Job Description

Alajuela, Costa Rica

3105-Costa Rica Direct

Qualifications

1. Bachelor's degree in industrial engineering, Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, Business Administration, Operations Management, or a related technical discipline.
2. Minimum of four (4) to five (5) years of experience in a medical device manufacturing environment or other highly regulated industry.
3. Minimum of three (3) years of experience in a supervisory, team lead, or similar people leadership role.
4. Experience working within a Good Manufacturing Practices (GMP) and Quality Management System (QMS) environment.
5. Demonstrated experience managing production personnel, production schedules, and operational performance metrics.
6. Strong computer proficiency, including Microsoft Excel, Word, Outlook, Teams, and manufacturing reporting systems.
7. Ability to respond to manufacturing issues, support floor operations, and maintain an active presence within production areas to ensure safety, quality, and operational performance.
8. Intermediate English proficiency (B1-B2) preferred, both written and verbal.
9. Strong written and verbal communication, coaching, and interpersonal skills with the ability to effectively lead and motivate teams in a fast-paced manufacturing environment.

Desired Qualifications

1. Working knowledge of Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and regulatory requirements applicable to the medical device industry.
2. Familiarity with medical device manufacturing processes, product lifecycle requirements, and regulated production environments.
3. Experience with ERP systems such as SAP or equivalent manufacturing systems preferred.
4. Strong analytical and problem-solving skills, with the ability to interpret operational data, identify trends, perform root cause analysis, and implement effective solutions.
5. Knowledge of manufacturing equipment, production systems, process controls, and equipment troubleshooting methodologies.
6. Ability to utilize production metrics and key performance indicators (KPIs) to drive operational improvements and support business objectives.
7. Experience applying and knowledge of Lean Manufacturing and continuous improvement principles and methodologies and basic problem-solving tools to improve safety, quality, delivery, and operational efficiency.
8. Ability to manage multiple priorities while maintaining compliance with quality and regulatory requirements.
9. Strong organizational and decision-making skills with a demonstrated sense of accountability and ownership.

Physical

1. Extended periods of computer use.
2. Extended periods of sitting, standing, walking, or moving throughout manufacturing and support areas.
3. Light Lifting, up to 25 lbs; occasionally lift, push, pull, or move materials and equipment in accordance with established safety requirements.
4. Extended periods of working in cleanrooms and controlled manufacturing environments, adhering to gowning, contamination control, and hygiene requirements.
5. Personal Protective Equipment (PPE), such as gloves, safety glasses, gowns, masks, hearing protection, and safety footwear may be required in controlled environments.
6. May be exposed to manufacturing equipment, moving machinery, and industrial environments requiring compliance with established Environmental Health & Safety (EHS) procedures.
7. May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).

Posting Country

Outside US