Manufacturing Engineer

Med Device Industry

Onsite 5 days a week in Santa Clara

6 Month+ Contract with change to convert full time

Position Overview

The Senior Manufacturing Engineer is responsible for designing, developing, testing, validating, and implementing processes, tooling, and fixtures for on-market products. The Senior Manufacturing Engineer will work closely with integration teams and serve as a core member of the team through successful implementation into the company's manufacturing operations.

Essential Job Functions

• Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
• Support and work with Quality to address and resolve non-conformances, CAPA and/or audit findings identified by internal or external sources
• Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
• Perform tolerance analysis for components, manufacturing materials, packaging, and supplies used for in-house processing.
• Lead effort to develop and maintains process Failure Modes and Effects Analyses (pFMEAs) for company processes.
• Prepare user requirements, technical specifications, and design specifications.
• Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process development and manufacturing efforts.
• Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI's, LHR's), and other Quality System requirements.
• Support efforts to integrate new systems into the production environment.
• Evaluate existing engineering processes and implements process improvements.
• Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
• Lead and/or actively participates in process/product improvement projects (in cooperation with production, Quality engineers and technicians).
• Identify opportunities and implement cost reduction plans for existing products.
• Support the transfer of product lines and the qualification-validation efforts.
• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

Requirements

• Bachelor's degree in Mechanical/Biomedical/Industrial Engineering or equivalent experience
• Minimum of five (5) years of experience in a medical device environment or equivalent experience in other industries (pharmaceutical or automotive) that use the same principles of operation and similar regulations, or 3 years of experience with a Master's Degree.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDR and other applicable regulations.
• Experience with implementing Lean, Six Sigma and 5S concepts.
• Experience with MES, ERP and/or PLM systems is a plus
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.
• Ability to use special software such as: Solidworks, Minitab or closely related.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Employee may be required to occasionally lift objects up to 25 lbs.