Engineer, Process Engineering

Job Description

Job Description

Job Description:
Strong understanding of medical device manufacturing process development, transfer, optimization, and validation (IQ/OQ/PQ).
Demonstrated experience supporting both internally developed and externally sourced manufacturing processes within regulated environments.
Solid foundation in statistical methods and data-driven problem solving, including DOE, process characterization, process capability analysis, and root cause investigation.
Proficient in use of Minitab, or similar statistical software.
Working knowledge of risk management and design control methodologies, including FMEA, control plans, and design transfer activities.
Experience with complex medical device manufacturing processes such as catheter assembly, balloon processing, laser processing, extrusion, thermal forming/heat setting, bonding, precision assembly, and/or injection molding preferred.
Familiarity with electro-mechanical and capital equipment manufacturing processes preferred.
Ability to troubleshoot complex manufacturing and process-related issues and implement effective corrective and preventive actions.
Ability to read, understand, and create engineering drawings using common engineering software, including GD&T interpretation for tight-tolerance components.
Ability to conduct complex statistical, geometric, and mathematical calculations.
Ability to conduct responsibilities substantially free from routine supervision.
Demonstrated commitment to patient safety, product quality, and compliance with applicable quality systems and regulatory requirements.
Ability to adopt and defend technical positions in an open and collaborative environment.
Demonstrated project and task management skills across multiple concurrent initiatives.
Strong technical communication skills, including the ability to write and review protocols, reports, specifications, and technical documentation.

Comments for Suppliers:
This job will be located in Waltham, MA and it's a fully onsite role.
180 Third Avenue
Suite 500
Waltham, MA 02451