Product Development Engineering Senior Scientist - Medical Device & Combination Products

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.
• Translate User Requirements into Design Requirements as appropriate.
• Correlate Design Inputs with Design Outputs and support Design Verification and Validation Studies (as needed) to be executed both internally and externally.
• Lead 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 Quality System Documentation.
• Display an eye for completeness, ensuring enough detail is captured for Process Development and Manufacturing purposes.
• Align with User Requirements, Functional Requirements, and Design Inputs as appropriate.
• Must be familiar and adhere to C.T.Q. flow down.

• 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 development and characterization 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 work streams in highly matrixed environments.
• Experience with medical device and drug delivery packaging development, container closure integrity testing and mechanical performance testing.
• A thorough 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.
• Must be able to work independently with adequate supervision, multi‑task and support several projects simultaneously.
• Must demonstrate strong interpersonal and teamwork skills.

• 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.
• May require occasional travel to other Vertex locations.

$126,600 - $189,800. The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job‑related factors permitted by law.

On‑Site Designated 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.

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 A