Job Description

Job Description

Reporting to the Associate Director of Product Development Engineering, this role will focus on the development of novel combination products incorporating devices and novel cell and gene therapies. The successful candidate will join the Product Development 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

• Lead and manage design controls and risk management activities for a novel cell-based combination product.
• Collaborate with highly cross-functional team to develop and document product development and risk management activities.
• Lead compilation and maintenance of Design History File(s), ensuring compliance with all internal and external processes, procedures, and standards.
• Support setting of design specifications, including design inputs, user requirements, functional requirements, and design outputs.
• Contribute to design verification and validation program activities and ensure activities are adequately documented in the design files.
• Own the organization’s requirements managements tools and ensure cross-functional training and utilization of the platform.
• Support device-system associated studies including packaging, sterilization, and human factors.
• Drive cross-functional engagement with drug substance teams to ensure essential requirements are being communicated with device teams accordingly.
• Perform design reviews and stage gate reviews through the product development life cycle.
• Author regulatory submission documentation relative to devices and combination products.
• Manage and develop group of product development engineers.

Experience:

• Deep knowledge of product development in medical devices, and combination products including drug/device and/or biologic/device.
• Extensive knowledge of risk management per ISO 14971 and risk analyses and methods, including DFMEA’s, PFMEA’s, and URRA’s.
• Extensive experience with Design Controls as it pertains to ISO 13485, EU MDR, and FDA 21 CFR 820.
• Thorough understanding of c.G.x.P principles and practices.
• Proven experience bringing devices and therapies through development and commercialization.
• Familiarity cellular therapies, implantable devices, and surgical systems a plus.
• Experience with project and product management principles and a track record of delivering results on time while mitigating risks.

Required Qualifications:

• B.S or M.S in engineering or another relevant discipline.
• Minimum of 10 years of experience working within a regulated medical device environment.
• Minimum of 5 years of experience managing technical team(s) with 3+ direct reports.
• Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously.
• Must demonstrate strong interpersonal and teamwork skills.

Flex Designation:

Flex Eligibility Status:

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 ApplicationAssistance@vrtx.com