Sustaining Manufacturing Engineer - Santa Rosa - CERENE cryotherapy device by Channel Medsystems

Description

Sustaining Manufacturing Engineer

Location: Santa Rosa, CA

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 Class 3, FDA-approved procedure requires no capital equipment and can be performed in the convenience of a gynecologist's office without general anesthesia or operating-room resources. The Company is committed to advancing cryotherapy as a new standard of care to provide women a modern alternative to invasive surgery or long-term medications for the treatment of heavy menstrual bleeding.

This position ensures post-market product reliability, quality, and cost-effectiveness by troubleshooting production 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, working with the CMO to analyze manufacturing data, improve yields, update manufacturing/validation documentation and implement corrective actions (CAPAs) for the production line.

JOB DUTIES AND 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

ESSENTIAL REQUIREMENTS:

• 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

Please respond to:

• Resume
• Salary requirements
• Recent examples highlighting your experience and qualifications

Agency and Third-Party Recruiter Notice:

Agencies that submit a resume to Channel Medsystems must have a current Agreement executed by the company. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by Channel Medsystems.

Channel Medsystems is an equal opportunity employer and consistent with federal, state, and local requirements. Channel Medsystems will consider requests for reasonable accommodation based on disability or sincerely held religious beliefs where it can do so without undue hardship for the company. Channel Medsystems is proud to be an Equal Opportunity Employer inclusive of disability and veterans.