Process Engineer (Medical Devices)

Bio-pharm services company is looking for a Senior Process Engineer with Medical Device experience for a contract role expected to last 6-12 months. Role to be based near Framingham, MA. Role will support the development of implantable cell encapsulation devices for delivering proprietary cells.

Duties

• 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 implement 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; pro-actively telegraph delays and other issues to relevant stakeholders.
• Comply with all regulatory, corporate, and Quality System policies and complete other projects and/or assignments as required.
• Support Deviation Management, C.A.P.A., and Change Control activities, as required.
• Comply with all Regulatory, Corporate and Quality System policies.
• Performs other duties as assigned.

Qualifications, Skills, And Experience:

• B.S or M.S 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.
• Understanding of c.G.x.P principles and practices and familiarization with ISO 13485, ISO 14971, and 21C.F.R.820 is a plus. Knowledge of global GMP requirements governing device or combination products.
• Experience with 3D CAD software, preferably with Solidworks, is preferred.
• Experience with EtO Sterilization, sterilization validation, and familiarity with ISO 11135 is desirable.
• 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.
• 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.