Manufacturing Equipment Engineer Lead

4 weeks ago

San Jose, California, United States BioFire Diagnostics Full time
Job Summary

The Manufacturing Equipment Engineer Lead will be responsible for the sustainment and performance of production equipment to maintain employee safety and meet productivity and quality goals. This position will work with cross-functional teams to implement and improve manufacturing equipment performance and capability.

Key Responsibilities
  • Troubleshoot manufacturing equipment to ensure production continuity and document failure analysis and corrective actions per quality management system and GMP requirements.
  • Communicate to production staff in a timely manner about equipment status and repairs progress.
  • Diagnose and debug complex optical/electro/mechanical equipment, computer systems, coupled with software solutions.
  • Direct meetings with cross-functional teams to discuss technical issues in detail, create consensus on path forward and until issues resolved.
  • Identify systemic performance issue, design, and implement effective and sustained mitigations and repairs to enhance overall productivity.
  • Author equipment troubleshooting procedures and create postmortem reports to document troubleshooting activities, technical findings, and repairs.
  • Lead the hands-on training to other engineers and technicians to improve knowledge and response times.
  • Drive equipment initiatives to improve product quality, increase part throughput, decrease equipment downtime, and strengthen safety measures.
  • Lead the cross-functional team to identify the new equipment specifications to scale up production capability, upgrade current equipment and introduce new technology.
  • Manage internal and/or external equipment builder and spearhead equipment deployment to production line.
  • Optimize manufacturing equipment during validation and qualification (IQ/OQ/PQ).
  • Produce Verification/Validation protocols (IQ/OQ/PQ) and related technical reports to support the transfer of new products, processes, and equipment into production.
  • Lead failure investigations and root cause analyses as they relate to equipment performance.
  • Oversee the Calibrations and Preventive Maintenance (PM) requirement (procedures and schedule) for all manufacturing equipment, including performing the critical PM activities.
  • Manage critical spare parts inventory to ensure business continuity.
  • Comply to GMP and GDP guidelines and QMS documentation requirement.
  • Other duties or support assigned by the manager.
Requirements
  • Bachelor of Science in mechanical, manufacturing or biomedical engineering with 7 years of relevant experience or equivalent combination of education and experience to perform at this level.
  • Minimum 3 years of working in a regulated environment (GMP, ISO or FDA).
  • Proficient with equipment troubleshooting, repairs, validations, and calibration and PM in a regulated environment.
  • Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment and ambiguous scope.
  • Strong project management, oral and written communication, and interpersonal skills.
  • Proficient with electro-mechanical troubleshooting, pneumatics, system/SW integration, PLC, or vision system.
  • Must be able to read and understand mechanical/pneumatic drawings and electrical schematics.
  • Experience with 3D design packages (Solidworks, Inventor, Pro E).
  • Experience with creating BOMs, product specifications, and engineering drawings interpretation (GD&T).
  • Ability to work under pressure and stringent timelines to recover equipment down situations.
  • Proven ability to quickly diagnose problems through analysis of inspection reports, system log files, system parametric diagnostic data and other test results, and provide clear and comprehensive solutions.
  • Hands-on experience with high volume and fast pace medical device manufacturing equipment.
  • Extensive experience with semi-automated equipment troubleshooting, root cause analysis, equipment engineering, failure investigations and automated assembly equipment.
  • Proven experience with mechanical design concepts, machinery and automation: Electrical, Mechanical, and Electromechanical schematics, motors, pumps, vacuum, and hydraulics.
  • Prior experience with ink jet printers, or micro volume dispense technology would be a plus.
Benefits

This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program. The estimated salary range for this role based in California is between $122,400 and $152,400. bioMérieux offers a competitive Total Rewards package that may include: A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options. Company-Provided Life and Accidental Death Insurance. Short and Long-Term Disability Insurance. Retirement Plan including a generous non-discretionary employer contribution and employer match. Adoption Assistance. Wellness Programs. Employee Assistance Program. Commuter Benefits. Various voluntary benefit offerings. Discount programs. Parental leaves.

