Process Development Engineer

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.

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.

Requirements:

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 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.

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.

Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.

Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management.

Must demonstrate strong interpersonal, presentation, and teamwork skills.