Manufacturing Process Developer

3 weeks ago


Irvine, California, United States Cordis Full time

About Cordis

Cordis is a pioneering medical technology company that specializes in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases.

We are committed to delivering transformative medical solutions that improve the lives of millions. If you are passionate about making a difference and are ready to take on new challenges, then this is the place for you.

Job Summary

The 2nd shift Manufacturing Engineer II will be responsible for developing, evaluating, and optimizing manufacturing processes and methods. This role requires a strong understanding of product design, materials, fabrication processes, tooling, equipment, and quality control standards.

Key Responsibilities

  1. Develop highly capable manufacturing processes for existing products in manufacturing, ensuring robust transition from product development to full-rate production.
  2. Develop and qualify new tooling and equipment.
  3. Draft design of a workspace, including materials and equipment, using computer drafting programs.
  4. Update FMEAs and QCPs for NPI.
  5. Verify and validate processes, machines, and equipment to meet requirements of Company procedures, including IQ/OQ/PQ protocols.
  6. Create and sustain routers and standards.
  7. Troubleshoot product/process-related issues, perform root cause analysis, and develop and implement corrective and preventative action plans.
  8. Interface with all internal organizations to support new product development, introductions, technologies, and supporting systems.
  9. Work with vendors to identify operational equipment and automation solutions.
  10. Develop and manage project plans for major operational improvement activities.

Requirements

  • Bachelor's degree required, engineering or related degree preferred.
  • 2+ years of experience in a manufacturing environment.
  • Class III, IIb Implantable Medical Device experience.
  • Previous experience working in a clean room environment.
  • Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
  • Strong organization and follow-up skills, as well as attention to detail.
  • Ability to work effectively in a team environment.
  • Own project-level goals involving multiple engineers.
  • Break down ambiguous tasks into clear milestones to ensure progress can be measured.
  • Knowledge of Validation/Verification process, Gage R&R, and a clear understanding of FDAs QSR and GMP.
  • Working knowledge of process flow, value stream analysis, operations demands, and operator requirements.
  • Proficiency in CAD software (e.g. Solidworks) for 3D modeling, design analysis, and manufacturing drawings.
  • Understanding of statistical analysis.
  • Ability to compose thorough and detailed technical documentation, job aids, procedures manuals, etc.
  • Strong analytical, problem-solving, and project management skills.
  • Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA, and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.

Pay and Compensation

The expected pre-tax pay rate for this position is $73,700 - $100,000. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge, and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammates' points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable, and welcoming.



  • Irvine, California, United States ELLWOOD National Forge Full time

    Join ELLWOOD National Forge as a Manufacturing Engineer I and contribute to the development of innovative manufacturing processes. Your expertise will be essential in standardizing work instructions and control plans for semi-finished and finished parts.Key responsibilities include:Developing and implementing manufacturing process improvementsStandardizing...


  • Irvine, California, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineer II to join our team at Planet Pharma. This role will be responsible for designing and implementing manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.Key ResponsibilitiesDesign and implement...


  • Irvine, California, United States Primary Talent Partners Full time

    Manufacturing Engineer OpportunityPrimary Talent Partners is seeking a skilled Manufacturing Engineer to join a leading medical device company in Irvine, CA. This 12-month contract position offers a competitive hourly rate of $45.00-$53.00 and potential for extension or conversion.Key Responsibilities:Design and implement efficient manufacturing processes...


  • Irvine, California, United States Primary Talent Partners Full time

    Primary Talent Partners is seeking a highly skilled Manufacturing Engineer to join a multinational medical device company in Irvine, CA.Key Responsibilities:Designs manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.Develops manufacturing processes that are...


  • Irvine, California, United States Turion Space Full time

    Job SummaryTurion Space is seeking a highly skilled Manufacturing Process Engineer to join our team. As a key member of our manufacturing team, you will be responsible for designing, implementing, and improving manufacturing processes and systems to enhance efficiency, quality, and safety.Key ResponsibilitiesProcess Design: Develop and implement...


  • Irvine, California, United States Turion Space Full time

    Job SummaryThe 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 continuous improvement.Key...


  • Irvine, California, United States Infotree Global Solutions Full time

    Job Role: Manufacturing Engineer IIJob Location: Irvine, CAJob Duration: Long-term contractJob Description:Required skills:Process Validation experience for medical devicesSupporting manufacturing and investigating non-conformancesCycle time, Yield and Process Flow improvement experienceDocumentation - BOM, Work Instructions, visual aids, MP, change order...


