Sr. Manufacturing Engineer

3 weeks ago


Santa Rosa, United States Endologix Full time

Overview:

Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

Responsibilities:
  • Design and develop manufacturing processes for new products and/or changes to existing products
  • Design and develop fixtures and tooling for manufacturing process
  • Develop and execute process validation protocols (IQ/OQ/PQ)
  • Analyze process data and make decisions/recommendations relating to process capability and DFM
  • Perform Installation Qualification (IQ) equipment protocols and reports
  • Investigate benefits and features of capital equipment and generate capital appropriation justifications
  • Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions
  • Provide engineering support to production department in troubleshooting and resolving technical problems.
  • Contact and address component and/or raw material issues with suppliers
  • Support manufacturing and quality with addressing NCMR issues
  • Plan, schedule, and complete projects in a manner consistent with business objectives
  • Contribute to the intellectual property position of the company via invention and patent applications
  • Maintain accurate documentation of concepts, designs, and processes.
  • Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
  • Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved
  • Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
  • Ensure that all regulatory and internal policies are followed
  • Assist engineering manager in development of engineers providing assistance with coaching and mentoring
  • Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
  • Perform other duties as assigned by supervisor
Qualifications:
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • Has the ability to use moderate to advanced statistic techniques when analyzing data and make rational and logical decision base the that analysis
  • Applicable knowledge of Minitab, JMP, or other statistic tools
  • Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill)
  • May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
  • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

Education:

  • Requires a Bachelop of Science degree in Engineering or related technical degree (i.e. physics or mathematics)

Experience:

  • Five years with a Bachelor's degree, Three years with a Master's degree of directly relevant

Compensation: $82,000 to $130,000.00 annual salary depeding on experience



  • Santa Rosa, United States Avispa Technology Full time

    Manufacturing Engineer 1307149 A leading technology company is looking for a Manufacturing Engineer. The successful candidate will be responsible for reviewing process flow data between MES/ERP systems to make sure the data matches, you will work closely with process engineers and process experts to ensure a smooth transition from one MES system to...


  • Santa Rosa, United States Meet Full time

    Meet has recently partnered up with a medical device company in Santa Rosa, CA developing innovative therapies for the interventional treatment of vascular disease with the first of its kind, class III cardiovascular implant. The client is looking for a seasoned manufacturing engineer to join their NPI team. This is a fully onsite role with relocation...


  • Santa Rosa, United States Meet Full time

    Meet has recently partnered up with a medical device company in Santa Rosa, CA developing innovative therapies for the interventional treatment of vascular disease with the first of its kind, class III cardiovascular implant. The client is looking for a seasoned manufacturing engineer to join their NPI team. This is a fully onsite role with relocation...


  • Santa Rosa, United States Meet Full time

    Responsibilities:Develop manufacturing processes for new products and modifications to existing ones.Create fixtures and tooling necessary for the manufacturing process.Execute process validation protocols (IQ/OQ/PQ).Analyze process data to enhance process capability and Design for Manufacturability (DFM).Conduct Installation Qualification (IQ) equipment...


  • Santa Rosa, United States Meet Full time

    Responsibilities:Develop manufacturing processes for new products and modifications to existing ones.Create fixtures and tooling necessary for the manufacturing process.Execute process validation protocols (IQ/OQ/PQ).Analyze process data to enhance process capability and Design for Manufacturability (DFM).Conduct Installation Qualification (IQ) equipment...


  • Santa Rosa, United States Meet Full time

    Responsibilities: Develop manufacturing processes for new products and modifications to existing ones. Create fixtures and tooling necessary for the manufacturing process. Execute process validation protocols (IQ/OQ/PQ). Analyze process data to enhance process capability and Design for Manufacturability (DFM). Conduct Installation Qualification (IQ)...

  • SR. EHS Engineer

    1 week ago


    Santa Paula, United States Insight Global Full time

    Insight Global is seeking a Sr. EHS Engineer to join our largest manufacturing clients in the Monrovia, CA area. This resource will be responsible for various areas, including industrial hygiene assessments, regulatory compliance, safety committee leadership, and support for equipment design and installation. They will conduct ongoing assessments surrounding...

  • Sr. QA Engineer

    2 days ago


    Santa Ana, United States Talentry LLC Full time

    Job DescriptionSr. QA EngineerDirect Hire. Medical Device.Santa Ana, CA. 100-140k DOETalentry is looking for an Sr. Quality Assurance Engineer for our diagnostics device design and manufacturing client. The right QE is going to enrure that all applicable regulations are followed. This includes, but is not limited to, ISO13485, 21 CFR part 820, ISO14971 etc....


