Senior Safety Regulation Engineer

In this role, you have the opportunity to

The Senior Safety Regulation Engineer is to own product safety design and regulation compliance.

The Senior Safety Regulation Engineer is to provide technical support help Regulatory Affairs Engineer finish product regulatory registration with in-depth knowledge of products and standards.

You are responsible for

• Break down safety and regulatory requirement such as IEC/UL/CE/FDA/NMPA as well as other regulators in worldwide into the design specification requirement.

• Cooperate with external NRTL lab such as TUV to finish system type test and get TRFs.

• Be responsible of the system regulatory technical document, such as PTR, GSPR.

• System ECO design, such as EUROHS, REACH and China ROHS.

• System label design.

You are a part of

A progressive and energetic team that contributes directly to the growth of the business. You have a direct reporting line to the Manager of DXR system engineering with Cross-functional team as your key stakeholders.

To succeed in this role, you should have the following skills and experience

• All applicants are required to have the following:

• Have an advanced understanding about IEC60601 series including EMC or equivalent standards.

• Have advanced hardware knowledge either in electronics and control system or in mechanical system.

• Be able to specify clear technical requirements according to the IEC standard input.

• Must have excellent both Mandarin and English communication & negotiation skills (spoken, written and presentation).

• Although not essential, it would be desirable if applicants have the following:

• Bachelor’s Degree in Engineering or related field required. Master’s Degree preferred.

• 1-3 years of experience in medical device hardware design and approbation work.

• Good teamwork spirit and soft skill; be able to drive and solve problem in efficient way.

• Familiar with ISO14971, ISO 13485, ISO17025 standard.

• Understand the matured industry product development process

• Background of Medical devices (DXR) is preferred.