Description

Job Description

General Summary:

In June 2019, Vertex announced the establishment of new research sites in Boston and Providence where research, development, and clinical manufacturing for cell 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 of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy, and Type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex's continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (V.C.G.T.), our research teams will bring together the best biology, technologies, and enhanced manufacturing capabilities, to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

Reporting to the Product Development Engineer Manager, this role will focus on the development of an immunoprotective device for a novel cell therapy intended to treat patients with Type 1 diabetes, as well as the development of a surgical system for device implantation. The successful candidate will join a highly visible team and work closely with Clinical Development, Process Development, Research Engineering, Quality Control, Quality Assurance, Analytical Development, Regulatory Affairs, Supply Chain, and Manufacturing Functions, as required. The position will be on-site in Providence, R.I.

Key Duties and Responsibilities:

Collaborate with a highly cross-functional team to manage design control and risk management activities for a unique stem cell-based combination product.

Support Human Factors Engineering program through planning and reporting of usability studies with end users, such as surgeons and hospital staff.

Support medical device and combination product packaging development activities, including shipping and distribution testing of temperature-controlled systems, shelf-life testing, and designing for ISO-5 cleanroom compatibility.

Translate learnings from First-in-Human clinical trials to support design and development activities for scale-up and commercialization.

Support next-gen sterilization activities, including vendor selection and onboarding, process development, sterilization validations, and product impact assessments.

Define design specifications, including design inputs, user requirements, functional requirements, and design outputs.

Support Design Verification and Design Validation activities and studies.

Review and update 2D drawings to improve functionality and manufacturability of device constituents. Perform tolerance stack-up analysis of assemblies as required.

Knowledge and Skills:

Experience with development of medical devices or combination products is required. Knowledge of surgical systems, such as orthopedics, hernia repair, vascular surgery, etc. is a plus.

Experience with ownership and authorship of Design History Files, leading Design Control and Risk Management initiatives is required, including FMEAs and Traceability Matrices. Must be able to present to Cross-Functional Team for input, revision, and closure.

A thorough understanding of cGxP principles and practices (ISO 13485, ISO 14971, and 21C.F.R.820) is required.

Experience or comfort with simulated-use testing in cadaveric or animal models is a plus.

Experience with a 3D CAD software, such as SolidWorks is a plus.

Strong technical writing and presentation skills are required. Working knowledge of statistical principles is advantageous.

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

Must demonstrate strong interpersonal and teamwork skills.

Education and Experience:

B.S or M.S in mechanical engineering, biomedical engineering, or another relevant discipline.

Typically requires 3-5 years of experience working within a regulated medical device environment.

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 atApplicationAssistance@vrtx.com.