Manufacturing Engineer II

# Manufacturing Engineer IIApply
** Job#: 3041613
***
* Job Description:

** Manufacturing Engineer Position Summary We are seeking a Manufacturing Engineer to support the development, optimization, and validation of manufacturing processes within a regulated production environment. This role is responsible for improving manufacturing efficiency, product quality, and overall process performance while collaborating closely with Operations, Quality, R&D, and Supply Chain teams. The ideal candidate is a hands-on problem solver who thrives in a fast-paced environment and is passionate about continuous improvement.

Key Responsibilities
* Develop, implement, and maintain manufacturing processes, procedures, and supporting documentation.
* Design and execute process validations, including IQ, OQ, and PQ activities, to ensure compliance with quality and regulatory requirements.
* Evaluate existing processes and identify opportunities to improve product quality, reduce costs, increase throughput, and shorten cycle times.
* Lead process characterization activities, including Design of Experiments (DOE), data analysis, and performance evaluations.
* Investigate and disposition Non-Conformance Reports (NCRs) and support Corrective and Preventive Action (CAPA) initiatives.
* Recommend, evaluate, and support the acquisition and implementation of manufacturing equipment and tooling.
* Develop production floor layouts and manufacturing workflows to improve operational efficiency and scalability.
* Collaborate with R&D teams to ensure manufacturability of new products and successfully transfer designs into production.
* Work closely with production personnel, including assemblers, supervisors, and team leads, to troubleshoot manufacturing issues and implement solutions.
* Coordinate with suppliers, contractors, and external partners to develop and deploy new manufacturing technologies and processes.
* Utilize data-driven methodologies to improve process capability, reliability, and consistency.
* Facilitate clear communication and collaboration across cross-functional teams to ensure project success.
* Support continuous improvement initiatives focused on safety, quality, delivery, and cost objectives.
* Communicate business risks, opportunities, and project updates to management as required.

Qualifications
* Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline.
* Experience in a manufacturing, medical device, pharmaceutical, or highly regulated production environment preferred.
* Knowledge of process validation methodologies, including IQ/OQ/PQ protocol development and execution.
* Experience with root cause analysis, CAPA investigations, NCR management, and continuous improvement initiatives.
* Familiarity with statistical analysis tools and Design of Experiments (DOE).
* Strong problem-solving, analytical, and troubleshooting skills.
* Excellent written and verbal communication abilities.
* Ability to effectively collaborate with cross-functional teams and production personnel.
* Experience with Lean Manufacturing, Six Sigma, or other process improvement methodologies is a plus.

Preferred Skills
* Process development and optimization
* Equipment qualification and validation
* Regulatory and quality compliance
* Statistical analysis and data interpretation
* Technical documentation and report writing
* Project management and cross-functional leadership

What You'll Bring
* A continuous improvement mindset and passion for manufacturing excellence.
* The ability to balance technical expertise with practical, shop-floor execution.
* Strong attention to detail and commitment to quality.
* A collaborative approach to solving complex manufacturing challenges.

This role offers an opportunity to directly impact product quality, operational efficiency, and manufacturing innovation while working alongside a highly collaborative engineering and operations team.

EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at emp or .

* Everforth Apex is a world-class IT services company that serves thousands of clients across the globe.…