Sr. Manufacturing Engineer

3 weeks ago


Irvine, United States Willow Laboratories Full time

Job Summary:


This position will be an integral part of our medical technology company that develops and manufactures innovative medical devices. This position works with a cross-functional team from Engineering, Manufacturing and Quality to validate, launch and scale device and consumable manufacturing. This position will support continuous improvement activities in the areas of process, labor and cost. The Manufacturing Engineer will provide process development and validation expertise for the Manufacturing Team to support the development and scale of new products and accessories for patient monitoring technologies.


Duties & Responsibilities:


  • Plans and directs assigned project activities. Performs both process development and validation activities.
  • Leads team activity to modify plans as appropriate if problems arise and improves/supports existing processes.
  • Must work with limited supervision and will be involved in and have input to project planning.
  • Clearly communicates directions. influences people in adopting the best solutions, tools, working practices and promotes cooperation in defining an excellent technical product.
  • Directs and facilitates the validation of manufacturing processes to assure process and product reliability. Leads the development of validation protocols and reports.
  • Interfaces with technical peers and senior level managers to maintain mutual understanding of product development needs, regulatory and production requirements.
  • Generates complete documentation for validation of manufacturing processes and associated manufacturing processes (work instructions, DHR’s, maintenance and calibration procedures, etc.)
  • Develops systems and processes for high volume production.
  • Designing and implementing automated processes.


Minimum Qualifications and Experience:


  • BS in Mechanical Engineering or related field.
  • 10+ years Manufacturing Experience in the medical device field.
  • Experience with new production lines and processes from start up through scale.
  • Experience in taking a major device from development to customer shipment.
  • High volume consumables and cost of goods reduction experience
  • Knowledge of standard assembly techniques in manufacturing and associated validation approaches
  • Manufacturing experience working in cleanrooms and associated operating requirements.
  • Advanced understanding and use of statistical analysis principles and tools (Minitab, etc.) as they relate to data analysis and testing reports
  • Working knowledge with sterilizations processes and sterilization vendors
  • Experience in writing, setup and control of documentation systems.
  • Product packaging experience
  • Excellent conceptual, analytical, and problem-solving ability.
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering and manufacturing personnel.
  • Experience working with manufacturing and automation vendors
  • Experience in leading projects to completion
  • Prior Medical device manufacturing experience, with working knowledge of:
  1. FDA 510(k) approval process
  2. ISO standards
  3. GMP regulations
  • Experience working in both large structured and small entrepreneurial organizations.


Desired Qualifications:

  • Experience working with microliter volume pumps and actuation.
  • Knowledge of biomedical materials (e.g., metals, plastics, adhesives).
  • Experience with site transfers.


Physical requirements/Work Environment


This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary; therefore the ability to operate a motor vehicle and maintain a valid Driver’s license is required.


The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.



  • Irvine, CA, United States Willow Laboratories Full time

    Job Summary: This position will be an integral part of our medical technology company that develops and manufactures innovative medical devices. This position works with a cross-functional team from Engineering, Manufacturing and Quality to validate, launch and scale device and consumable manufacturing. This position will support continuous improvement...


  • Irvine, United States PARKER HANNIFIN CORP Full time

    Org Marketing Statement Sr. Manufacturing Engineer, Product Support Team - Fluid Systems DivisionParker Hannifin is a Fortune 250 global leader in motion and control technologies. For more than a century, the company has been enabling engineering breakthroughs that lead to a better tomorrow.Parker Aerospace, an operating segment of Parker Hannifin...


  • Irvine, California, United States Cordis Full time

    About the JobCordis is seeking a Sr Manufacturing Engineering Technician to join our team and contribute to the development of innovative medical devices for the treatment of cardiovascular diseases. Key ResponsibilitiesDevelop highly capable manufacturing processes for existing products, ensuring robust transition from product development through full-rate...


  • Irvine, United States Sound United Full time

    Sr Engineer II, Equipment & Maintenance JOB DETAILS:  Engineer, Equipment is responsible for overseeing equipment for overseeing equipment maintenance, equipment troubleshooting, maximizing overall equipment efficiency, reducing equipment downtime by providing guidance to technicians, solving technical challenges related to automated semiconductor...

  • Sr. Systems Engineer

    2 weeks ago


    Irvine, United States Terran Orbital Corporation Full time

    Be more than just an employee number! Join Terran Orbital, a leader in innovation, manufacturing, and operations in the satellite industry. We are a pioneer in the miniaturization of space technologies and the delivery of responsive space solutions. We are a unique, fast-growing, and trusted team focused on quickly and economically designing, building,...


  • Irvine, United States ZipRecruiter Full time

    Job DescriptionJob DescriptionDescriptionThe Manufacturing Engineer will be responsible for designing, implementing, and improving manufacturing processes and systems to enhance efficiency, quality, and safety. This role involves working closely with cross-functional teams to develop and refine manufacturing methods, solve production issues, and drive...


