change Control
Manage Non-conformances
Conduct Investigations
Update Design History File
Maintain Design History File
Review Design Documentation
Revise Design Documentation
Review Quality System Documentation
Revise Quality System Documentation
Ensure detail for Process Development
Ensure detail for Manufacturing
Align with User Requirements
Align with Functional Requirements
Align with Design Inputs
How You'll Work.
Team & Collaboration
Cross-functional teams; Cross-functional team
Communication Scope
Presentation skills; Technical writing
Process & Methodology
Change Control, Deviations, Non-conformances
Full Job Description
**Job Description** **Job Description** In June 2019, Vertex announced the establishment of new research sites in Boston and Providence where research, development, and clinical manufacturing for cell, biologic, and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several diseases Vertex is focused on. At Vertex, our teams bring together the best talent to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. The Product Development Engineering Senior Scientist focuses on combination product development, with a particular focus on drug delivery systems. The Product Development Engineering Senior Scientist will work closely with Research and Development, Device Quality Control, Device Quality Assurance, Process Development, Clinical/Commercial Packaging & Labeling Functions, Regulatory Affairs, and Manufacturing Functions, as required. **Key Duties and Responsibilities:** * Collaborate with highly cross-functional teams to author the design history documentation of combination drug-device and/or biologic device products. * Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments. * Translates User Requirements into Design Requirements as appropriate. Correlates Design Inputs with Design Outputs and supports Design Verification and Validation Studies (as needed) to be executed both internally and externally. * Leads Design Reviews to completion, ensuring compliance with internal procedures and external standards. * Manage Change Control, Deviations and Non-conformances with Cross-Functional Team for Impact Assessment and Investigations, and manage timely completion of activities while ensuring updates are made to relevant documents in Design History File. * Perform Design History File maintenance as required, including – as applicable – review and revision of all Design and Qual
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