Manufacturing Engineer
Manufacturing Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description Summary
We are looking for a proactive and detail-oriented Manufacturing Engineer to support and optimize production processes within a regulated medical device manufacturing environment. This role is critical in ensuring that products are manufactured efficiently safely and in compliance with FDA ISO and GMP standards. The ideal candidate will work cross-functionally to drive process improvements support new product introductions and maintain high standards of quality and reliability.Job Description
Key Responsibilities:
- Develop implement and optimize manufacturing processes for medical devices ensuring compliance with regulatory and quality standards.
- Supportnew product introductions (NPI)by collaborating with Design Engineering Quality and Production teams.
- Create and maintainprocess documentationincluding work instructions process flow diagrams PFMEAs and control plans.
- Leadroot cause analysisand implementcorrective and preventive actions (CAPA)for process-related issues.
- Identify and implementcontinuous improvementinitiatives using Lean and Six Sigma methodologies.
- Support equipment selection validation (Equipment Qualifications) and maintenance planning.
- Monitor key process metrics and drive improvements in yield cycle time and cost.
- Ensure compliance withinternal quality systems.
Qualifications:
- Bachelors degree in Mechanical Engineering Biomedical Engineering Industrial Engineering or a related field.
- 2 years of experience in a manufacturing engineering role preferably in themedical deviceorregulated life sciencesindustry.
- Strong understanding ofGMPFDA regulations andISO.
- Experience with process validation statistical analysis and root cause investigation.
- Proficiency in CAD software (e.g. SolidWorks AutoCAD Creo) and Microsoft Office tools.
- Excellent problem-solving communication and project management skills.
Preferred Qualifications:
- Experience with cleanroom manufacturing.
- Lean Six Sigma certification (Green Belt or higher).
- Familiarity with ERP and MES systems.
- Knowledge of automation and manufacturing technologies such as Automated Pick and Place Adhesive Dispense Contact and Non-Contact Measurement systems and Wirebonding Equipment.
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: Yes
Employment Type
Full-Time
