Brooksource is hiring: Manufacturing Engineer in Santa Clara

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This range is provided by Brooksource. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$65.00/hr - $75.00/hr

Senior Manufacturing Engineer

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.
• 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.
• 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).
• Support the transfer of product lines and the qualification-validation efforts.
• Evaluate manufacturing equipment for IT/OT readiness, including network connectivity, data acquisition capabilities, and integration with MES/ERP systems.
• Lead efforts to ensure equipment compliance with cybersecurity standards and data integrity requirements (e.g., 21 CFR Part 11, ISA/IEC 62443).
• Collaborate with cross-functional teams to implement smart manufacturing technologies and support digital transformation initiatives.
• Conduct equipment assessments to support predictive maintenance, real-time monitoring, and lifecycle management strategies.
• Develop and maintain technical documentation for equipment integration, validation (IQ/OQ/PQ), and system compatibility.
• 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, Industrial, Electrical, or Systems Engineering; Master’s degree preferred.
• 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.
• Experience with MES, ERP and/or PLM systems
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDR and other applicable regulations.
• Familiarity with cybersecurity standards for manufacturing environments (e.g., ISA/IEC 62443).
• Proficiency in data analysis tools (e.g., Minitab, Python, SQL) and CAD software (e.g., SolidWorks).
• Experience with implementing Lean, Six Sigma and 5S concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus.
• Excellent communication and project management skills.
• Ability to work independently and collaboratively in a fast-paced, evolving environment.
• 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  IT Services and IT Consulting and Medical Equipment Manufacturing

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Medical insurance

Vision insurance

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