Job Description

Location MV

Alajuela, Costa Rica

Department Name

3212-CR-Engineering

Qualifications

1. Bachelor’s degree in mechanical engineering, industrial engineering, electrical engineering, or related field.
2. Minimum of seven (7) years of experience in medical device environment or similar field.
3. Minimum of three (3) years leading end-to-end product transfers across sites.
4. Minimum of three (3) years of experience in management capacity, overseeing teams, resources, and operational initiatives.
5. Demonstrated experience with Process validation (IQ/OQ/PQ) and manufacturing process development and scale-up.
6. Working knowledge of FDA 21 CFR 820, ISO 13485 and Quality Management System.
7. Strong experience in Lean Manufacturing and/or Six Sigma methodologies.
8. Strong written and verbal communication skills.
9. Proficiency in statistical analysis tools, Minitab or equivalent.
10. Demonstrated mindset of ownership, urgency, and accountability in execution.
11. Written and verbal English proficiency (minimum B2+).
12. Proficiency computer skills, including Excel, MS Word, Excel, Power Point, Outlook, Teams.
13. Valid passport and Visa.

Desired Qualifications

1. Project Management Professional (PMP) certification or equivalent experience applying structured project management methodologies.
2. Strong understanding of design transfer processes (DHF to DMR) and transfer governance (phase-gate, transfer agreements, quality plans).
3. Experience operating in a highly regulated environment with strong documentation practices (GDP discipline and audit readiness).
4. Proven ability to lead and influence cross-functional and cross-site teams in a matrix organization.
5. Experience in driving operational improvements using Lean, Six Sigma, or continuous improvement methodologies.
6. Strong analytical and problem-solving skills, with demonstrated ability to make data-driven decisions.
7. Advanced proficiency in project planning and reporting tools (e.g., dashboards, project trackers).

Physical

• Extended periods of computer use.
• Extended periods of sitting, standing, or speaking.
• Light lifting, up to 25 lbs.
• May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).
• International travel as required up to (50%).