Product Development Engineering Scientist

Job Overview The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems, working closely with cross‑functional teams across Research and Development, Device Quality Control, Device Quality Assurance, Process Development, Clinical/Commercial Packaging & Labeling, Regulatory Affairs, and Manufacturing Functions. Key Responsibilities Author design history documentation for 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 (internally and externally). Manage change control, deviations and non‑conformances with cross‑functional teams for impact assessment and investigations, and ensure timely completion of activities while updating relevant documents in the design history file. Perform design history file maintenance, including review and revision of all design and quality system documentation. Ensure completeness, capturing sufficient detail for process development and manufacturing purposes. Align with user requirements, functional requirements, and design inputs. 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. Ability to present to cross‑functional teams for input, alignment, and design and risk file updates. Experience executing workstreams in highly matrixed environments. Strong understanding of cGxP principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820. Strong understanding of statistical principles, technical writing and presentation skills. Education and Experience B.S. or M.S. in engineering or another relevant discipline. At least 2 years of experience working within a medical device environment. Pay Range $105,600 – $158,400. Benefits Medical, dental and vision benefits. Paid time off, including a week‑long company shutdown in the summer and winter. Educational assistance programs, including student loan repayment. Generous commuting subsidy. Matching charitable donations. 401(k) plan. Flex Designation On‑site designated role: 5 days per week on site with ad‑hoc flexibility. Equal Employment Opportunity 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 View email address on click.appcast.io. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)