Manufacturing Engineer (Endoscope)
Company: a Biotechnology/Medical Devices company located in
Location: San Francisco
Posted on: January 16, 2022
Senior Manufacturing Engineer (Endoscope)
Taking ownership of key internal and contract cystoscope
Driving quality, delivery, and cost improvements in manufacturing
(including reviews of current capabilities and establishing new
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
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
Traveling up to 20% (domestic and international).
Minimum of five years' experience in an engineering capacity
Extensive experience supporting endoscope medical device
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
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
Keywords: a Biotechnology/Medical Devices company located in, San Francisco , Manufacturing Engineer (Endoscope), Engineering , San Francisco, California
Didn't find what you're looking for? Search again!