Manufacturing Engineer
Seeking a Manufacturing Engineer to join our leading innovative organisation. Be part of a dynamic work environment & be part of a great team!
Summary about this job
Production, Planning & Scheduling
Company: Nanosonics Limited
Location: Sydney
Work type: Full Time
Salary: n\a
Phone: +61-2-6409-5780
Fax: +61-7-3524-3953
E-mail: n\a
Site: n\a
Detail information about job Manufacturing Engineer. Terms and conditions vacancy
Nanosonics Limited is a publically listed ASX200 Australian medical device company. We develop, manufacture and commercialise innovative and unique medical device disinfection solutions for global markets.
Our Company's mission is to improve the safety of patients, clinics, their staff and the environment by transforming the way infection prevention practices are understood by introducing innovative technologies that deliver improved standards of care.
We are currently expanding our operations both domestically and globally and we are seeking a Manufacturing Engineer to join our Company on permanent full-time basis.
What you will be doing:
Support production activities to ensure Nanosonics products are delivered to market on time, and meet quality and cost requirements:
- Conduct and document non-conformance investigations / root cause analysis / DOEs
- Manage/assist in Change Note implementation,
- Create and maintain tool specifications, qualification protocols and reports.
- Scheduled service and maintenance of production equipment
Plan, co-ordinate and monitor continuous improvement and cost saving initiatives:
- Manage/Assist in manufacturing work flow design and production layout
- Coordinate manufacturing engineering activities for verification and validation builds
- Perform Process and Equipment Validation
Manage Production activities to ensure compliance with ISO 13485 and all other regulatory requirements:
- Generate and maintain manufacturing documentation required by ISO13485 and FDA, QSR. Maintain EN ISO 13485 QMS documentation
- Work closely with Production staff, Contractors, and External Suppliers to ensure compliance to our QMS.
Oversee NPI activities and coordinate changes from Product Development to Manufacturing:
- Provide DFM/DFA/DFT/PFMEA and input to product design
- Provide input for short and longer term manufacturing requirements, component tooling, manufacture, test and assembly
- Establish manufacturing processes for new products
- Verify and validate manufacturing process.
The qualifications, experience & skills necessary to succeed in the role...
- Tertiary qualification in an engineering discipline with a minimum of 2 years' experience in a commercial manufacturing environment, preferably electromechanical assemblies in medical device environment or similar regulated industry.
- An understanding of continuous improvement processes
- Experience in designing and performing process validations and equipment qualification is desirable.
- Strong analytical skills with emphasis on a scientific method of problem solving, coupled with a common sense approach and the ability to produce good documentation
- Ability to multi-task and prioritize responsibilities to ensure deadlines are met in a fast-paced environment.
- Motivated self-starter, able to work individually and as part of a team, with a 'go the extra mile' attitude to complete work well.
To submit your application, please apply online using the appropriate link below.
**No Agencies thank you, we have this role covered**