Position Summary
Under the general direction of the Engineering Manager, the Manufacturing Engineer is responsible for supporting the introduction and scale-up of new products within a cleanroom assembly environment. This role focuses on developing, validating, and optimizing manufacturing processes to ensure efficient, compliant, and high-quality production. The Manufacturing Engineer will work cross‑functionally with Design, Quality, and Operations teams to support New Product Introduction (NPI) from concept through to full production. This is an onsite role. Contract: 12‑23 months, Full time, primarily on‑site, day rate contract, start mid‑June.
What You Will Do
Support New Product Introduction (NPI) activities, including process development, equipment selection, and production readiness for cleanroom assembly.
Develop and maintain manufacturing process documentation, including work instructions, SOPs, process flow diagrams, and validation protocols.
Collaborate with cross‑functional teams (R&D, Quality, Supply Chain, and Production) to ensure smooth transfer from design to manufacturing.
Assist in the design and implementation of cleanroom‑compliant assembly processes, ensuring adherence to contamination control and regulatory requirements.
Participate in process validation activities (IQ/OQ/PQ) and support execution of validation protocols and reports.
Identify and implement process improvements to enhance yield, efficiency, and product quality within the cleanroom environment.
Troubleshoot and resolve process, equipment, and product issues, performing root cause analysis and implementing corrective and preventive actions (CAPA).
Support line setup, pilot builds, and production ramp‑up, ensuring processes are stable and capable.
Work with Quality Assurance to support non‑conformance investigations, deviations, and audit readiness.
Monitor key performance metrics such as yield, cycle time, and defect rates, and take appropriate action to address gaps.
Assist in managing engineering changes (ECRs/ECNs) and ensure proper implementation on the production floor.
Provide technical support and training to production operators and technicians within the cleanroom environment.
All other duties as assigned.
What You Will Need
2+ years experience in a manufacturing engineering role.
Understanding of cleanroom operations and contamination control practices (experience is a strong advantage).
Knowledge of process validation (IQ/OQ/PQ).
Familiarity with manufacturing process development, including documentation and standardisation.
Strong problem‑solving skills with experience in root cause analysis and continuous improvement methodologies (e.g., Lean, Six Sigma).
Ability to read and interpret engineering drawings, specifications, and BOMs.
Proficiency in tools such as MS Office, ERP/MRP systems, and basic data analysis tools.
Strong communication and teamwork skills, with the ability to collaborate across multiple functions.
Ability to work in a fast‑paced NPI environment, managing multiple priorities and meeting deadlines.
Experience supporting cleanroom assembly processes is a distinct advantage.
Demonstrated ability to adapt to a dynamic, regulated manufacturing environment.
Desired Skills and Experience
Cleanroom
Validation
Process Validation
Manufacturing Engineering
IQ
OQ
PQ
Process Development
NPI
Lean
Six Sigma
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