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Job description

Process Development Engineer

Providence, RI

100% Onsite

12+ Months Contract to Start

General Summary: This role will 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. The position is based out of Providence, RI.

Key Responsibilities:

• Design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices.
• Manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies.
• Support ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability.
• Establishes operating specifications, defines process windows, and improves manufacturing techniques/processes.
• Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• 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.
• Support Deviation Management, CAPA, and Change Control activities, as required.

Required Qualifications:

• BS or MS in engineering or another relevant discipline.
• 8+ years of experience (5+ years with Masters) working on process development and optimization within a medical device environment or other GMP regulated industry.
• Experience leading and managing new process development initiatives from concept through execution, including process documentation and process qualification.
• 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.
• Hands-on approach to problem solving, risk identification and resolution. Six-sigma Green Belt / DMAIC problem solving experience preferred.

Job Type: Contract

Salary: $70.00 - $90.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• Providence, RI 02905: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Medical devices Or Pharma: 1 year (Required)

Work Location: In person

Speak with the employer
+91 (978) 966-1607