Mechanical Design Engineer (Medical Device) - Labeling (R&D)

Quest Global; Maharashtra; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Quest Global in Pune is seeking a labeling engineer specialized in medical devices and consumer health products. The role focuses on designing and managing product labels, IFUs, and packaging artwork while collaborating with regulatory teams.

You will work from the Pune office, coordinating with cross-functional teams to translate labeling requirements into executable plans and ensuring compliance with global standards and internal SOPs.

Qualifications

• BE in Mechanical Engineering or equivalent degree.
• 2–4+ years of experience in labeling for Medical Devices / Home Appliances / Personal Health.
• Experience collaborating with multiple stakeholders and generate labeling requirements.
• Experience translating labeling requirements into a labeling plan for a project.
• Knowledge of IEC 60601 and IEC 6060335 standards for medical labeling is a plus.
• Proficiency with PLM systems and labeling processes.

Responsibilities

• Create and manage labeling for medical devices and packaging.
• Collaborate with regulatory functions to develop labeling for devices, packaging, and IFUs.
• Release labeling in PLM systems (Windchill, Teamcenter, Agile etc.).
• Create SOPs and Work Instructions for printing and applying labels.
• Support verification, validation, and quality compliance activities.
• Lead cross-functional teams on labeling design and project management.

Skills

Strong English communication

Cross-functional collaboration

Project management

Education

BE in Mechanical Engineering

MS in Engineering preferred / Equivalent

Tools

Windchill

Teamcenter

Agile

DOORS

NX CAD

Adobe Creative Suite

Bartender

Microsoft Project

Excel

PowerPoint

Word

Job description

Job Requirements

At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

Key Responsibilities

• B.E. in Mechanical Engineering / MS in engineering preferred / Equivalent Degree
• 2-4 or more years of experience in Design of labelling for Medical Devices / Home Appliances / Personal Health
• Experience of collaborating with multiple stakeholders and generate labeling requirements.
• Experience in translating the labeling requirements into a labeling plan for a given project.
• Collaborate with the regulatory functions to develop labeling for the device, packaging and IFU’s as required.
• Creation and change management of Product Labels, IFUs, Box Carton Artwork and Ancillary Labels.
• Managing and monitoring labeling documents and symbols
• Create Standard Operating Procedures (SOPs) and Work Instructions (WIs) for the printing and application processes of labels.
• Creation and change management of country-specific localization and distributor labeling.
• Release of Labeling in the PLM System (Windchill, Teamcenter, Agile etc.)
• Support Verification & Validation activities, Quality & Compliance and audits, and quality management labeling systems (CAPAs, NCRs, etc.)
• Support the First Article Inspection (FAI) activities for Labels.
• Lifecycle management and change control in product development environment (preferably experience with Windchill)
• Basic knowledge of paper types and their qualities
• Proficient in labelling and Graphic software (
• Adobe Creative Suite,
• Bartender,
• Lifecycle Sustenance engineering
• Basic Proficiency in NX CAD Software
• Preferred if possess knowledge and experience on interpreting and translating standards on IEC 60601 (medical electrical equipment) & IEC 6060335 (safety standard household equipment) into medical labelling requirements
• Experience with requirement management tools (preferably DOORS)
• Proven design engineering and project management experience leading cross-functional teams
• Experience supporting global projects.
• Demonstrated strong analytical and problem solving skills.
• Working knowledge of Microsoft Project, Excel, Power Point, and Word required
• Strong English written and verbal communication skills required

Note: This position is based out of Pune and the expectation is to be working from the office.

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.

Work Experience

• B.E. in Mechanical Engineering / Equivalent Degree
• 2-4 or more years of experience in Design of labelling for Medical Devices / Home Appliances / Personal Health
• Experience of collaborating with multiple stakeholders and generate labeling requirements.
• Experience in translating the labeling requirements into a labeling plan for a given project.