  • Santa Rosa, United States Medtronic, plc Full time

    The Sr. EHS Specialist will act as a business partner to a variety of R&D groups as well as manufacturing. The Sr. EHS Specialist will have ownership over a defined number of EHS programs that are part of a comprehensive EHS Management system. Progra Environmental, Mental Health, Specialist, Health, Safety, Senior, Manufacturing, Healthcare


  • Santa Ana, United States Talentry LLC Full time

    Job Description Sr. Electrical Engineer Medical Device. Direct-Hire Santa Ana, CA Talentry is looking for a Senior Electrical Engineer to design, build, and test PCBs and other electronic systems (motors, sensors, laser/LEDs, actuators, thermodynamic systems, etc.) He or she will work with the team to perform schematic capture through the final board layout,...


  • Santa Ana, United States TalentCORE, Inc. Full time

    Opportunity to join a leading aerospace company engaged in the manufacture and assembly of precision-machined structural aircraft components and assemblies for tolerance critical applications. POSITION SUMMARY: Under routine supervision, determines, for simple to complex, generally customer-specific programs, the optimal manufacturing methods and processes...


  • Santa Ana, United States TalentCORE, Inc. Full time

    Opportunity to join a leading aerospace company engaged in the manufacture and assembly of precision-machined structural aircraft components and assemblies for tolerance critical applications. POSITION SUMMARY: Under routine supervision, determines, for simple to complex, generally customer-specific programs, the optimal manufacturing methods and processes...

  • Sr. Engineer, AI

    4 days ago


    Santa Clara, United States Balbix Full time

    ENGINEERING Balbix, Inc. in San Jose, CA seeks Sr. Engineer, AI: Design & develop classical & deep learning algorithms to model this data to assess the cyber-security risk using mathematical programming libraries such as Scikit-learn, PyTorch, & Ten-sorFlow. $170,186 /yr. - $180,186/yr. Email res (must reference Job Code 41778) to HRbalbix.com.


  • Santa Clara, United States Kelly Science, Engineering, Technology & Telecom Full time

    Kelly Engineering Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, is currently seeking a Sr Systems Verification Engineer for a long-term engagement at one of our Global Medical Device Robotics & Digital Solutions clients in Santa Clara, CA. A global leader in surgery with products and solutions...


  • Santa Clara, United States Kelly Science, Engineering, Technology & Telecom Full time

    Kelly Engineering Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, is currently seeking a Sr Systems Verification Engineer for a long-term engagement at one of our Global Medical Device Robotics & Digital Solutions clients in Santa Clara, CA. A global leader in surgery with products and solutions...


  • Santa Rosa, CA, United States CyberCoders Full time

    Santa Rosa, CA Full-time $175,000.00 - $220,000.00Posted 05/01/2024My client, a leader in the pharmaceutical industry is seeking an experienced Head of Manufacturing for an immediate hiring need. They specialize in products in digestive, skin, cough and cold and allergy markets. They are pharmaceutical company with branded products over the counter and...


  • Santa Rosa, United States Tellus Solutions Full time

    This position is in our PICO microassembly area in Santa Rosa, California. We manufacture modules in support of our internal customers. You will be part of the team in automated or manual assembly. This team is responsible for the production of micro circuits. In PICO you are responsible for the quality and consistency of the parts; your work affects the...


  • Santa Rosa, United States Avispa Technology Full time

    Manufacturing Design Ops Support (Swing) 1316456 A leading technology company is looking for a Manufacturing Design Ops Support - Quality (Swing). The successful candidate will be responsible for performing inspection of sub-assemblies or final assemblies of our products. The ideal candidate has 4+ years of related experience. The company offers...


  • Santa Rosa, United States Avispa Technology Full time

    Job DescriptionJob DescriptionDFM Technician 1319839 A leading technology company is looking for a Design for Manufacturing (DFM) Technician. The successful candidate will be an integral part of the New Product Introduction (NPI) team working on the latest R&D designs with a focus on high quality designs and aggressive time-to-market scheduling. The ideal...


  • Santa Clara, United States Insight Global Full time

    Required Skills and Experience *- Mechanical Design background- Strong knowledge of basic manufacturing processes including CNC machining, injection molding, sheet metal production, coating technologies, and finishing operations- B.S. or M.S. in Mechanical or Industrial Engineering- Experience with CreoNice to Have Skills and Experience-2-3+ years of...