Manufacturing Engineer
2 weeks ago
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.
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