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Channel Medsystems · 2 hours ago

Manufacturing Engineer (New Product Introduction)

Berkeley, CA

Full-time

Onsite

Mid Level

3+ years exp

Channel Medsystems is a privately held company focused on transforming women’s healthcare through innovative products like the Cerene® Cryotherapy Device. The Manufacturing Engineer will be responsible for developing, qualifying, and implementing manufacturing processes and equipment, while collaborating with various teams to ensure product quality and efficiency.

BiotechnologyHealth CareMedical DeviceWomen's

Responsibilities

Develop, qualify, transfer, and implement manufacturing processes and equipment (including semi-automated and automated assembly and inspection processes) designed to facilitate device assembly, reduce or eliminate operator dependence, and improve throughput, reliability and yield

Provide ongoing production line support and troubleshooting

Perform continuous improvement through sustaining engineering activities

Collaborate with Manufacturing Engineering and R&D to develop new equipment and process modifications for the manufacturing line

Select and qualify appropriate equipment and manufacturing fixtures used in mechanical and electrical assembly, performance testing, and inspection

Using SolidWorks or other similar 3D design software, model, fabricate, and integrate equipment and fixtures to be used in mechanical and electrical assembly, performance testing, and inspection

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

Work closely with RA, R&D, Supply Chain and Quality to identify and coordinate product and/or process change strategies and implementation requirements

Investigate and solve customer complaint issues through failure analysis and the use of statistical tools and models where appropriate

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 developmentSolidWorksStatistical analysisManufacturing processesFinite element analysisManufacturing PracticesTechnical writingCross-functional collaborationMulti-project coordinationInterpersonal skillsProject managementProblem-solving

Required

BS degree in engineering, science or other technical discipline

3+ 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

Effectively work with CMO to complete manufacturing transfers and manufacturing improvement projects

Effectively work in a cross-functional team environment

Work independently and develop ideas and solutions to known product challenges

Ability to coordinate work in multiple projects simultaneously

Competency using common engineering management, design, and analysis tools (e.g. SolidWorks or similar tools 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.)

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