  • Irvine, California, United States Turion Space Full time

    Job Summary:Turion Space is seeking a skilled Manufacturing Engineer to join our team. As a key member of our production team, you will be responsible for designing, implementing, and improving manufacturing processes and systems to enhance efficiency, quality, and safety.Key Responsibilities:Develop and implement manufacturing processes and procedures to...


  • Irvine, California, United States INTELLECTT INC Full time

    **Job Summary**The role of a manufacturing process engineer at INTELLECTT INC involves applying engineering principles to optimize industrial layouts and manufacturing production. Key responsibilities include analyzing time, motion, methods, and speed to establish standard production rates and improve efficiency.**Key Responsibilities:**Study production...


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

    Job Summary:As a Manufacturing Process Improvement Specialist at B. Braun Medical Inc., you will play a critical role in enhancing the efficiency and productivity of our manufacturing operations. This position requires a strong analytical mindset, excellent communication skills, and the ability to work collaboratively with cross-functional teams to drive...


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

    Job Summary:As a Process Tech at B. Braun Medical Inc., you will play a crucial role in ensuring the efficient production of our medical products. Your responsibilities will include operating machines and production equipment, monitoring quality, and maintaining accurate records. If you have a strong background in manufacturing and are looking for a...


  • Irvine, California, United States Compunnel, Inc. Full time

    Job DescriptionWe are seeking a highly skilled Manufacturing Engineer to join our team at Compunnel Inc. The ideal candidate will have a strong background in industrial engineering and a proven track record of improving production efficiency.Key Responsibilities:Conduct efficiency analysis to identify areas for improvement and develop strategies to increase...


  • Irvine, California, United States Compunnel Full time

    Job Summary:The Manufacturing Process Specialist plays a crucial role in optimizing industrial operations and manufacturing production. This position involves applying engineering principles to enhance operational efficiency and quality assurance standards.Key Responsibilities:Efficiency Analysis: Conduct thorough studies to establish standard production...


  • Irvine, California, United States Recruitlink Full time

    Job DescriptionThe Manufacturing Engineer plays a pivotal role in optimizing industrial processes and manufacturing production. This position involves applying engineering principles to enhance operational efficiency and productivity.Key Responsibilities:Efficiency Analysis: Conduct thorough studies to establish standard production rates and improve overall...


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

    B. Braun Medical Inc., a leading innovator in infusion therapy and pain management, seeks a highly skilled Manufacturing Process Improvement Specialist to join its Irvine Facility team. As a key contributor to the company's mission to eliminate preventable treatment errors and enhance patient, clinician, and environmental safety, this role will play a...

  • Cost Engineer

    4 weeks ago


    Irvine, California, United States United Software Group Full time

    We are seeking a highly skilled Cost Engineer to join our team at United Software Group INC. The ideal candidate will have a strong background in manufacturing process knowledge and experience with aPriori should costing tool.Key Responsibilities:Perform in-depth knowledge of manufacturability / producibility practices specific to Mechanical...


  • Irvine, California, United States JobRialto Full time

    Job Summary: As a Manufacturing Engineer at JobRialto, you will play a pivotal role in applying engineering principles to drive industrial layout and manufacturing production excellence. This position involves creating engineering drawings and interpreting blueprints to enhance operational efficiency.Key Responsibilities:Efficiency Analysis: Conduct thorough...

  • Process Controller

    4 weeks ago


    Irvine, California, United States AtWork - Santa Ana Full time

    We're seeking a skilled Process Controller to oversee the quality and efficiency of our forging processes and products. Key responsibilities include:Monitoring and Control: Continuously observe and track production processes to ensure optimal performance and product quality.Quality Assurance: Ensure products meet specified quality standards by checking for...


  • Irvine, California, United States Masimo Full time

    Job SummaryThe Process Engineer is responsible for the development, improvement, and validation of new and existing manufacturing processes, equipment, tooling, and fixtures. This position leads and/or supports new process development (NPI) and product transfers to world-wide manufacturing facilities, implements and supports/utilizes effective manufacturing...

  • Process Engineer

    4 weeks ago


    Irvine, California, United States Masimo Full time

    Job SummaryThe Process Engineer is responsible for the development, improvement, and validation of new and existing manufacturing processes, equipment, tooling, and fixtures. This position leads and/or supports new process development (NPI) and product transfers to world-wide manufacturing facilities, implements and supports/utilizes effective manufacturing...