Process Development Engineer

Job Role: Process Development Engineer

Location: Bridgewater, NJ

Contract: W2

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 Protocols, Reports, SOPs, and Work Instructions, as required, and conducts or coordinates testing and execution of identified activities.

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

 Design 3D CAD models, create drawings, and collaborate with vendors to produce prototypes 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.

 Performs other duties as assigned.

Required Qualifications:

 BS or MS in engineering or another relevant discipline.

 5+ years of experience (3+ 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.

 Ability to coach and train less experienced engineers.

 Understanding cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21 CFR820 is a plus. Knowledge of global cGMP requirements governing device or combination products.

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

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

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