Senior Manager, Product Development Engineering

Job Description

Reporting to the Associate Director of Product Development, this role will focus on the design, development, and complete lifecycle management of novel combination drug/device and biologic device therapies.

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 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.

As the Senior Manager - Product Development Engineering, 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 Boston, MA or Providence, RI.

Key Responsibilities

• Collaborate with highly cross-functional teams to manage and author the design history documentation of combination drug-device and/or biologic device products.

• Participate in the transfer of new technologies from research, into process and product development, and through clinical and commercial manufacturing.

• Perform compilation and maintenance of Design History File(s), ensuring compliance with all internal and external processes, procedures, and standards.

• Apply technical knowledge while working with Clinical Development and Human Factors Engineering to translate user requirements into functional requirements and design outputs.

• Drive medical device and combination product development activities, including physical design, specification development, packaging, and other related design outputs and verification activities.

• Liaison cross-functionally to support scale-up activities.

• Support Regulatory activities including authoring regulatory submission documentation.

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.

• Must have experience leading technical teams and projects including direct reports.

• Experience with medical device packaging development, including, sterile barrier design and testing. Container closure integrity testing and temperature-controlled distribution a plus.

• Experience supporting IND and NDA/BLA regulatory submissions a plus.

• Familiarity with Type 1 Diabetes (T1D) therapies or kidney related diseases a plus.

Required Qualifications:

• B.S or M.S in engineering or another relevant discipline.

• Minimum of 7-10 years of experience working within a regulated medical device environment.

• 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 engineering and manufacturing methods, development, and characterization of test methods for selection, verification and validation of components, sub-systems and assemblies.

• Experience with design validation and human factors engineering.

• Comprehensive knowledge of Design Control and Risk Management for medical devices with demonstrated experience on a variety of platforms.

• A thorough understanding of GxP principles and practices, ISO 13485, ISO 14971, 21CFR.820 and 21CFR Part 4.

• 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.

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Pay Range:

Disclosure Statement:

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 [email protected]