  • Manufacturing Engineer

    4 weeks ago

    San Jose, California, United States MILLENNIUMSOFT Full time

    Job SummaryMillenniumsoft is seeking a highly skilled Manufacturing Engineer to join our team. The ideal candidate will have a strong background in manufacturing operations, with experience in leading cross-functional project teams and implementing process improvements.Key Responsibilities* Lead multiple high-impact projects simultaneously, driving change...

  • Manufacturing Equipment Technician

    4 weeks ago

    San Jose, California, United States Jabil Full time

    Job SummaryWe are seeking a skilled Manufacturing Equipment Technician to join our team at Jabil. As a key member of our manufacturing team, you will be responsible for performing preventative maintenance, calibration, and repair of automated manufacturing equipment.Key ResponsibilitiesPerform preventative maintenance, calibration, and repair of automated...

  • Principal Manufacturing Equipment Specialist

    3 weeks ago

    San Jose, California, United States BioFire Diagnostics Full time

    Job SummaryThe Associate Principal Manufacturing Equipment Engineer will be responsible for the sustainment and performance of production equipment to maintain employee safety and meet productivity and quality goals. This position will work with cross-functional teams to implement and improve manufacturing equipment performance and capability.Key...

  • Senior Manufacturing Engineer

    4 weeks ago

    San Jose, California, United States PROCEPT BioRobotics Full time

    Transforming Healthcare with PROCEPT BioRoboticsAs a Senior Manufacturing Engineer at PROCEPT BioRobotics, you will play a critical role in driving quality, delivery, and cost improvements across the company. With a strong background in engineering and project management, you will own critical internal and contract manufacturing processes, ensuring seamless...

  • Senior Manufacturing Engineer

    4 weeks ago

    San Jose, California, United States PROCEPT BioRobotics Full time

    Transforming Healthcare with PROCEPT BioRoboticsEmbark on a rewarding journey with PROCEPT BioRobotics, where innovation and passion drive our mission to revolutionize treatment for benign prostatic hyperplasia (BPH). As a Senior Manufacturing Engineer, you will play a critical role in scaling up disposable manufacturing processes in a cleanroom environment,...

  • Senior Manufacturing Engineer

    3 weeks ago

    San Jose, California, United States PROCEPT BioRobotics Full time

    Job DescriptionAt PROCEPT BioRobotics, we are seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of our manufacturing organization, you will be responsible for owning critical internal and contract manufacturing processes.Key Responsibilities:Take ownership of engineering support for both in-house and contract...

  • Manufacturing Engineering Lead

    3 weeks ago

    San Diego, California, United States Parker Hannifin Corporation Full time

    Job SummaryWe are seeking a highly skilled Senior Manufacturing Engineer to join our team at Parker Hannifin Corporation. As a key member of our manufacturing team, you will be responsible for planning, developing, and implementing manufacturing methods, processes, and operations for new and existing composite aerospace products and assemblies.Key...

  • Senior Manufacturing Engineer

    3 weeks ago

    San Jose, California, United States Noah Medical Full time

    About the Role:Noah Medical is seeking a highly skilled Senior Manufacturing Engineer to join our team. As a key member of our manufacturing team, you will be responsible for sustaining and improving our manufacturing processes to ensure the highest quality products.Key Responsibilities:Develop and implement process improvements to increase efficiency and...

  • Manufacturing Process Engineer

    3 weeks ago

    San Jose, California, United States MILLENNIUMSOFT Full time

    Job Description:At MillenniumSoft, we are seeking a highly skilled Manufacturing Engineer to join our team. As a key member of our engineering team, you will be responsible for leading multiple high-impact projects simultaneously, driving change, and contributing new ideas to improve manufacturing operations.Key Responsibilities:Lead cross-functional project...

  • Manufacturing Quality Engineer

    4 weeks ago

    San Jose, California, United States Supermicro Full time

    About SupermicroSupermicro is a leading provider of advanced server, storage, and networking solutions for data centers, cloud computing, enterprise IT, and other industries. We are committed to delivering high-quality products and services that meet the evolving needs of our customers.Job SummaryWe are seeking a skilled Manufacturing Quality Engineer to...

