Our client is a highly respected organization within the manufacturing industry, recognized for delivering innovative, high-quality solutions to a global customer base. They are committed to operational excellence and continuous improvement, leveraging advanced technologies to remain competitive and forward-thinking. With a collaborative, performance-driven culture, the company empowers employees to take ownership of their work while supporting professional growth and long-term career development. This is an excellent opportunity to join a stable, reputable organization that values integrity, quality, and its people.
Key Responsibilities:
- Leading validation efforts including IQ, OQ, and PQ protocols to ensure manufacturing compliance and quality standards.
- Collaborating with design teams to update and refine process specifications and manufacturing procedures.
- Managing and owning multiple projects, driving initiatives to improve process efficiency and reduce scrap.
- Communicating effectively with cross-functional teams across various locations to coordinate production activities.
- Analyzing manufacturing data and troubleshooting issues to maintain continuous process improvement and operational stability.
- Conducting process development and validation activities to support product sustainment and manufacturing transfer initiatives.
- Documenting and updating SOPs, work instructions, and validation protocols to ensure regulatory compliance and process consistency.
Qualifications:
- Bachelor’s degree in Mechanical, Industrial, Biomedical Engineering, or related field.
- 0-2 years of manufacturing engineering experience, with a focus on validation (IQ/OQ/PQ), process development, and continuous improvement.
- Proven project ownership and ability to lead complex tasks across multiple functions.
- Strong mechanical, industrial, or biomedical engineering foundation.
- Experience working in regulated environments such as Med Dev, Pharma, Biotech, Aerospace, or Defense.
- Skilled in documentation (SOPs, process development, work instructions) and validation protocols.
- Familiarity with electromechanical assembly and manufacturing transfer processes.
- Proficiency with manufacturing software, including ERP systems like SAP or AS400.
- Experience in electromechanical assembly environments and sustaining operations.
- Background in process validation and transfer within medical device manufacturing.
- Knowledge of ISO 13485, ISO 9001, FDA, or EUMDR regulations.
- Project management skills and experience managing multiple concurrent projects.
- Exposure to PLM systems and process improvement methodologies.
- NO C2C CANDIDATES
JBL is an Equal Opportunity Employer and E-Verify Company