Mechanical Engineer - Additive Manufacturing and Medical Device Focus

MEKA INNOVATION PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

MEKA INNOVATION PTE. LTD. in Singapore is seeking a Mechanical Engineer to drive a medical device project that will spin off within a year.

The role emphasizes curiosity, willingness to learn, and a hands-on approach to solving hard problems. You will lead engineering efforts, conduct dFMEA/aFMEA, work with regulatory authorities, and coordinate with design and marketing to bring a quality product to market.

Qualifications

• Curious mind with willingness to learn, fail, and try again.
• Experience in mechanical engineering and additive manufacturing.
• Familiarity with medical device development and regulatory processes.
• Ability to lead engineering efforts for a medical device project.
• Knowledge of ISO 13485 quality systems is a plus.

Responsibilities

• Lead engineering for a medical device project from prototype to trials.
• Conduct dFMEA and aFMEA studies to support trials and market launch.
• Collaborate with regulatory consultants and authorities to obtain market clearance.
• Coordinate with design and marketing teams to optimize the product.
• Lead quality assurance in line with ISO13485.

Skills

Curiosity

Problem solving

Mechanical engineering

Additive manufacturing

Regulatory understanding

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.