Lead Configuration Engineer (Medical Device)

Quest Global; Maharashtra; On-site; INR 2,400,000 - 4,200,000; Full time

Benefits offered by this job

Group medical insurance coverage

Group term life insurance coverage

Group personal accident insurance

Staff loan salary and salary advance

Transportation

Bonus for referrals

Childcare reimbursement

Learning platform

Service milestones/anniversary

Car lease support

Job summary

Quest Global is seeking a Configuration Engineer- Lead to join its medical devices team in India. You will oversee product configuration data management across lifecycle levels, ensuring data completeness, customer delivery continuity and high product quality.

The role requires extensive CAD-E/M tools expertise and collaboration with suppliers and internal stakeholders. Ideal candidates will have 8-12 years in configuration management, strong knowledge of IEC 60601 and global regulatory

Qualifications

• Completed engineering studies at University level; BE/BTech/ME/M-Tech in Mechanical, Electrical, Electronics Engineering or equivalent stream.
• 8-12 years of work experience in product configuration management.
• Expertise in CAD-E and CAD-M tools for data integrity purposes.
• Expert in data storage and transfer tools - e.g. Agile, Windchill SAP-PLM, SAP-IPPe, PDX, ODB++ etc.
• Expert in version control of TPD, CAD-E and non-volatile PL data.
• Experience in Transfer of data on PCBA’s and assemblies to and from relevant suppliers, including Engineering Change and End-of-Life issues.
• Experience in Medical Device development and knowledge of IEC 60601 standards will be an added advantage.
• Knowledge of Global Medical Quality and Regulatory Standards e.g. IEC, FDA, UL, CE, CSA etc. will be an added advantage.
• Disciplined team worker, ability to work independently.
• Highly structured and self-organized.
• Able to guide and mentor young engineers in the team.
• Result oriented team player.
• Ability to present and articulate ideas to key stakeholders and leadership team.
• Quality mindset in design and documentation.

Responsibilities

• Checking integrity of CAD-E, associated assemblies and CAD-M data.
• Transfer to suppliers: Exchanging data with suppliers.
• Interface between Philips and supplier for resolving DMR issues.
• Consulting on applicable standards, tools and assembly processes.
• Managing lifecycle of components, trigger actions for obsolescence risk mitigation.
• 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 users in data transfer and archiving.
• Assist in CAD-E tool validation.
• Based on specific EOL trigger, create relevant ECR and associated actions.
• Creating and maintaining documentation for tools used to support configuration management.
• Monitoring all configuration management processes.
• Providing the users, support and troubleshooting of issues, with the relevant configuration management software.
• Perform the role of Change Admin 1 and 2, for MR Therapy Products (also for overall MR systems in the absence of respective Configuration Designer).
• Conduct DCRB and OCCB meetings for MR Therapy Products (also for overall MR systems in the absence of respective Configuration Designer).
• Gather input from product configuration team in Best for MAXBOM changes in MR Therapy Products.
• Review of change notices of Therapy Hardware Team, Supporting the PMO for “Where Used” analysis of impacted parts etc.
• DCRB review.

Skills

8-12 years CM experience

CAD-E data integrity

CAD-M data integrity

Data storage & transfer tools

Version control: CAD-E & TPD

Data transfer to suppliers

IEC 60601 knowledge

Global Medical Quality Standards

Excellent communication

Mentoring teammates

Education

BE/BTech/ME/M-Tech in Mechanical, Electrical, Electronics or equivalent

Tools

Agile

Windchill

SAP-PLM

SAP-IPPe

PDX

ODB++

Job description

Job Requirements

You have the opportunity to be part of an exciting team and contribute to the design, development and maintenance of Medical Devices. In this role of Configuration Engineer- Lead, you are responsible for product configuration data management and completing appropriate data analysis across the lifecycle of overall system, sub-system and component levels to ensure completeness of data record, customer delivery continuity, and optimum level of products quality for our customers. This requires broad orientation, conceptual skills and a “can do” mentality, keeping abreast with all trends and advancements in technology.

Key Responsibilities

• Checking integrity of CAD-E, associated assemblies and CAD-M data


• Transfer to suppliers: Exchanging data with suppliers


• Interface between Philips and supplier for resolving DMR issues


• Consulting on applicable standards, tools and assembly processes


• Managing lifecycle of components, trigger actions for obsolescence risk mitigation


• 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 users in data transfer and archiving


• Assist in CAD-E tool validation


• Based on specific EOL trigger, create relevant ECR and associated actions


• Creating and maintaining documentation for tools used to support configuration management


• Monitoring all configuration management processes


• Providing the users, support and troubleshooting of issues, with the relevant configuration management software


• Perform the role of Change Admin 1 and 2, for MR Therapy Products (also for overall MR systems in the absence of respective Configuration Designer)


• Conduct DCRB and OCCB meetings for MR Therapy Products (also for overall MR systems in the absence of respective Configuration Designer)


• Gather input from product configuration team in Best for MAXBOM changes in MR Therapy Products


• Review of change notices of Therapy Hardware Team, Supporting the PMO for “Where Used” analysis of impacted parts etc.


• DCRB review

Skills and Qualifications

• Completed engineering studies at University level; BE/BTech/ME/M-Tech in Mechanical, Electrical, Electronics Engineering or equivalent stream


• 8-12 years of work experience in product configuration management


• Expertise in CAD-E and CAD-M tools for data integrity purposes


• Expert in data storage and transfer tools - e.g. Agile, Windchill SAP-PLM, SAP-IPPe, PDX, ODB++ etc.


• Expert in version control of TPD, CAD-E and non-volatile PL data


• Experience in Transfer of data on PCBA’s and assemblies to and from relevant suppliers, including Engineering Change and End-of-Life issues


• Experience in Medical Device development and knowledge of IEC 60601 standards will be an added advantage


• Knowledge of Global Medical Quality and Regulatory Standards e.g. IEC, FDA, UL, CE, CSA etc. will be an added advantage


• Disciplined team worker, ability to work independently


• Highly structured and self-organized


• Able to guide and mentor young engineers in the team


• Result oriented team player


• Ability to present and articulate ideas to key stakeholders and leadership team


• Excellent communication skills and Positive ‘can do’ attitude


• Quality mindset in design and documentation

Benefits at Quest Global

We believe that a comprehensive approach to employee benefits empowers your success at Quest Global. We pride ourselves on our multiculturality as a highly collaborative global engineering firm. With dedicated programs for employee appreciation, curated wellness programs for mental and physical health, and social volunteering support to empower you to give back to your community, we take a holistic approach to ensuring your experience at Quest Global prioritizes a good work/life balance.

Additional Benefits For Full-time Employees Include

• Group medical insurance coverage


• Group term life insurance coverage


• Group personal accident insurance coverage


• Staff loan salary and salary advance


• Transportation


• Bonus for referrals


• Childcare reimbursement


• Learning platform


• Service milestones/anniversary


• Car lease support

How we work: culture at Quest Global

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.