Equipment Engineer

2 days ago

Penang, Malaysia Boston Scientific Medical Device (Malaysia) Sdn. Bhd. Full time $60,000 - $120,000 per year

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.

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