Lead Additive Manufacturing Engineer - Medical Devices

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

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.