Process Development Engineer
Job Posting for Process Development Engineer at IT Minds LLC
Position: Process Development Engineer Medical Devices
Duration: Long-Term
Location: Providence, RI (On-site)
Job Description
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
Duration: Long-Term
Location: Providence, RI (On-site)
Job Description
- The key to the job is a process development engineer within med device. He would look at other industries but really wants med device. He said they could be pharma but they would have to be on the fill and finish side not the cell or chemistry side.
- GMP experience within Med Device.
- Experience with documentation within process development (SOP's, process dev reports)
- Experience with labeling development and processes.
- Able to work out on the manufacturing floor and troubleshooting.
- If they are able to work on a 3D CAD tool that would be a huge plus (They are using SolidWorks).
- A Mechanical engineering degree is preferred but not a must.
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.
- 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 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.
- 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.
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