Boston Scientific Principal Process & Equipment Engineer 

Costa Rica, Cartago 

590506019

Hybrid Roles:

About the Role:

Responsible for providing engineering support and expertise, specific to equipment controls, software and automation in the definition, design and test of products through engineering solutions that meet regulatory requirements.

Your Responsibilities Include:

• Develop comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
• Provide project estimates independently and review quotes of Engineer I’s, II's and Senior Engineers (as needed).
• Submit specification, protocol and report for approvals and documentation control via a Change Request.
• Develop comprehensive software validations and equipment installation qualification protocols per the specification.
• Execute software validation and/or qualification protocols & record results.
• Document, communicate and follow-up on software/equipment issues.
• Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements.
• Create documents, links and Change Requests utilizing a Product Data Management system.
• Provide expert information on FDA/QSR regulations and corporate and internal process validation policies pertaining to software validations, electronic records & signatures, equipment qualifications to project team.
• Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations.
• Provide guidance, mentoring and training to Engineer I's & II's and Senior Engineers. Ensure consistency of work among Engineer I's & II's. Provide peer reviews on specifications, protocols and reports.
• Drive the standards for validating and qualifying new technologies and/or software systems cross-functionally.
• Influences and defines functional, departmental, divisional and corporate policies and procedures through involvement with cross-functional engineering initiatives.
• Provide leadership role on championing functional best practices.
• Develop and review comprehensive validation procedures in compliance with FDA.

What We’re Looking For:

• Licentiate degree in Mechanical, Electromechanical, Electronic, Electrical Industrial Maintenance or related.
• English Level: C1: 90-94%.
• Desired knowledge: Automation Technologies (Robotics, PLC, Vision, Motion, Sensing, etc.); EquipmentDesign, Building & Machining; Equipment Maintenance; Tools (2D & 3D CAD, Statistics, Technical Manuals); Problem Solving Methodologies.
• At least 7 years of experience in similar position.