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    Product Development Engineering Scientist - Providence, United States - Vertex Pharmaceuticals

    Vertex Pharmaceuticals
    Vertex Pharmaceuticals Providence, United States

    3 weeks ago

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    Description
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    locations

    Providence, RI

    time type

    Full time

    posted on

    Posted 2 Days Ago

    job requisition id

    REQ-21583

    Job Description

    This role will report to the senior manager of Product Development and focus on the design and transfer of implantable cell encapsulation devices for delivering proprietary cells.

    The successful candidate will join the Process Engineering Team and work closely with Research and Development, Device Quality Control, Device Quality Assurance, Regulatory Affairs, and Manufacturing Functions, as required.

    The position will be located in Providence, R.I.

    Key Responsibilities and Experience:
    Supports compilation and maintenance of Design History File(s), ensuring compliance with all internal and external processes, procedures, and standards. With cross-functional input, drafts Design Control and Risk Management documentation.
    Builds Design Inputs by collecting User Requirements and translating into Functional Requirements as appropriate. Correlates Design Inputs with Design Outputs and manages Design Verification and Validation Studies.

    Supports translation of R&D specifications into Design Documentation; displays an eye for completeness, ensuring enough detail is captured for Process Development and Manufacturing purposes.

    Prepares definitive specifications or revises – with appropriate testing – as necessary. Aligns with User Requirements, Functional Requirements, and Design Inputs as appropriate. Must be familiar and adhere to C.T.Q. flow down.
    Familiar with Risk Analyses, including d.
    F.M.E.A., u.
    F.M.E.A., and p.
    F.M.E.A. Able to present to Cross-Functional Team for input, revision, and closure. Must be familiar with U.S. F.D.A. and E.U. Risk Analysis methods and, also, those of other regulatory jurisdictions.

    Facilitates Design Reviews, ensuring compliance with internal procedures and external standards, and logs minutes and follow-up in Design History File as appropriate.

    Manages Change Control, works with Cross-Functional Team for Impact Assessment, and manages timely completion of activities while ensuring updates are made to relevant documents in Design History File.

    Supports the technical aspects of New Product Commercialization by effectively utilizing product knowledge and first-generation learnings to inform the efficient Design and Development of subsequent product generations.

    Familiarity with Root Cause Analyses relating to Process and Product Development.

    In addition, with cross-functional input, authors and executes study protocols and applicable testing regimens, and documents all Root Cause Analysis Reports.

    Performs Design History File Remediation as required, including – as applicable – review and revision of all Design and Quality System Documentation.


    Required Qualifications:
    M.S with 3+ years, or B.S with 5+ years of experience. Degree in Engineering
    Minimum of 2-5 years of experience working within a regulated medical device environment. Experience with device-biologic combination products

    Proven experience with Medical Device Product Development, ownership and authorship of Design History Files, leading Device Risk Management initiatives, and Lifecycle Management.

    Working knowledge of Process Instrumentation and Controls, development and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies.

    A thorough understanding of c.
    G.x.
    P 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.
    Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously.
    Must demonstrate strong interpersonal and teamwork skills.
    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

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    time type

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    posted on

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    Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

    The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and

    transfusion-dependent

    beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency

    .

    Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London.

    Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.

    Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For.

    For company updates and to learn more about Vertex's history of innovation, visit

    or follow us on

    Facebook

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    ,

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    ,

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    Instagram

    .

    The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths.

    By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.


    Our vision is clear:

    to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

    #J-18808-Ljbffr
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