Product Development Engineering Senior Scientist - Medical Device & Combination Products

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, asrequired.

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 asappropriate. Correlates Design Inputs with Design Outputs and supportsDesignVerification 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 managetimelycompletion of activities while ensuring updates are made to relevant documents in Design History File.

• Perform Design History File maintenance asrequired, 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 asappropriate. Must be familiar and adhere to C.T.Q. flow down.

Knowledge and Skills:

• Proven experience with Medical Device and Combination Product Development including ownership and authorship of Design and Development file records and leading Risk Management initiatives.

• Working knowledge of developmentand characterization of Test Methods forselection, verification and validation of components, sub-systemsand 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.

• Experience with medical device and drug delivery packaging development, container closure integrity testing and mechanical performance testing.

• A thorough understanding ofcGxPprinciples and practices, ISO 13485, ISO 14971, and 21C.F.R.820.

• A strong understanding of statistical principles isrequired, as are strong technical writing and presentation skills.

• Must be able to work independently with adequate supervision, multi-taskand support several projects simultaneously.

• Mustdemonstratestrong interpersonal and teamwork skills.

Education and Experience:

• PhD with 2+ years of experience, M.S with 5+ years, or B.S with 8+ years of experience.

• Degree in Engineering preferred but will consider other related disciplines. Experience developing drug delivery systems is strongly preferred.

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 ApplicationAssistance@vrtx.com