Manufacturing Engineer - Fremont, CA

Overview

As the Manufacturing Engineer, you will be responsible for supporting, sustaining, and improving Manufacturing and Quality Operations for Consumables and Instruments produced at the Fremont Site, including the Octet and iQue platforms.

In this role, you will optimize manufacturing processes, ensure product quality, and improve efficiency within our production facilities. This role plays a critical part in the development and implementation of robust manufacturing solutions for our advanced bioanalytical instrumentation.

• Design, develop, and implement manufacturing processes, equipment, and tooling to ensure efficient and high-quality production of bioanalytical instruments.
• Analyze and troubleshoot manufacturing issues, identifying root causes and implementing corrective and preventive actions.
• Lead continuous improvement initiatives using lean manufacturing principles, Six Sigma methodologies, and other problem‑solving techniques to enhance productivity, reduce waste, and improve product reliability.
• Collaborate with R&D, Quality, and Supply Chain teams to facilitate the smooth transition of new products from design to manufacturing.
• Develop and maintain comprehensive manufacturing documentation, including work instructions, process flow diagrams, and standard operating procedures (SOPs).
• Conduct process validations (IQ, OQ, PQ) to ensure compliance with internal standards and regulatory requirements.
• Evaluate and select new manufacturing technologies and equipment, performing cost‑benefit analyses and managing vendor relationships.
• Provide technical support and training to production personnel on new processes, equipment, and quality standards.
• Monitor key performance indicators (KPIs) related to manufacturing efficiency, quality, and cost, and report on progress and areas for improvement.
• Ensure all manufacturing activities comply with relevant health, safety, and environmental regulations.

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical field.
• 3+ years of experience in manufacturing engineering, preferably within the medical device, biotechnology, or a highly regulated manufacturing environment.
• Strong understanding of manufacturing processes, including assembly, testing, and quality control.
• Proficiency in Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
• Experience with CAD software (e.g., Solid Works, AutoCAD) for designing fixtures, tooling, and reviewing product designs.
• Demonstrated ability to troubleshoot complex manufacturing problems and implement effective solutions.
• Excellent analytical, problem‑solving, and project management skills.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across cross‑functional teams.
• Familiarity with Good Manufacturing Practices (GMP) and ISO quality standards (e.g., ISO 13485) is highly desirable.
• Ability to work independently and manage multiple priorities in a fast‑paced environment.
• Identification with our core values:
  Sustainability, Openness, Enjoyment.

As a growing global life science company, we offer a wide range of benefits, including personal and professional development, work‑life balance, meaningful impact, a welcoming culture, health & well‑being, intelligent working environment, retirement savings, flexible spending, and company‑paid benefits.

Sartorius is an equal opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability, or status in any other protected group of class.

E‑Verify Participation Information

E‑Verify Workers Rights

For Residents of California, please review;

CA Privacy Notice for Employees

If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in this opening. You can request accommodation by e‑mail at accom

For additional information and application details, visit