Santa Clara, CA, 95054, USA
9 days ago
Process Sustaining Engineer
Job Description We are searching for a high-energy, motivated Process Sustaining Engineer to join our Life Sciences clients growing Supply Chain Engineering group. The sustaining engineer will be the focal person for technical issues in manufacturing, providing project management and technical leadership for manufacturing issues and continuous improvement efforts. The successful candidate must be highly organized with strength in mechanical, electrical, process/systems engineering, and will use this strength to help drive issue resolution, collaborating across the entire organization. Day-to-Day Responsibilities:  Lead the effort to perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements.  Track, troubleshoot, and identify the root cause for product issues escalated to engineering (NCMRs, CAPAs, NC, etc.).  Lead yield improvement, reduce product variability, and product cost reduction.  Provide engineering support for component obsolescence issues.  Provide engineering support for product compliance (IEC60601, ROHS, CE, etc.).  Change management driver across product lines.  Conduct thorough evaluations of processes using experimental design techniques and failure analysis to drive process robustness.  Participate in technical reviews and provide constructive feedback for product/process changes.  Prepare necessary documentation including, BOM, drawings, procedures, FMEAs, protocols and reports.  Collaborate with cross-functional teams including Manufacturing, Quality, R&D to define requirements and identify solutions to drive the delivery of high-quality processes. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements 3+ years hands-on experience with manufacturing and test method development  Engaging personality with strong written & verbal communication skills and an analytical appetite  SAP & Agile Experience in process sustaining engineering.  Experience with lasers, optics and instrumentation (spectrometers, beam profilers, oscilloscopes, etc.)  Experience with RCI and part failures.  Medical Device industry background. o Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems)  Bachelor's degree in a technical discipline, ideally Mechanical or Electrical engineering null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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