Manufacturing Engineer I (2nd Shift)
About The Position
This role provides day-to-day engineering support to manufacturing operations during 2nd shift activities. The Manufacturing Engineer I will support production processes by investigating yield issues and implementing corrective actions. They will also assist in engineering investigations related to nonconformances, product performance, and manufacturing deviations. The position involves participating in testing method development, troubleshooting, and validation support activities, as well as supporting minor device redesigns and engineering changes to improve manufacturability and product performance. The engineer will analyze customer returns, support root cause investigations and corrective/preventive actions, and collaborate with suppliers and internal teams to support supplier-related changes and material evaluations. Key responsibilities include identifying and implementing cost optimization and process improvement opportunities, utilizing statistical analysis and data trending tools, and supporting Lean Manufacturing and continuous improvement initiatives. The role also requires preparing technical documentation, reports, and engineering records in compliance with company procedures and regulatory requirements, and collaborating with Quality, Manufacturing, Supply Chain, and R&D teams to support operational goals. Ensuring compliance with GMP, quality systems, and applicable regulatory standards is essential. Other duties may be assigned.
Requirements
- Bachelor’s degree in Engineering.
- 1–3 years of experience in the medical device industry.
- Strong analytical and problem-solving skills.
- Knowledge of Lean Manufacturing and continuous improvement methodologies.
- Ability to work in a team-oriented and fast-paced manufacturing environment.
- Production support engineering experience
- Yield improvement and engineering investigation experience
- Microsoft Office
Nice To Haves
- Yellow Belt or Green Belt knowledge preferred.
- Strong verbal and written communication skills in English and Spanish preferred.
- Minitab
- Lean Manufacturing methodologies
- Root cause analysis tools
- Statistical analysis and data trending
- Medical device manufacturing processes
Responsibilities
- Provide day-to-day engineering support to manufacturing operations during 2nd shift activities.
- Support production processes by investigating yield issues and implementing corrective actions.
- Assist in engineering investigations related to nonconformances, product performance, and manufacturing deviations.
- Participate in testing method development, troubleshooting, and validation support activities.
- Support minor device redesigns and engineering changes to improve manufacturability and product performance.
- Analyze customer returns and support root cause investigations and corrective/preventive actions.
- Collaborate with suppliers and internal teams to support supplier-related changes and material evaluations.
- Identify and implement cost optimization and process improvement opportunities.
- Utilize statistical analysis and data trending tools to monitor manufacturing performance and support decision-making.
- Support Lean Manufacturing and continuous improvement initiatives.
- Prepare technical documentation, reports, and engineering records in compliance with company procedures and regulatory requirements.
- Collaborate with Quality, Manufacturing, Supply Chain, and R&D teams to support operational goals.
- Ensure compliance with GMP, quality systems, and applicable regulatory standards.
- Other duties may be assigned.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
