Job Description

Purpose Statement:
To ensure the quality of Boston Scientific Corporation's software applications and equipment by validating/qualifying to specifications. Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations.
Job Respondsibilities:

• Participate in project teams to develop comprehensive specifications (hardware and/or software) for equipment with minimal functionality such as fixtures, PLC's, and simple Visual Basic applications.

• Provide project estimates with assistance from senior/principle engineers.

• Submit specification, protocol and report for approvals and documentation control via a Change Request.

• Develop comprehensive software validations and/or 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 the team can meet delivery requirements.

• Create documents, links and Change Requests utilizing a Product Data Management system.

• Provide basic information on software validations and equipment installation qualifications. Support Equipment Installation & Qualification and retrofits

• Incident Management: Manages Equipment failure outlining impact on the business, recovery plan, and resources required.

• Generates weekly and Monthly metrics on Equipment downtime, MTTR, MTBF, Cost, Improvement activity, PM compliance, and resource management.

• Ensure Work carried out as part of Primo is as per procedures.

• Manages spares usage.

• Drives the Area Improvement Team Meeting to deliver pre-determined goals.

• Continuously drives the 'up-skill' of Maintenance Techs with TSG and other set-up documents.

Job Requirements:

• Candidates must possess at least Bachelor's Degree in Engineering (Mechanical, Manufacturing, or related field).
• Required at least minimum 3-5 years of experience in equipment engineering.
• Proven track record in product transfers, equipment qualification, and equipment setup and improvement.
• Experience in working within a matrix organization and cross-site collaboration.
• Strong project management and technical documentation skills.
• Proficient in equipment qualification protocol/report writing (ESQ).
• Skilled in root cause analysis and process&equipment improvement methodologies.
• Wiling to travel for oversea assignment/training.

About Us
As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.

Skills Required