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Channel Medsystems · 4 hours ago

Sustaining Manufacturing Engineer

Santa Rosa, CA

Full-time

Onsite

Senior Level

5+ years exp

Channel Medsystems is a privately held company focused on transforming women’s healthcare with its Cerene® Cryotherapy Device. The Sustaining Manufacturing Engineer role is responsible for ensuring product reliability and quality, troubleshooting production issues, and leading continuous improvement projects in collaboration with cross-functional teams.

BiotechnologyHealth CareMedical DeviceWomen's

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 production 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) and 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 production issues and implement resulting improvements

Train product assemblers, inspectors, technicians, and engineers to effectively perform device assembly and inspection operations

Qualification

Medical device experienceLean Six SigmaTechnical writingSolidWorksMinitabFinite element analysisQuality System StandardsProject managementInterpersonal skillsCollaborationProblem-solvingIndependent work

Required

BS degree in engineering, science or other technical discipline

5+ years' experience in product and technology development 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

Competency using common engineering management, design, and analysis tools (e.g. SolidWorks or similar tool for 3D modeling and design, Minitab/Excel for production data analysis and control, MS Project or similar for project management, etc.)

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

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 production environment

Experience and results in technology development in a production and/or product manufacturing position in the medical device (or similar) field