Catheter Manufacturing Engineer II

1 week ago

Fremont, California, United States BioTalent Full time

MAIN PURPOSE OF JOB:


The Manufacturing Engineer is in close collaboration with Operations, NPI Engineering, Design & Development, and Purchasing to support Catheter Manufacturing for the Operations team.

You will be involved in the design and development of fixtures and processes to scale manufacturing of catheters.

You will be responsible for documentation, and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on process and efficiency improvements, clinical builds, training production, preparation, and execution of process validation for new version of products.


MAIN JOB RESPONSIBILITIES:


We are actively looking for a Manufacturing Engineer II who can bring innovation and creative thinking to the team on catheter-based devices.

As a Manufacturing Engineer II, you will be primarily responsible for maintaining, developing, and implementing cost-effective manufacturing processes and methods.

You will provide day to day support of the catheter manufacturing floor operations from an engineering perspective.

Manufacturing Engineers document processes, implement ideas and solutions to improve assembly operations and reduce costs, develop tooling/fixturing, drive investigations tied to non-conformances.

Experience with validations, risk management, and Lean Principles is preferred.

ESSENTIAL RESPONSIBILITIES

Develops and implements robust cost-effective manufacturing processes and improves product flow and product quality and safety performance for both sustained and new products.

Leads assigned customer transfer of new products to production including establishing assembly time and yield targets, training needs and quality control.

Develops, tests and implements tools, fixtures and equipment required for manufacturing processes.
Develop and maintain manufacturing process instructions, inspection plans and lot history travelers.

Leads creation of manufacturing process validation plans, validation protocols and reports, and implements manufacturing process validations and test method validations.

Collaborates with cross-functional teams including customer during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM).
Maintains process risk documentation (e.g. PFMEA) to identify potential risks, and implement preventive and corrective actions
Manages and/or supports production and test equipment maintenance, qualification and calibration.
Performs analysis for cost reduction, and quality and efficiency improvement.
Prepares engineering change orders and coordinates the implementation of changes including training production staff.

Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures.

Dispositions non-conforming products and develops required re-work procedures and processes.
Communicates with customers regarding process improvements, fixture development, and production changes
Perform other responsibilities duties as assigned.

This is not a remote position. The position requires to work onsite and support the production floor daily.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

POSITION REQUIREMENTS:
Knowledge / Education
BS in Mechanical / Biomedical / Industrial Engineering or in an equivalent engineering discipline
3-5+ years of experience in catheter based medical device process development and/or manufacturing engineering
Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies highly preferred
Experience with new product introduction and interactions daily with customers development teams
Solid knowledge of GMP and ISO 13485 regulations
Must be able to review and interpret technical drawings and specifications. Proficiency in Solidworks preferred.
Strong computer skills, including the MS Office suite
Must be able to read, write and speak fluent English, and must possess excellent communication and presentation skills, both written and oral
Must have demonstrated organizational skills to manage multiple priorities and schedules.

WHAT WE OFFER
A fast-paced work environment
Paid time off
401(k) retirement savings with a company match
Clean, and well-lit production areas
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

#J-18808-Ljbffr

  • Manufacturing Engineer II

    4 weeks ago

    Fremont, California, United States Penumbra Full time

    As a member of the Manufacturing Engineering group at Penumbra, you will be called upon to solve complex problems and implement innovative solutions. You will provide manufacturing technology and robust solutions aimed at commercializing new products and continuously improving production processes. Working cross-functionally with engineering groups across...

  • Manufacturing Engineer II

    1 month ago

    Fremont, California, United States Penumbra Full time

    As a member of the Manufacturing Engineering group at Penumbra, you will be called upon to solve complex problems and implement innovative solutions. You will provide manufacturing technology and robust solutions aimed at commercializing new products and continuously improving production processes. Working cross-functionally with engineering groups across...

  • Electro-Mechanical Assembler II

    1 week ago

    Fremont, California, United States Axelon Full time

    Position Title: Electro-Mechanical Assembler II Location: Fremont, CA Hours: 5:30 AM-1:30 PM Pay rate:35- 37/hr. Job Description: As an Electro-Mechanical Assembler II in our Image Guided Therapy Business, you will have the opportunity to build balloon catheter products that save lives. This includes performing a variety of repetitive and non-repetitive...

  • Manufacturing Engineer

    1 week ago

    Fremont, California, United States CalTek Staffing , Inc. Full time

    3-6 month contract. Pay is $40-$50/Hour The Manufacturing Engineer is involved in the design of the company's manufacturing/quality processes and once the process is in place, this individual is responsible for running and maintaining the process as well as seeking ways to continually improve the process. The process of continuous improvement requires the...

  • Metrology Engineer II

    1 week ago

    Fremont, California, United States Confluent Medical Technologies Full time

    Confluent Medical Technologies is committed to collaborating with clients in the medical industry to bring their projects from initial prototypes to full-scale production.With our exceptional technical know-how, vast experience, and strong partnerships, we have mastered the process of producing top-notch medical devices using cutting-edge material science,...

  • Manufacturing Engineer

    1 week ago

    Fremont, California, United States CUES Full time

    Manufacturing Engineer Location: Fremont, California, United States Building the people that build the world. With platforms in HVAC and Detection and Measurement, SPX Technologies builds innovative solutions that enable a safer, more efficient, sustainable world. Through our RiSE talent development framework, we Reach, Identify, Strengthen, and Engage...

