Job Role -

Mechanical Engineer & Quality Executive

Job Location -

Work from Office, Mumbai

Job Type -

Full Time

Experience -

2 - 3 Year

Salary -

Best in Industry

Qualification -

Bachelors/Masters in Mechanical Engineering

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Job Brief An incredibly rare opportunity for an Engineer to join a well-funded early-stage MedTech startup and outstanding team. Prototype and subsequent MVP both have blockbuster results, targeting an immediate million-dollar market, enabling tremendous value creation in a short time for a strong technologist having an entrepreneurial attitude. We are looking for a passionate technologist with scaled MedTech experience for a once-in-a-lifetime opportunity to lead a medical device start-up with both a mission and tremendous value creation upside. The ideal candidate would be involved in the full development lifecycle of products, subsystems, modules, and platforms, from concept to detailed design, prototyping, testing, validation, and transfer to production. You will be responsible for the delivery of several subsystems which will be a part of a complex electromechanical surgical device for the medical industry and for transitioning the new product development from pre-commercialized to commercialized and deployment at scale.

Responsibilities of Mechanical Development

- Leading the product design and development of a surgical device in the electro-mechanical domain. Independently research, design, develop, modify and verify components, modules, and subsystems for medical devices.





- Work on mechanical design & development in CAD environment, preferably in Solidworks.
- Prototype the developed designs , collect and maintain the data Documentation of device development in compliance with ISO 13485
- Validation and Testing of the device.
- Documentation and quality control.
- Finding the solution for device breakdown, & troubleshoot the device at deployed locations pan India.Electromechanical development, testing experience & assembly QC for pilot batches for small size.

Responsibilities of Quality Control

- Implementing and maintenance of Quality Management systems for medical devices based on ISO 13485.
- Understand QMS flow, SOPs and implement those in product development & testing activities
- Documentation of the SOPs, policies, and record-keeping
- Internal audits – planning, conducting, continuous improvement
- External audits – Liaoning with notified bodies, regulators, customer audits, supplier audits
- Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
- Assists the departments in the development of SOPs to ensure regulatory compliance

Requirements

- Should have knowledge of mechanical engineering.
- Should have experience in defining SOPs for the design process, standard parts selection, BOM management, testing, and validation.




- Prefer to have knowledge of compliance regulations and standards, including ISO 13485, ISO 14971 for CDSCO Approval throughout the design and development process. Also, positive to have experience in generating and maintaining the documentation as per QMS and project management.
- Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
- Bachelors/Masters in Mechanical Engineering.
- Entrepreneurial mindset – Can-do attitude and Excellent communication skills.

About Us: Pacify Medical is an award-winning medical device startup developing portable surgical devices. The startup aimed to revolutionize skin transplantation surgery through the innovative technology of spraying skin thereby advancing the standard of care for large wounds that significantly reduce the surgery time and skin requirements, resulting in rapid healing and shorter hospitalizations. It is currently incubated at SINE, IIT Bombay, Powai, Mumbai.

We are a team of engineers from IIIT and supported by MIT USA, BIRAC, COEP Pune, and BETIC IIT Bombay.

Why you should join us?

What makes us different is the way we take up challenges and a solution-driven, go-getter approach. We have a result-oriented work culture and have a brilliant young team with people from IITs, IIITs, and other top colleges. With all this, we have seen exponential growth in the last 2 years.

To strengthen our Mechanical Design team, we are looking for passionate people who are looking for challenging opportunities to work on building medical device industry-leading products. To learn more, please visit www.pacifymedical.com and our career page: https://bit.ly/3yATw0v

📌 Mechanical Engineer & Quality Executive (Mumbai)
🏢 Pacify Medical Technologies
📍 Mumbai