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Manufacturing Engineer (Endoscope)

Company: a Biotechnology/Medical Devices company located in
Location: San Francisco
Posted on: January 16, 2022

Job Description:

Senior Manufacturing Engineer (Endoscope)

Taking ownership of key internal and contract cystoscope manufacturing processes.
Driving quality, delivery, and cost improvements in manufacturing (including reviews of current capabilities and establishing new processes).
Partnering with the R&D to develop and transfer new products, designs, and processes into production, driving adherence to DFM (Design for Manufacturing).
Working with and managing manufacturing partner to optimize and validate the scope assembly processes, with a focus on increasing scope durability and reliability.
Partnering with Quality to analyze scope failures, determine root cause and identify corrective actions.
Working with R&D to develop our next-generation scope technology, ensuring the design is reliable, cost effective, and designed for manufacturability.
Managing external vendors to develop optimized components and assembly processes, identify and resolve issues and qualify new products. This may involve visits and teleconferences with domestic and overseas partners.
Leading engineering support to manufacturing and resolve issues impacting production fulfillment (e.g. troubleshoot existing manufacturing processes, fixtures, tooling or equipment).
Initiating, taking ownership, and completing technical projects leading to new or improved products or processes, for current programs, and next generation programs.
Designing and developing processes to optimize efficient process flow, reduce process or product variability, improve process capability, and improve employee safety.
Providing engineering support to outside suppliers and contract manufacturers, ensuring quality and production targets are met.
Working closely with R&D to develop new manufacturing processes and ensure those processes are robust, cost efficient and ready for high volume production.
Creating process validation protocols, conduct process optimization studies, conduct process verifications and validations, and generate verification and validation reports.
Performing process capability assessments and establish methods to control process output.
Developing, verifying, and validating products from process development to successful commercialization.
Writing and performing IQ's, OQ's and PQ's when introducing new or changing existing manufacturing equipment.
Training, developing, and/or providing work direction to operators and technicians.
Preparing well written and technically correct product development design control documentation.
Researching and recommending new technologies to improve reliability, efficiency and contribute to cost reduction.
Communicating business and technical needs, status, results, and observations to operating, technical and business teams.
Responsible for process documentation and ensuring it is kept current like Manufacturing Instructions, Standard works documents, PFMEA, standard works and Control Plans.
Maintaining trained status for, and comply with, all relevant aspects of the company's Quality Management System to ensure product and support regulatory compliance.
Understanding and adhering to the company's Quality and EHS policies.
Traveling up to 20% (domestic and international).

Minimum of five years' experience in an engineering capacity
Extensive experience supporting endoscope medical device manufacturing.
Experience in leading highly technical projects in a cross functional environment both internally and with CMOs/Vendors.
Extensive experience with root cause analysis and problem solving for both technical and process issues.
Preferred experience with Lean and Six Sigma tools.
Basic working knowledge of CAD (SolidWorks or other) software.
Excellent computer skills with specific skills in Microsoft Office and proficient in SolidWorks.
Experience working in a structured design process such as ISO9000 or FDA QSR, knowledge of regulatory approval process and requirements.
Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001 and EN46001.

B.S. in Mechanical / Electrical Engineering or related engineering discipline

Keywords: a Biotechnology/Medical Devices company located in, San Francisco , Manufacturing Engineer (Endoscope), Engineering , San Francisco, California

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