Job Description

General Summary:

The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems.  The Product Development Engineering 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. 
• 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 Quality System Documentation. 
• Display an eye for completeness, ensuring enough detail is captured for Process Development and Manufacturing purposes. Aligns with User Requirements, Functional Requirements, and Design Inputs as appropriate.  

Knowledge and Skills:

• Proven experience with Medical Device Development including ownership and/or authorship of Design and Development file records and Risk Management deliverables. 
• Experience with medical device packaging development and mechanical performance testing is preferred.
• Working knowledge of Test Methods for selection, verification and validation of components, sub-systems and assemblies. 
• Able to present to cross-functional team for input, alignment, and design and risk file updates. 
• Must have experience executing workstreams in highly matrixed environments.
• A strong understanding of cGxP principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820. 
• A strong understanding of statistical principles is required, as are strong technical writing and presentation skills. 

Education and Experience:

• Degree in Engineering preferred but will consider other related disciplines
• PhD with 0-3 years of experience, M.S with 3+ years, or B.S with 4+ years of experience.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]