Process Development Engineer | Medical Device/Pharma
2 weeks ago
Job DescriptionJob Description
Process Development Engineer | Cranston, RI
General Summary:
This role will focus on the development of implantable 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 Cranston, RI and requires 100% onsite presence.
Key Responsibilities:
Design and development of equipment, processes, and control systems, used for production and assembly of 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.
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, MS or recent PhD graduates in Polymer Science, Polymer Engineering, Chemistry or Chemical Engineering or another relevant discipline.
5+ years of experience (3+ years with Masters, 0+ years with PhD) working on process development and optimization within a medical device environment or other GMP-regulated industry.
Experiences in free-radical crosslinking chemistry, thin film coating or coating onto hydrophilic/ hydrophobic surfaces and in-process control characterization using analytical tools are highly desired and preferred.
An understanding of statistical principles and strong technical writing and presentation skills is required.
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.
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 is preferred.
Hands-on approach to problem-solving, risk identification, and resolution. Six-sigma Green Belt / DMAIC problem-solving experience preferred.
2+ years of experience with polymer chemistry, chemical processing, batch process scale-up, material characterization, polymer structure-property-performance relationships, or relevant experience are highly desired and preferred.
Experience leading and managing new process development initiatives from concept through execution, including process documentation and process qualification is preferred.
Ability to coach and train less experienced engineers.
Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.
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