Mechanical Engineer - Additive Manufacturing and Medical Device Focus

Meka Innovation Pte Ltd; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Meka Innovation Pte Ltd in Singapore is seeking a talented Mechanical Engineer to join our team, focusing on a medical device that will spin off from the company within 1 year.

You will lead engineering for the device, perform DFMEA and AFMEA studies to aid in trials and market launch, and work with regulatory consultants and authorities to bring the product to market. You will also collaborate with design and marketing to create the best possible device while upholding ISO13485 quality.

Qualifications

• Experience leading engineering for medical device projects.

Responsibilities

• Leading engineering for a medical device project - validated prototype, building product for trials
• Conduct dFMEA and aFMEA studies to aid in trials and market launch
• Work with regulatory consultants and authorities to get product to market
• Work with the design and marketing team to develop the best product possible
• Lead quality assurance - ISO13485

Skills

Mechanical engineering

Leadership

DFMEA

AFMEA

Regulatory knowledge

Additive manufacturing

Medical devices

Tools

ISO 13485

Job description

We are looking for a talented Mechanical Engineer to join our team. You will be working on a medical device that will be spinning off from the company within 1 year.

We need people who are looking to work hard and push boundaries.

One of the most important attributes we look for in a colleague is curiosity. You must look at the world with a curious eye and look for problems to solve. And you must try to go solve them, even if they are out of reach. You must be willing to learn, fail and try again. A lot of our work is centered around exploration and a curious mind is a must. You must be comfortable working with foreign concepts that are very far out of your comfort zones. Let's say, nothing is beneath you. You will be tasked to do whatever it takes to get the job done.

Your responsibilities include:

• Leading engineering for a medical device project - validated prototype, building product for trials
• Conduct dFMEA and aFMEA studies to aid in trials and market launch
• Work with regulatory consultants and authorities to get product to market
• Work with the design and marketing team to develop the best product possible
• Lead quality assurance - ISO13485

You need to be well-versed in the mechanical engineering, additive manufacturing and medical device world. This would be your playground.