Equipment Engineer (Junior)

Boston Scientific; Penang; On-site; MYR 60,000 - 80,000; Full time

Job summary

A global medical technology company is seeking an Equipment Engineer to ensure quality by validating software applications and equipment according to specifications. Responsibilities include developing project specifications, managing documentation, and executing validation protocols. The ideal candidate should hold a Bachelor's Degree in Engineering and have 3-5 years of relevant experience, with strong skills in project management and technical documentation. This role is based in Penang, Malaysia, and may require overseas travel.

Qualifications

• Minimum 3-5 years of experience in equipment engineering.
• Proven track record in product transfers and equipment qualification.
• Experience in working within a matrix organization.

Responsibilities

• Develop comprehensive specifications for equipment.
• Execute software validation protocols and record results.
• Create documents and manage Change Requests.

Skills

Project management

Technical documentation

Root cause analysis

Process improvement methodologies

Education

Bachelor’s Degree in Engineering (Mechanical, Manufacturing, or related field)

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.