The Manufacturing Engineer is responsible for developing, implementing, validating, and continuously improving manufacturing processes and equipment to support the production of medical devices. This role provides technical support to manufacturing operations, leads process improvement initiatives, and ensures compliance with quality, regulatory, and safety requirements. The successful candidate will collaborate with cross-functional teams to improve product quality, operational efficiency, and manufacturing performance.
Key Responsibilities
- Support daily manufacturing operations by troubleshooting process and equipment issues.
- Develop, optimize, and validate manufacturing processes and production equipment.
- Lead process improvement, cost reduction, and productivity enhancement initiatives using Lean and Six Sigma methodologies.
- Execute process validations (IQ/OQ/PQ) and support equipment qualifications.
- Analyze manufacturing data, identify trends, and implement corrective actions.
- Develop and maintain manufacturing documentation, procedures, and engineering reports.
- Support new product introductions, process transfers, and capacity expansion projects.
- Participate in root cause investigations, CAPA activities, and quality improvement efforts.
- Lead and manage engineering projects to meet business objectives.
- Collaborate with Quality, Operations, Maintenance, Supply Chain, and other cross-functional teams.
- Ensure compliance with GMP, FDA, ISO 13485, and applicable regulatory requirements.
- Provide technical leadership, training, and support to manufacturing personnel.
Requirements
- Bachelor’s Degree in Industrial Engineering, Mechanical Engineering, Electromechanical Engineering, Electrical/Electronic Engineering, or related engineering discipline.
- 3+ years of manufacturing engineering experience, preferably within the medical device industry.
- Advanced English communication and technical writing skills.
- Experience in highly regulated manufacturing environments.
- Experience with process validation, continuous improvement, and project leadership.
- Strong problem-solving and analytical abilities.
- Demonstrated success leading projects involving quality improvements and cost reductions.
- Experience with Lean Manufacturing, Six Sigma, GMPs, and process validation.
- Proficiency with Microsoft Office Suite, Minitab, data analysis, and project management tools.
- Ability to manage multiple projects and work effectively in cross-functional teams.
- Broad knowledge of manufacturing processes and technologies.
Preferred Competencies
- Strong project management and leadership skills.
- Results-oriented with a proven track record of achievement.
- Excellent communication and presentation skills.
- Ability to work independently and drive initiatives to completion.
- Effective problem-solving and decision-making capabilities.
- Adaptability and ability to thrive in a fast-paced environment.
- Customer-focused, innovative, and committed to continuous improvement.
- Experience leading team members.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
To read and review this privacy notice click here
