Job Description

Job Responsibilities

Lead projects in design and development of medical systems on time and on budget.

Manage the creation of key design and development documentation that meets quality and regulatory requirements.

Work closely with a multidisciplinary team (such as R&D, Manufacturing, Service, Clinical, Quality, Regulatory and Marketing departments)

Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.

Manage GMP systems, including production quality assurance procedures, pre-clinical testing programs and post-production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.

Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and international regulations.

Requirements:

Minimum of Bachelor's in engineering (Mechanical, Electrical or Systems preferred).

Minimum of 5 years in medical device project management required.

Experience managing projects for European CE Mark, China NMPA and US FDA is preferred.

Experience with Design Control procedures and requirements engineering.

Experience developing systems in compliance with IEC (62304, 60601) and other industry standards for electronic medical device equipment is preferred.

We would like to invite interested applicants to apply.

Anna Wee

Registration No: 12C6253

License No: R22108919

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Additional Information

Career Level

Manager

Qualification

Bachelor's Degree, Post Graduate Diploma, Professional Degree

Years of Experience

5 years

Job Type

Full-Time

Job Specializations

,

Company Overview

Connecting talents . Driving dreams

Dynamic Human Capital connects talents to earnest employers who are serious about taking steps to grow together. Working closely with esteemed organizations, we unearth potential gems for each client's recruitment needs.

What we do

Our experience and specialization take us through scores of potential human resources that could be that instrumental player in your organization. As strategic advisors, our goal is to suss out the right personnel to be the right fit in diverse industries.

We pride ourselves with a seamless approach to facilitate the pursuit of individuals who are serious about their career.

Additional Company Information

Registration No.

201228584R

EA No.

12C6253

Company Size

1 - 50 Employees

Average Processing Time

6 days

Industry

Human Resources Management / Consulting