Mechanical Engineer. Medical Device Project.

 

North Sydney Location.

Medical Device Manufacturing.

R&D, Testing, Lab Reports, FDA Documentation.

My client is in the late stages of gaining approval for their medical device in Australia and the US.

They are seeking to employ a Degree qualified and experienced Mechanical Engineer who is has an understanding of specific requirements of the Medical Device Industry here in Australia and the US. Ideally you will already have had at least five years in this field and be able to commit to a long term contract or Permanent role in order to assist the company in bringing their product to market.

•  An understanding and knowledge of medical device mechanical regulatory requirements.
• Ensuring ????? ????? and systems comply with all regulatory and quality system requirements
• Able to carry out system specifications, verification and validation documentation, FDA Documentation, reporting etc
• Experience with ProE would also be an advantage.

 

This is a hands on role working within a team of dedicated professionals. Your skills as a Mechanical Engineer, technical writer, ability to deliver on project, lab reports, documentation etc in this highly regulated industry will be well rewarded.

 

Please apply in confidence via the link.