Sr. Manufacturing Engineer (Sustaining)

About the Role

Channel Medsystems is a privately held, commercial-stage company dedicated to transforming women’s healthcare through the development and commercialization of its flagship product, the Cerene® Cryotherapy Device. Cerene provides gynecologists with an innovative solution for treating women suffering from heavy menstrual bleeding (HMB) and dysmenorrhea. The ideal candidate is an experienced mechanical engineer who has supported the launch of an innovative medical device and successfully led efforts to reduce product costs and improve gross margin.

This position ensures post-market product reliability, quality, and cost-effectiveness by troubleshooting manufacturing issues, leading continuous improvement projects, managing validation processes, reducing costs, and ensuring regulatory compliance (FDA/ISO) through cross-functional teamwork with Quality, R&D, Supply Chain, and the Contract Manufacturing Organization (CMO). Additionally, the role involves working with the CMO to analyze manufacturing data, improve yields, update manufacturing/validation documentation, and implement corrective actions (CAPAs) for the manufacturing line.

Responsibilities

• Collaborate with Manufacturing Engineering and R&D to develop new equipment and process modifications for the manufacturing line.
• Analyze, troubleshoot, and optimize existing manufacturing processes for better yield, quality, and efficiency (Lean, Six Sigma).
• Use appropriate statistical tools to monitor and characterize the performance of the manufacturing line (control charts, process capability, etc.) and collaborate with Contract Manufacturer(s) to monitor and improve output and yield.
• Recommend Design for Manufacturability (DFM) guidance to R&D Engineering to initiate new product designs and process improvements.
• Lead product failure investigations (8D, FMEA) using effective root cause analysis tools to implement effective corrective/preventive actions (CAPAs).
• Support complaint investigations, health hazard evaluations, field actions, IFU and labeling changes, and regulatory assessments of design changes.
• Identify and implement cost-saving opportunities without sacrificing quality.
• Participate in cross-functional engineering teams to troubleshoot device and manufacturing issues and implement resulting improvements.
• Train product assemblers, inspectors, technicians, and engineers to effectively perform device assembly and inspection operations.

Requirements

• BS degree in engineering, science, or other technical discipline.
• 5+ years’ experience in product and technology development and manufacturing in medical devices.
• Strong technical writing skills with the ability to document manufacturing processes, validation protocols/reports, and other technical information.
• Strong interpersonal skills and collaboration with internal stakeholders and external suppliers.
• Experience working directly with external manufacturers in the execution of manufacturing transfers and manufacturing improvement projects.

Qualifications

• Competency using common engineering management, design, and analysis tools (e.g., SolidWorks or similar tools for 3D modeling and design, Minitab/Excel for manufacturing data analysis and control, MS Project or similar for project management).
• Working knowledge of finite element analysis, tolerance analysis, and geometric tolerancing.
• Awareness and working knowledge of component- and assembly-level constraints with engineering materials (mechanical, electrical; polymers/metals/etc.).
• Ability to coordinate work in multiple projects simultaneously.
• Work independently and develop ideas and solutions to known product challenges.
• Working knowledge of medical terminology.
• Experience in a regulated medical device industry using the QSR, ISO/EN, and Quality System Standards; awareness of and experience applying Good Manufacturing Practices (GMP) in a manufacturing environment.
• Experience and results in technology development in a production and/or product manufacturing position in the medical device (or similar) field.
• Must be able to work in the US.