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Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. Job title - Senior Production Engineer/Senior Specialist Location - Pleasanton, CA (fully Onsite) This position will design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality. MAIN RESPONSIBILITIES: Manage projects including new production equipment, process improvements, and cost reductions, supporting new product introductions. Provide guidance to engineers and technicians. Provide technical mentorship to engineers and technicians. Conduct Process FMEAs and Process Validations. Improve product quality, labor efficiency, and throughput using Lean manufacturing concepts. Coordinate the design, procurement, build, and debug of tooling, machinery, and test equipment. Collaborate with Product Development to ensure Design for Manufacturability. Work independently and innovatively, demonstrating excellent organization, problem-solving, communication, and team leadership skills. Effectively collaborate with cross-functional teams. Support company initiatives aligned with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Ensure compliance with FDA regulations, company policies, operating procedures, and maintain positive communication with all stakeholders. Education requirements: Bachelor's Degree (± 16 years) in Mechanical, Chemical, or related engineering or technical field, or equivalent work experience. Experience Details: Minimum 5 years manufacturing engineering experience, with medical device experience required. International manufacturing experience preferred. Strong analytical, problem-solving, and project management skills. Six Sigma certification preferred. Proven leadership in team settings. Experience in a cross-division, enterprise environment preferred. Ability to work in a fast-paced, dynamic environment and travel approximately 25%, including internationally.

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