Manufacturing Quality Engineer (Contract)

Manufacturing Engineer (Contract)

RESPONSIBILITIES

• Developing, implementing, and continuously improving manufacturing processes to enhance yield, reduce costs, and improve productivity.
• Representing Process Engineering in R&D and Project Team meetings, providing technical expertise in technology transfers, analytical method development, validation, and process scale-up.
• Conducting or managing process validations (IQ/OQ, OQ, PQ).
• Troubleshooting production line issues related to yield, quality, and throughput.
• Leading scaling up processes from development to full-scale manufacturing.
• Supporting evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
• Creating/updating manufacturing instructions, routings, bills of materials, and SOPs.

QUALIFICATIONS

• Minimum 4-5+ years of experience of medical device manufacturing.
• Experience with Design Transfer and Process Validations at external suppliers (CMO).
• Write and execute associated validations.
• Strong analytical and problem-solving skills (DOE, SPC, Six Sigma)
• Knowledge on Class II/Class III medical device manufacturing and related quality system regulations.
• Demonstrates ability to consistently meet proposed timelines, applying competent use of project planning and project management skills.
• Excellent oral and written communication skills; ability to communicate with technical and non-technical audiences.
• Ability to effectively provide direction and support to external partners/suppliers.
• Experience with electromechanical assemblies is preferred
• Design for Manufacturing experience is preferred.
• Fixture development experience is preferred.
• Experience in early stage of product development is preferred.

EDUCATION

• Bachelors in Biomedical, Manufacturing, Mechanical Engineering, or related life sciences discipline
• Six Sigma Certification.