Validation Engineer

Job Description

In this role you will report to the Associate Director of Process Engineering and focus on the development of implantable cell encapsulation devices for delivering proprietary cells. The successful candidate will join the Process Development Team and work on process development, optimization, process scale-up, and technology transfer of novel products and processes into Manufacturing; this position will be based out of Providence, RI.

Required Skills

BS or MS or PhD in engineering or another relevant discipline.

BS and 10 years of experience ( 8+ years with Masters, 4 years with PhD) working on process development and optimization within a medical device environment or other GMP regulated industry.

Experience leading high-complexity new process development initiatives from concept through execution, including process documentation and process qualification.

Experience acting as technical project manager and coordinating cross-functional teams to achieve desired project results.

Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21CFR820 is a plus.

Knowledge of global cGMP requirements governing device or combination products.

A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.

Basic knowledge of polymer coating , polymer processing (injection molding, roll to plate printing), and polymer joining.

Preferred Skills

Hands-on approach to problem solving, risk identification and resolution. Six-sigma Green Belt / DMAIC problem solving experience preferred.

Experience with 3D CAD software, preferably with Solidworks, is preferred.

Key Responsibilities

Design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices.

Experience with polymer joining (thermal staking, ultrasonic/ laser welding), polymer processing (injection molding, roll to plate printing), and polymer coating a plus. Identification of process technologies, developing proof of concept, prototyping, scaling up and validating for commercialization

Manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies.

Establishes operating specifications, defines process windows, and improves manufacturing techniques/processes.

Responsibilities

Responsible for writing and reporting of Protocols, Reports, SOP's, and Work Instructions, as required, and conducts or coordinates testing and execution of identified activities. Additional Responsibilities:

Statistically characterizes processes and implements controls to ensure repeatability and consistency.

Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.

Support ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability.

Design 3D CAD models, create drawings and collaborate with vendors to produce prototype and production parts. Perform engineering analyses and relevant physical testing on designs.

Provide hands-on troubleshooting, process, and manufacturing assistance in support of a rapid development cycle and manufacturing sustainability.

Execute assigned duties on time and within budget; proactively telegraph delays and other issues to relevant stakeholders.

Comply with all regulatory, corporate, and Quality System policies.

Support Deviation Management, CAPA, and Change Control activities, as required