PURPOSE OF JOB We seek to hire a Sr. Manufacturing Engineer that will be responsible for needle manufacturing in Costa Rica.
This role will own the manufacturing process as well as the associated business processes required to establish, improve, and maintain the needle production process.
RESPONSIBILITIES Lead installation and set-up of new and transferred equipment.
Develop deep understanding, through characterization and other means, of the various manufacturing processes.
Perform equipment and process validations per QMS requirements.
Take ownership of the manufacturing processes identifying and executing opportunities for Safety improvements.
Scrap reduction/control.
Process optimization.
Capacity maximization.
Workflow.
Develop and implement training programs for junior engineers, product builders and other personnel as needed.
Work with Quality personnel to address and remedy CAPAs, NCMRs, SCARs, assist in Regulatory audits and other product quality concerns.
Maintain and track machine availability, seek assistance of facilities and other support resources, both internal and external, as the need arises.
Own the development and optimization of Routers, Bills of Materials (BOM), Device History Records (DHR), and other pertinent QMS documentation, including incorporation into the ERP system.
Conduct studies of equipment/operational capacities/workflow/and methods to improve processes, labor utilization, and efficiencies.
Utilize Operational Excellence methodologies to make improvements to process to improve process capability & quality.
Responsible for reviewing and analyzing product costs, manufacturing methods, and processes on a continual basis, identify, plan, and implement cost improvements.
Develop recommendations and justifications for new capital equipment.
Assist in the introduction of new products and in product development.
Provide guidance and assistance to other manufacturing areas as needed.
Develop tooling/fixtures to facilitate production.
Other responsibilities as assigned.
REQUIREMENTS EDUCATION : Bachelor's degree in mechanical engineering or equivalent Professional fluency in English is essential (C1), both written and oral. EXPERIENCE : 5-10 years of experience in manufacturing operations ( required ) Experience in Medical device manufacturing experience ( required ) Experience with cost reduction/scrap reduction efforts ( required ) Familiarity with Statistical analysis and process control ( required ) PREFERRED QUALIFICATIONS : Six Sigma and Lean manufacturing experience (preferred) Needle manufacturing experience (preferred) Experience with ECG, Plasma Welding, or grinding machines (preferred) POSITION SKILLS Excellent problem-solving skills Excellent organizational skills Must possess strong work ethic OTHER: Occasional travel to the United States will be required.
A valid U.S. travel visa and an up-to-date passport will be necessary.
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