Manufacturing Engineer - Fremont, CA

Sartorius•Fremont, CA

1d•Onsite

About The Position

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 be responsible for optimizing manufacturing processes, ensuring product quality, and improving 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. What you will accomplish together with us: 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.

Requirements

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., SolidWorks, 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.
Ability to work independently and manage multiple priorities in a fast-paced environment.

Nice To Haves

Familiarity with Good Manufacturing Practices (GMP) and ISO quality standards (e.g., ISO 13485) is highly desirable.
Identification with our core values: Sustainability, Openness, Enjoyment

Responsibilities

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.

Benefits

Personal and Professional Development: Mentoring, leadership programs, internal seminar offerings
Worklife Balance: Paid vacation, sick time, corporate holidays and community service day; as well as flexible work schedules
Making an Impact Right from the Start: Comprehensive onboarding, including a virtual online platform
Welcoming Culture: Mutual support, team spirit and international collaboration; communities on numerous topics such as “Coaching”, “Agile Working” and a “Businesswomen’s Network”
Health & Well Being: Wide selection of health and well-being support such as a variety of medical plans to choose from, dental, vision, EAP, and other wellness programs.
Intelligent Working Environment: Working in smart buildings with the latest technology and equipment.
Retirement Savings Plan: 401 k (with generous company match)
Flexible Spending: HSA, FSA (dependent care & healthcare spending), Transportation Commuter Account
Company Paid Benefits: Basic Life Insurance, AD&D, EAP, Family Planning & Women’s Health, Health Advocate
Additional/Optional: Supplemental Life Insurance (employee, spouse & dependents), Legal Services, LTD & STD, Critical Illness Insurance, Student Loan Tuition Refinance Service