Senior Development Engineer, Combination Product

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.

This role will focus on the design and development of drug-device and biologic‑device combination products. The successful candidate will work closely with Process Development, Quality Assurance, Regulatory Affairs, Clinical Development, Analytical, and Manufacturing functions, as required. The position will be located in Providence, RI or Boston, MA.

Key Responsibilities

• Collaborate with highly cross‑functional teams to author design documentation of combination drug‑device and/or biologic device products.
• Perform compilation and maintenance of Design History File(s), ensuring compliance with all internal and external processes, procedures, and standards.
• Participate in the transfer of new technologies into process and product development, and through clinical and commercial manufacturing.
• Apply technical knowledge while supporting Human Factors Engineering to translate user requirements into functional requirements and design outputs.
• Support medical device and combination product development activities, including specification development, packaging, and other related design outputs and verification activities.
• Author Risk Analyses, including DFMEA, UFMEA, and PFMEA.
• Contribute to building, implementing, and maintaining business systems for product requirements, quality system elements, and risk management activity to support the design and development process.

Experience:

• Must have experience with product development of combination products, specifically drug delivery systems.
• Must have experience with design controls and risk management as it pertains to FDA, EU MDR, and associated harmonized standards (ISO 13485 and ISO 14971).

Required Qualifications:

• B.S or M.S in engineering or another relevant discipline.
• Minimum of 5 - 10 years of experience working within a regulated medical device environment.
• Proven experience with Medical Device Product Development, Design History Files, Device Risk Management and Lifecycle Management.
• A thorough understanding of cGxP principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.
• Strong technical writing and presentation skills.
• Must be able to work independently with adequate supervision, multi‑task and support several projects simultaneously.

Contract Length: 6 months with the chance to extend.

$75/hr.

- $92.00/hr.

Monday - Friday