  • Irvine, United States Aequor Information Technologies Pvt. Ltd. Full time

    Manufacturing Engineer IILocation: Irvine CADuration: 18+Months Job Summary: Develops and improves manufacturing processes by studying product and manufacturing methods. Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with...


  • Irvine, United States ELLWOOD NATIONAL FORGE CO Full time

    We are seeking a highly skilled Mechanical Engineer to join our team at ELLWOOD National Crankshaft in Irvine, PA. The ideal candidate will have a strong background in mechanical design, manufacturing processes, and quality assurance. Through the adoption of the Continuous Improvement mindset, ELLWOOD National Crankshaft strives to improve on the core...


  • Irvine, United States B. Braun Medical Inc Full time

    B. Braun Medical, Inc.Interested in this role You can find all the relevant information in the description below.Sr. Manufacturing Engineer -Plastics Engineering (Mon-Fri 7:00am-3:30pm)US-CA-IrvineJob ID: 2024-25301Type: Regular Full-Time# of Openings: 1Category: EngineeringIrvine FacilityOverviewAbout B. Braun B. Braun Medical Inc., a leader in infusion...

  • Sr. GNC Engineer

    3 weeks ago


    Irvine, United States Terran Orbital Corporation Full time

    Be more than just an employee number! Join Terran Orbital, a leader in innovation, manufacturing, and operations in the satellite industry. We are a pioneer in the miniaturization of space technologies and the delivery of responsive space solutions. We are a unique, fast-growing, and trusted team focused on quickly and economically designing, building,...


  • Irvine, United States Rivian Full time

    About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we constantly challenge what's possible, never simply accepting what has always been done. We reframe old problems, seek new solutions and...


  • Irvine, United States Actalent Full time

    Job Title: Manufacturing Engineer For immediate consideration, please apply directly to this job posting AND email habels @actalentservices.com with the following: 1) Word copy of resume2) 2-3 professional references3) 4-5 brief bullet points highlighting technical qualificationsJob DescriptionAs a Manufacturing Engineer, you will provide engineering...


  • Irvine, United States Advanced Technology Search Full time

    We are working on behalf of a leading maker of RF ICs and RF Front End Modules for mobile, WIFI and other fast-growing markets. They also use SAW and BAW technology for RF Filters. They are looking for a Sr. Principal Wafer Bonding Integration Engineer.As the company adapts and improve its’ SAW /BAW product, your responsibility will be to provide optimal...


  • Irvine, United States ELLWOOD National Crankshaft Full time

    We are seeking a highly skilled Mechanical Engineer to join our team at ELLWOOD National Crankshaft in Irvine, PA. The ideal candidate will have a strong background in mechanical design, manufacturing processes, and quality assurance. Through the adoption of the Continuous Improvement mindset, ELLWOOD National Crankshaft strives to improve on the core...


  • Irvine, United States ZipRecruiter Full time

    Job DescriptionJob DescriptionDescriptionThe Lead Manufacturing Engineer will oversee and guide the manufacturing engineering team, focusing on designing, implementing, and refining manufacturing processes and systems. This role requires a strong leader with a deep understanding of manufacturing practices, a track record of successful project management, and...


  • Irvine, United States Turion Space Full time

    Lead Manufacturing EngineerDepartment: Vehicle Design / Analysis / Integration Employment Type: Full Time Location: Irvine, California Reporting To: Deepak Grover Compensation: $120,000 - $170,000 / year Description The Lead Manufacturing Engineer will oversee and guide the manufacturing engineering team, focusing on designing, implementing, and refining...


  • Irvine, United States Actalent Full time

    Job Title: Manufacturing Engineer For immediate consideration, please apply directly to this job posting AND email habels @actalentservices.com with the following: Word copy of resume 2-3 professional references 4-5 brief bullet points highlighting technical qualifications Job Description As a Manufacturing Engineer, you will provide engineering...

  • Sr. GNC Engineer

    3 weeks ago


    Irvine, CA, United States Terran Orbital Corporation Full time

    DescriptionBe more than just an employee number! Join Terran Orbital, a leader in innovation, manufacturing, and operations in the satellite industry. We are a pioneer in the miniaturization of space technologies and the delivery of responsive space solutions. We are a unique, fast-growing, and trusted team focused on quickly and economically designing,...


  • Irvine, United States Actalent Full time

    Job Title: Manufacturing Engineer For immediate consideration, please apply directly to this job posting AND email [email protected] with the following: 1) Word copy of resume2) 2-3 professional references3) 4-5 brief bullet points highlighting technical qualificationsJob DescriptionDaily work includes engineering support of existing products and...


  • Irvine, United States LanceSoft, Inc. Full time

    Title: Manufacturing EngineerLocation: Irvine, CA – 92614Duration: 10 MonthsShift: 2:00 PM to 10:30 PM Main Responsibilities:The manufacturing engineer will develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; recommend and implement improvements to production...