Mechanical Design Engineer (Medical Devices)

Quest Global; Maharashtra; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Quest Global is seeking a labeling engineer with 4–8 years of experience in design for medical devices and home appliances. The role involves translating labeling requirements into plans, collaborating with regulatory functions, and managing labeling documentation and systems.

The ideal candidate will have hands-on experience with Windchill/PLM tools, SolidWorks or Creo, and strong communication skills to coordinate with SQA, SCM, and manufacturing teams across global projects.

Qualifications

• B.E./MS in engineering with relevant labeling/medical device experience preferred.
• 4-8 years of experience in design/labeling for medical devices or home/healthcare equipment.
• Experience collaborating with multiple stakeholders and translating labeling requirements into plans.

Responsibilities

• Lead labeling design for medical devices and packaging.
• Develop labeling plans and ensure compliance with IEC 60601/6060335 where applicable.
• Create and maintain SOPs/WIs for labeling processes and tools.

Skills

Strong English communication

Project management

Cross-functional collaboration

Analytical problem solving

Documentation & SOP drafting

Presentation & persuasion

Education

B.E. Mechanical Engineering

MS in engineering

Equivalent Degree

Tools

Windchill PDLM

Solid Works

Creo

MS Office (Word, Excel, PowerPoint)

Minitab

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
• 4-8 years of experience in Design 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.)
• Lifecycle management and change control in product development environment (preferably experience with Windchill)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
• 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.
• Proficient with Solid Works, Creo, Microsoft Office suite software
• Knowledge of Parametric Modeling, GD&T, Tolerance Analysis, Solid Works experience preferred.
• Knowledge of Six Sigma DFSS Techniques
• Demonstrated experience with the design and qualification of injection-molded parts
• Experience with DFX
• Knowledge of Mathcad, LabView, or other Modeling Tools and experience
• Knowledge of DFMEA, PFMEA and other Risk Management Tools
• Knowledge of DOE, statistical analysis, and Minitab experience is preferred.
• Good Hands-on experience in the Windchill PDLM tool
• Identify the suitable material and create an EBOM.
• Knowledge of ISO13485 is preferred.
• Disciplined team worker, ability to work independently.
• Ability to present ideas and convince project team members.
• Be structured and self-organized.
• Excellent communication skills & project management skills
• Quality mindset in design and documentation
• Good documentation, Communication skill
• Familiar to Factory Environment & good RCA skill
• Work with different cross functional team such SQA, SCM, Manufacturing Engineer, Operations

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 world's 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 / MS in engineering preferred / Equivalent Degree
• 4-8 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.