  • Manufacturing Engineer

    1 week ago

    Fremont, California, United States CUES Full time

    Manufacturing Engineer Location:Fremont, California, United States Building the people that build the world. With platforms in HVAC and Detection and Measurement, SPX Technologies builds innovative solutions that enable a safer, more efficient, sustainable world. Through our RiSE talent development framework, we Reach, Identify, Strengthen, and Engage our...

  • Manufacturing Engineer

    1 week ago

    Fremont, California, United States SPX Full time

    Job Title: Manufacturing Engineer at SPX Technologies SPX Technologies is a global company dedicated to building innovative solutions in the HVAC and Detection and Measurement industry, making the world a safer, more efficient, and sustainable place. As a part of the Detection and Measurement sector, TCI leads with innovative spectrum monitoring and signals...

  • Manufacturing Technician Ii

    1 week ago

    Fremont, California, United States Y.C. Cable USA, Inc. Full time

    YC Cable USA, Inc., a dynamic, rapidly expanding international cable assembly manufacturer locate in Fremont CA, seeks the following:Mechanical Technician Level IIJob SummaryThe Mechanical Technician Level II assumes a high level of responsibility early, supporting our field teams in their delivery of client services. Successful Mechanical Technicians are...

  • Manufacturing Engineer

    1 week ago

    Fremont, California, United States Cytek Biosciences Full time

    SUMMARY:The Manufacturing Engineer (ME) will be expected to lead parallel high impact projects and helps with continuous and uninterrupted flow of the production process. The ME is expected to contribute new ideas and find innovative methods to accomplish production goals. Works on complex mechanical, electrical, and optical problems where analysis of...

  • Senior Manufacturing Engineer

    1 week ago

    Fremont, California, United States Lam Research Full time

    The Group You'll Be A Part OfThe Global Operations Group brings information systems, facilities, supply chain, logistics, and high-volume manufacturing together to drive the engine of our global business operations. We help Lam deliver industry-leading solutions with speed and efficiency, while actively supporting the resilient and profitable growth of Lam's...

  • Senior Manufacturing Process Engineer

    1 week ago

    Fremont, California, United States Sila Nanotechnologies Full time

    Job DescriptionJob DescriptionAbout UsWe are Sila, a next-generation battery materials company. Our mission is to power the world's transition to clean energy. To create this future, our team is building a better lithium-ion battery from the inside out today. We engineer and manufacture ground-breaking battery materials that significantly increase the energy...

  • Manufacturing Associate

    1 week ago

    Fremont, California, United States Compunnel, Inc. Full time

    Job DescriptionJob DescriptionDescription:Responsibilities:Duties:Executes fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.Executes independently with adequate...

  • Manufacturing Supervisor

    1 week ago

    Fremont, California, United States Philips Full time

    Job TitleManufacturing Supervisor (Fremont, CA)Job DescriptionThe Philips Image Guided Therapy Devices Angiosculpt manufacturing plant-based in Fremont, CA. You are building the product in a "Clean Room" environment with manual assembly, UV adhesive bonding, thermal bonding, ultrasonic processing, and leak testing.Your role: Creates a working environment...

  • Manufacturing Supervisor

    4 weeks ago

    Fremont, California, United States Philips Full time

    Job TitleManufacturing Supervisor (Fremont, CA)Job DescriptionThe Philips Image Guided Therapy Devices Angiosculpt manufacturing plant-based in Fremont, CA. You are building the product in a "Clean Room" environment with manual assembly, UV adhesive bonding, thermal bonding, ultrasonic processing, and leak testing.Your role: Creates a working environment...

  • Manufacturing Supervisor

    1 week ago

    Fremont, California, United States Philips Full time

    The Philips Image Guided Therapy Devices Angiosculpt manufacturing plant-based in Fremont, CA. You are building the product in a "Clean Room" environment with manual assembly, UV adhesive bonding, thermal bonding, ultrasonic processing, and leak testing. Your role: Creates a working environment that continuously improves the Health and Safety of workers,...

  • Project Engineer

    4 weeks ago

    Fremont, California, United States FATHOM Full time

    Location: Fremont, CAWould you like to be at the forefront of manufacturing? We are looking for an Additive Project Engineer to support sales of our additive products. Fathom Manufacturing ) accelerates manufacturing innovation for the most product driven companies in the world. Fathom seamlessly blends in-house capabilities across plastic and metal...

  • Project Engineer

    1 month ago

    Fremont, California, United States FATHOM Full time

    Location: Fremont, CAWould you like to be at the forefront of manufacturing? We are looking for an Additive Project Engineer to support sales of our additive products. Fathom Manufacturing ) accelerates manufacturing innovation for the most product driven companies in the world. Fathom seamlessly blends in-house capabilities across plastic and metal...

  • Equipment Engineer

    1 week ago

    Fremont, California, United States LanceSoft Full time

    Title: Equipment Engineer roleLocation: 47540 Kato Rd Fremont California 94538Duration: 6+months contract RESPONSIBILITIESDevelop and implement automotive assembly equipment and toolsIdentify the manufacturing design opportunities by aligning with teams on proposed process changes and improvementsManage manufacturing partners that support us with the...

  • Equipment Engineer

    1 week ago

    Fremont, California, United States LanceSoft Full time

    Title: Equipment Engineer roleLocation: 47540 Kato Rd Fremont California 94538Duration: 6+months contractRESPONSIBILITIES Develop and implement automotive assembly equipment and tools Identify the manufacturing design opportunities by aligning with teams on proposed process changes and improvements Manage manufacturing partners that support us with the...