  • Senior PCB Manufacturing Engineer

    3 weeks ago

    San Jose, California, United States Sanmina-SCI Full time

    Job Title: Senior PCB Manufacturing EngineerJob Summary:Sanmina Corporation, a leading integrated manufacturing solutions provider, is seeking a Senior PCB Manufacturing Engineer to join our team. As a key member of our engineering team, you will be responsible for developing, ramping, and sustaining new and existing products and methods in close cooperation...

  • Manufacturing Process Engineer

    4 weeks ago

    San Jose, California, United States Foxconn Full time

    Job Title: Manufacturing Engineer (SMT/Wave)About the Company: Foxconn is a leading electronics manufacturing company that requires a skilled Manufacturing Engineer to join our team.Job Function: As a Surface Mount Technology (SMT) Process Engineer, you will be responsible for assisting in the production line of surface mount technologies, which involve...

  • Principal Equipment Engineer

    4 weeks ago

    San Jose, California, United States Western Digital Full time

    Job SummaryWestern Digital is seeking a highly skilled Principal Equipment Engineer to join our team. As a key member of our equipment design and installation team, you will be responsible for the design, installation, and qualification of complex tooling and equipment for our media deposition and semiconductor manufacturing processes.Key Responsibilities...

  • Manufacturing Engineer III

    3 weeks ago

    San Jose, California, United States Takara Bio USA, Inc. Full time

    About the Role:The Manufacturing Engineer III is a critical position at Takara Bio USA, Inc. responsible for ensuring manufacturing excellence through careful development and execution of quality and technical procedures. This role requires a senior engineer with a sound engineering background to lead process and design changes, troubleshoot advanced...

  • Manufacturing Engineering Internship Opportunity

    4 weeks ago

    San Jose, California, United States Stryker Corporation Full time

    Job Summary: We are seeking a highly motivated Manufacturing Engineering Intern to join our team at Stryker Corporation. As a Manufacturing Engineering Intern, you will provide engineering support to our manufacturing process, project, or function. Your responsibilities will include sustaining manufacturing lines, evaluating manufacturing outcomes, and...

  • Manufacturing Lead Engineer

    3 weeks ago

    San Marcos, California, United States Parabilis Space Technologies Inc Full time

    About Parabilis Space SystemsWe are a leading developer of affordable in-space propulsion and small satellite solutions. Our team of experts designs, develops, tests, and flies innovative space technologies that meet the current and future needs of our customers.As the Lead Engineer for Manufacturing, Assembly, Integration, and Test at Parabilis, you will be...

  • NPI Engineer

    3 weeks ago

    San Jose, California, United States Sanmina-SCI Full time

    Job Title: NPI Engineer - PCB Manufacturing SpecialistJob Summary:Sanmina Corporation is a leading integrated manufacturing solutions provider serving the fastest growing segments of the global Electronics Manufacturing Services (EMS) market. We are seeking a highly skilled NPI Engineer to join our team in developing, ramping, sustaining, and cost-optimizing...

  • Manufacturing Engineer II

    3 weeks ago

    San Jose, California, United States MILLENNIUMSOFT Full time

    Job Summary:Millenniumsoft is seeking a highly skilled Manufacturing Engineer II to join our team. As a key contributor within the Instruments Manufacturing department, you will be responsible for both manufacturing engineering and project management responsibilities. You will work with projects or problems of small to moderate scope, requiring good...

  • Manufacturing Engineer II

    3 weeks ago

    San Jose, California, United States MILLENNIUMSOFT Full time

    Job Summary:The Manufacturing Engineer II is a key contributor within the Instruments Manufacturing department. This role has both a manufacturing engineering and a project manager responsibility in working with projects or problems of small to moderate scope that require good judgment, with little management involvement. The successful candidate will lead...

  • Senior Technical Lead for Manufacturing Processes

    3 weeks ago

    San Jose, California, United States MILLENNIUMSOFT Full time

    Job SummaryWe are seeking a skilled Senior Manufacturing Engineer to join our team at MillenniumSoft. The ideal candidate will have a strong background in manufacturing engineering, with experience in leading cross-functional teams and implementing process improvements. This is a challenging and rewarding role that requires strong technical expertise,...