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Quest Global

Engineering services, digital transformation, asset management

Lead Configuration Engineer - Medical Device

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timePune, Maharashtra, IndiaIn-person

About the Job

Requirements

  • Completed engineering studies at university level; BE/BTech/ME/M-Tech in Mechanical, Electrical, Electronics Engineering, or an equivalent stream.
  • Eight to twelve years of work experience in product configuration management.
  • Expertise in CAD-E and CAD-M tools for data integrity purposes.
  • Expertise in data storage and transfer tools such as Agile, Windchill, SAP-PLM, SAP-IPPe, PDX, or ODB++.
  • Expertise in version control of TPD, CAD-E, and non-volatile PL data.
  • Experience transferring data on PCBAs and assemblies to and from relevant suppliers, including engineering change and end-of-life issues.
  • Ability to work independently and as part of a team.
  • Ability to guide and mentor young engineers on the team.
  • Ability to present and articulate ideas to key stakeholders and the leadership team.
  • Communication skills and a positive, proactive attitude.
  • A quality mindset in design and documentation.

Responsibilities

  • Check the integrity of CAD-E, associated assemblies, and CAD-M data.
  • Transfer and exchange data with suppliers.
  • Act as the interface between Philips and suppliers to resolve DMR issues.
  • Consult on applicable standards, tools, and assembly processes.
  • Manage component lifecycles and trigger actions to mitigate obsolescence risks.
  • Complete installed-base searches and quality analysis.
  • Suggest process improvements for data integrity, including ECR and EOL, data transfer, and data storage.
  • Assist low- to frequent-use users with data transfer and archiving.
  • Assist with CAD-E tool validation.
  • Create relevant ECRs and associated actions based on specific EOL triggers.
  • Create and maintain documentation for tools used to support configuration management.
  • Monitor configuration management processes.
  • Provide users with support and troubleshooting for configuration management software issues.
  • Perform Change Admin 1 and 2 duties for MR Therapy Products, and for overall MR systems when the respective Configuration Designer is absent.
  • Conduct DCRB and OCCB meetings for MR Therapy Products, and for overall MR systems when the respective Configuration Designer is absent.
  • Gather input from the product configuration team for Best for MAXBOM changes in MR Therapy Products.
  • Review change notices from the Therapy Hardware Team and support the PMO with analysis of impacted parts, including where-used analysis.
  • Conduct DCRB reviews.

Desired Qualifications

  • Experience in medical device development and knowledge of IEC 60601 standards.
  • Knowledge of global medical quality and regulatory standards such as IEC, FDA, UL, CE, and CSA.

About the Company

Quest Global

Engineering services, digital transformation, asset management

QuEST Global provides engineering and lifecycle services across aerospace, automotive, energy, healthcare, and transportation, focusing on digital transformation and asset management. It uses edge computing, cloud, AI/ML, and industrial IoT to deliver tailored engineering solutions through long-term partnerships, service contracts, project-based engagements, and strategic collaborations. It differentiates itself with a broad industry footprint, global delivery model, and emphasis on partnerships, talent development, and workplace culture. Its goal is to help clients improve operational efficiency and drive business growth by transforming engineering processes and assets with digital tools and data-driven management.

Company size
10,001+
Company stage
Growth Equity (Venture Capital)
Total funding
$581M
Headquarters
Greenville, SC
Founded
1997

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