Company Description:

Bioscan Research is an award-winning MedTech company developing innovative optical and AI-enabled medical devices for the early detection and monitoring of neurological disorders. Our flagship product, CEREBO®, is a portable, non-invasive device for the rapid detection of intracranial haemorrhage and is being deployed across hospitals and emergency care settings. With multiple granted patents, ISO 13485 certification, and a growing portfolio of next-generation products, Bioscan is advancing technologies in neurodiagnostics, patient monitoring, and clinical decision support.

Role Description:

This is a full-time, on-site Mechanical Design & Production Engineer role based in Ahmedabad. The engineer will be responsible for the mechanical design, development, prototyping, manufacturing, and continuous improvement of Bioscan Research's medical devices. The role spans the complete product lifecycle—from concept development and opto-mechanical design to production engineering, design transfer, and post-market design improvements. Working closely with electronics, optics, firmware, software, quality, regulatory, clinical, and manufacturing teams, the engineer will ensure that products are reliable, manufacturable, serviceable, and compliant with medical device standards.

Key Responsibilities:

-- Mechanical Design & Product Development

- Design and develop mechanical assemblies, enclosures, fixtures, and opto-mechanical systems for Bioscan's medical devices and next-generation products.
- Create creative mechanical concepts for handheld devices, monitoring systems, wearables, and accessories.
- Design for manufacturability, assembly, serviceability, reliability, and cost-effectiveness.
- Prepare 3D CAD models, engineering drawings, GD&T;, BOMs, and design documentation.
- Perform tolerance analysis, material selection,



structural and thermal analysis, and prototype development.
- Design rugged products for hospital, ambulance, industrial, military, and field environments, considering temperature, humidity, dust, vibration, shock, and transportation.
- Develop enclosures to achieve target Ingress Protection (IP) ratings through appropriate selection of materials, seals, gaskets, coatings, and fastening methods.
- Evaluate and refine designs through prototyping, environmental testing, and iterative design improvements to ensure long-term product robustness.

-- Opto-Mechanical Development

- Collaborate with optical engineers to design optical probe assemblies, sensor housings, alignment mechanisms, and light-guiding structures.
- Develop precision mechanical solutions for optical component integration and alignment.
- Optimise probe ergonomics, environmental protection, and robustness for clinical use.

-- Production Engineering

- Support pilot production, production scale-up, and manufacturing process development.
- Develop assembly procedures, work instructions, tooling, fixtures, and jigs.
- Improve manufacturing efficiency, yield, and product quality.
- Coordinate with suppliers and manufacturing partners for component development and production.

-- Verification & Validation

- Plan and execute mechanical verification testing, environmental testing, drop testing, ingress protection, usability evaluations, and reliability studies.




- Investigate product failures and implement corrective and preventive design improvements.
- Support design verification and validation activities throughout the product lifecycle.

-- Regulatory & Documentation

- Prepare and maintain design documentation in accordance with ISO 13485 and medical device design control requirements.
- Support Design History Files (DHF), Device Master Records (DMR), Design Inputs/Outputs, Design Reviews, Risk Management, Verification & Validation reports, Engineering Change Orders (ECOs), and Design Transfer documentation.
- Collaborate with Quality and Regulatory teams to support CDSCO, FDA, CE MDR, and other regulatory submissions.

Skills & Experience

- Ability to work in a multidisciplinary R&D; environment and manage multiple development activities simultaneously.
- Bachelor's or Master's degree in Mechanical Engineering, Mechatronics Engineering, Product Design, or a related discipline.
- 2–5 years of experience in mechanical product design, production engineering, or medical device development.
- Strong proficiency in SolidWorks, Creo, Fusion 360, or equivalent 3D CAD software.
- Experience in sheet metal, injection moulding, machining, 3D printing, silicone components, and precision mechanical assemblies.
- Understanding of Design for Manufacturing (DFM), Design for Assembly (DFA), tolerance analysis, and material selection.
- Experience in prototype development, production engineering, and manufacturing process optimisation.
- Familiarity with opto-mechanical systems or precision instrument design is highly desirable.
- Knowledge of ISO 13485, medical device design controls, risk management, and engineering documentation.
- Strong analytical, problem-solving, communication, and project coordination skills.

📌 Mechanical Design & Production Engineer (Ahmedabad)
🏢 Bioscan Research
📍 Ahmedabad