Mechanical Design Engineer

Innaccel; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

InnAccel seeks a Mechanical Design Engineer to support design and engineering solutions for medical device products. Under mentorship, you will deliver design iterations, perform risk retirement, and verify designs using first principles and GD&T.

You will learn InnAccel’s stage-gate product development system and help transfer designs into manufacturing. Expect to work cross-functionally, develop prototypes, author technical documents, and ensure regulatory compliance with ISO13485, ISO14971,

Qualifications

• 4-year engineering degree required (Mechanical, Industrial & Production or Materials).
• 3+ years of experience leading/supporting product development projects in medical device, Aerospace, Robotics or similar high precision industry & Mechanical design using CAD/CAE, in metals and plastic.
• Exposure to CAD/CAE tools (Solidworks preferred).
• Exposure to ISO13485, ISO 14971, EUMDD, EUMDR & FDA is required.
• Experience with implementing product changes (ECR/ECO) through a structured, phase-gated, product development process is desired.
• Good understanding of medical device product development risk management methodologies (EURA, FMEA, etc.).
• Demonstrated first principles engineering and design skills (CAD/CAE).
• Ability to analyse, organize and present large amounts of data in a clear and concise manner.
• Disciplined, detailed and well organized with managing documentation in a regulated environment.
• Ability to execute concurrently multiple projects and manage priorities.
• Ability to work independently as well as delegate appropriately.

Responsibilities

• Assist design and engineering solutions for medical device products.
• Deliver design iterations and verification using first principles.
• Learn InnAccel’s stage gate Product Development System and use relevant engineering tools.
• Collaborate cross-functionally to execute all aspects of product development.
• Ensure successful design transfer into manufacturing.
• Write technical documents and perform prototyping/testing as needed.
• Support risk analysis and verification/validation activities.

Skills

Solid 3D CAD modeling

Drawing for manufacturing

GD&T fundamentals

Failure mode analysis

Risk analysis

Product design & development

Test method setup

Prototype development

Documentation writing

Communication skills

ISO13485 knowledge

NPD processes

Six Sigma green belt

FMEA

Change Control / ECR/ECO

Project management

First principles engineering

Education

4-year engineering degree (Mechanical, Industrial & Production or Materials)

Tools

Solidworks

Job description

InnAccel is India’s first MedTech innovation platform, developing novel products for critical unmet healthcare needs in India and global emerging markets. InnAccel is creating the world’s first portfolio of medical products designed, engineered, and priced for emerging markets. Our goal is to transform healthcare, sustainably and profitably, in India and the world.

We are looking for driven team members who are motivated to work in an exciting, high-growth, entrepreneurial environment.

Position Title

Mechanical Design Engineer

Reports to

Director, Design and Manufacturing

Location

Bangalore

Role Overview

The Mechanical Design Engineer will assist the design and engineering solutions for medical device products. (S)he, under the mentorship of a lead/principal engineer, will deliver relevant solutions to new and existing products through design iterations, risk-retirement using first principles engineering, technical analysis and verification of the design. The Design Engineer will learn and utilize InnAccel’s stage gate Product Development System and use relevant engineering tools to deliver a high quality, robust and cost-effective design and will partner cross-functionally to execute all aspects of product development. They will also ensure successful design-transfer into manufacturing.

Note

This is an immediate opening, and selected candidates are expected join in short notice.

Skills and Requirements

• Strong engineering fundamentals and hands‑on engineering skills
• Experience in hand calculations
• Solid 3D CAD modeling skills (Solidworks)
• Generation of Drawings for manufacturing (DFM)/BOMs
• Solid GD&T fundamentals
• Experience in Failure mode analysis
• Experience in risk analysis, preferably hands on experience in making Risk management file
• Good Product Design & Development Experience preferably for medical devices
• Concept designing and development/ Problem Solving Skills
• Ability to set up new test methods, verification and validation
• Design JIG and Fixture
• Performing Design and Process Validation
• Prototype Development and Testing
• Writing technical documents
• Excellent verbal and written communication skills
• Awareness about ISO13485, ISO14971 and International standards, and norms
• Knowledge of Change Control Procedures and NPD Processes
• Six Sigma methodologies, preferable green belt certified
• Basic understanding of FEA
• Basic understanding of ISO, CE and FDA quality and certification systems

Qualifications

• A 4-year degree in a relevant engineering field is required (i.e. Mechanical, Industrial & Production and Materials Engineering)
• Minimum 3 years of experience leading / supporting product development projects in medical device, Aerospace, Robotics or similar high precision industry & Mechanical design using CAD/CAE, in metals and plastic.
• Candidates with prior experience in Medical Devices, Pharmaceuticals, Petrochemicals, Aerospace, Automotive and Robotics will be preferred.
• Exposure to CAD/CAE tools (Solidworks preferred).
• Exposure to ISO13485, ISO 14971, EUMDD, EUMDR & FDA is required.
• Experience with implementing product changes (ECR/ECO) through a structured, phase-gated, product development process is desired.
• Good understanding of medical device product development risk management methodologies (EURA, FMEA, etc.).
• Demonstrated first principles engineering and design skills (CAD/CAE).
• Ability to analyse, organize and present large amounts of data in a clear and concise manner.
• Disciplined, detailed and well organized with managing documentation in a regulated environment.
• Ability to execute concurrently multiple projects and manage priorities.
• Ability to work independently as well as delegate appropriately.