Senior Process Engineer – Medical Device
AM Technical Solutions- Who Are We:
AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.
Senior Process Engineer Medical Device
AM is looking for a Senior Process Engineer with Medical Device experience to join our organization to supportthe 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.
Direct Involvement Opportunities:
- 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, SOPs 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.