Product Development Engineering Senior Scientist

Job Description

JOB TITLE: Product Development Engineering Senior Scientist

LOCATION: 225A Carolina Ave, Providence, RI 02905

OPENINGS:1

DUTIES:Product development and design transfer of implantable cell encapsulation devices for delivering proprietary cells. Support compilation and maintenance of Design History File(s), ensuring compliance with all internal and external processes, procedures, and standards. With cross-functional input, lead Design Control and Risk Management documentation. Lead Design Inputs by collecting User Requirements and translating them into Functional Requirements as appropriate. Correlate Design Inputs with Design Outputs and support Design Verification and Validation Studies. Support translation of R&D specifications into Design documentation; displays an eye for completeness, ensuring enough detail is captured for Process Development and Manufacturing purposes and aligned with User Requirements, Functional Requirements, and Design Inputs as appropriate. Lead Design Reviews, ensuring compliance with internal procedures and external standards, and logs minutes and follow-up in the Design History File as appropriate. Manage Change Control, works with Cross-Functional Team for Impact Assessment, and manage timely completion of activities while ensuring updates are made to relevant documents in the Design History File. Support the technical aspects of New Product Commercialization by effectively utilizing product knowledge and first-generation learnings to inform the efficient Design and Development of subsequent product generations.

REQUIREMENTS:Bachelor's degree in Engineering or another relevant discipline. or related field and five (5) years of experience in the job offered or in a Product Development Engineering Senior Scientist-related occupation.

Position requires demonstrable experience in the following:

• Working within a regulated medical device environment.

• Process scale-up: including determination of cost of goods for manufacturing, management of contract manufacturers, development and validation of cleaning and assembly processes, equipment qualification, and optimization of in-process test methods.

• Product development: including design controls, risk analysis and Failure Mode and Effect Analysis (FMEA).

• Technology transfer.

• Process transfer: Including cleanroom packaging and process development and validation and test method development.

• Manufacturing oversight.

• Statistical analysis and process optimization.

• Manufacturing process and material flow.

• Contributing to manufacturing sections within regulatory filings.

• CAD 3D modeling and drawings.

• Root Cause Investigations, CAPA's and change control.

• cGxP principles and practices, ISO 13485, ISO 14971, 21CFR.820.

CONTACT:Send Resume to Sarah Hadjian at sarah_hadjian@vrtx.com. Reference 12140.422. EOE.

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