Process Engineer
The primary role of this position is the design, implementation and validation of the processes required to produce implantable medical devices.
Summary about this job
Process Engineering
Company: Saluda Medical
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-2-2466-8335
Fax: +61-7-4910-1175
E-mail: n\a
Site: n\a
Detail information about job Process Engineer. Terms and conditions vacancy
- Opportunity to join a fast growing Australian medical device start-up
- Be a part of our innovation & technology
- Great work culture and supportive team
Saluda Medical is a start-up company whose aim is to develop advanced neuromodulation systems for the next generation of implantable neurostimulation devices. The primary role of this position is the design or improvement, implementation, and validation including maintenance of the processes required to produce Saluda’s active implantable medical devices.
Accountabilities and Associated Responsibilities:
- Responsible for the performing process validation activities, including tool validation;
- Responsible for ensuring processes continue to be capable of producing the required outputs with the required quality level;
- Responsible for addressing work instructions and ensuring they are of an appropriate standard.
- Identify Critical Process Parameters and design effective control systems;
- Train production operators and ensuring operators are able to consistently produce quality outputs;
- Ensure operator training records are up to date;
- Track and optimize yield and process capability;
- Contribution to risk documentation including pFMEAs;
- Ensure proper change management procedures are followed;
- Design and transfer of Tools/Jigs/Assembly aids;
- Responsible for ensuring all relevant tool records are up to date complete and accurate.
Essential Requirements:
- At least 3 years’ experience in process design, development and validation preferably in a highly regulated industry;
- Very good written and verbal communication skills;
- Bachelor's degree or higher in Manufacturing Engineering or equivalently relevant field;
- Strong problem-solving and leadership skills.
Desirable Requirements:
- Working knowledge of regulatory requirements;
- Experience in the Medical Device industry;
- Experience in the Neuromodulation industry.
- Experience in working within a controlled clean room environment