Manufacturing Engineer I

Title: Manufacturing Engineer

Location: Alameda, CA

Duration: 12+ Months

Responsibilities

• Review parts list provided by Product Stewardship and confirmed parts are inactive; therefore, can be removed from the BOM.
• Create supporting documents and preparing MCs and ECs to remove and obsolete parts from BOMs.
• Coordinate and lead the utilization internal/external resources to achieve project goals.
• Understand the business needs of the company and have a thorough understanding of customer needs as they relate to projects.
• Lead and/or participate on cross-functional teams to support organizational goals.
• Serve as subject matter expert (SME) or independent technical expert (ITE) on a project's technical matters; may interface with senior management, external firms, or agencies; may coordinate technical matters between organizations.
• Responsible for completing documentation in a timely manner in accordance with business standards and getting CFT approval on Agile changes (ECs/MCs).
• Responsible for reviewing of Product Change Notification, and creating Supplier Change Notification and Change Impact Assessment.
• Other tasks and duties as assigned.
• Understand and comply with applicable EHS policies, procedures, rules, and regulations.
• Responsible for compliance with applicable Corporate and divisional policies, GMP and performing duties as assigned by management.
  
  

Qualifications

• B.S. degree or equivalent with 2+ years manufacturing experience
• Working knowledge of QSR, ISO, standards relating Document and Data Control. (Prefer experience with Agile software.)
• Excellent written and verbal communication skills are essential.
• Extensive understanding of processes used in the manufacturing of medical devices, particularly handheld devices.
• Create Engineering Change Orders (ECs) in compliance with FDA, QSR, ISO9001, ISO13485 and Abbott standards.
• Conduct ECs review through the department in preparation for the Change Control Board (CCB) review and approval process.
• Assist in resolving moderately complex issues, provide judgments and recommendations to manager.
• Works effectively with others while providing high level customer service.
• Works independently requiring only moderate supervision. Sustains moderate to high judgement on moderately complex non-routine tasks.
• Able to prioritize work.
• Exercises judgement with defined procedures and practices to determine appropriate actions.
  
  

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.