Job Reference Number 22-MDPQDIV-14213

Classification APS Level 6

Job Title Engineer

Division Medical Devices and Product Quality Division

Branch Laboratories Branch

Section Biomaterials and Engineering Section

Location Fairbairn, ACT

Status Ongoing & Non-ongoing

Employment type Full-time & Part-time

Salary Range $88,439 - $99,772

Security Clearance Negative Vetting Level 1

Mandatory Qualifications A relevant degree in Engineering or Software Engineering is
required.

Contact Officer Name: Rebecca Moores
Phone: 02 6289 8825
Email: rebecca.moores@health.gov.au

Eligibility

• To be eligible for employment with the Department of Health and Aged Care

applicants must be an Australian citizen at the time an offer of employment is made

• An applicant’s suitability for employment with Health will also be assessed through a

variety of pre-employment check processes, such as:

• Satisfactory completion of an Australian Federal Police criminal history check,

and where relevant a Working with Children and Vulnerable People Check.

• Completion of a medical declaration and pre-employment medical (where

required).

• Providing evidence of qualifications.
  

Division Responsibilities

The Medical Devices and Product Quality Division is part of the Health Products Regulation

Group (Therapeutic Goods Administration) in the Department of Health. The division

monitors and tests the quality of medicines and medical devices approved for supply in

Australia and works to ensure Australian and international therapeutic goods manufacturers

meet specified standards.

Branch Responsibilities

The Laboratories Branch is responsible for post market monitoring and compliance testing,

investigations and reviews, as well as market authorisation assessment for therapeutic

goods.

The branch conducts laboratory testing in accordance with the laboratories testing program;

lot release; provides scientific expertise to assess technical data for marketing

authorisations; provides scientific and expert advice to internal stakeholders, committees,

government etc.; and participates in the development of standards and international

collaborative activities.

Section Responsibilities

The Biomaterials and Engineering Section supports public safety by undertaking desktop

evaluations and laboratory testing for medical devices that are marketed in Australia against

appropriate standards to ensure they comply with legislated requirements. Products may be

evaluated and/or tested in response to a device incident report and often relate to areas of

material science, biocompatibility, biomedical/electrical/mechanical engineering and more

recently, cyber security, electronics engineering and software engineering.

Key Responsibilities

The successful candidate will:

• Undertake engineering-based technical investigation of medical devices to ensure

they meet regulatory requirements, in line with the application of a risk-based

approach to regulation.

• Develop, deliver and analyse engineering-based testing projects for medical devices,

including preparing project proposals and testing plans.

• Prepare timely, high quality reports that summarise key issues, make

recommendations for regulatory decisions and provide rigorous technical analysis

and advice on the results of the investigation/analysis/testing and on the

implications of those results.

• Undertake peer review of reports created by other team members as required.

• Provide expert advice to the Assistant Directors of the Biomaterials and Engineering

Section and other staff in the Division

• Lead and contribute to innovation and continuous improvement activities in the

Section and Branch

• Develop and maintain knowledge of state-of-the-art equipment and test methods

and prepare proposals for the acquisition and use of new equipment.

• Maintain the high-quality output of the section by:

o Collaborating with other staff to ensure timely delivery of tasks

o Building team capability through collaboration with staff, including on

resource planning, work allocation, monitoring task completion and quality,

ensuring access to learning and development opportunities and by helping to

develop others.

o Contributing to and leading projects and initiatives within the Section, Branch

and Division.

o Contributing to a positive and collaborative workplace culture.

o Seeking opportunities to enhance technical and professional expertise.

Key Capabilities

The successful candidate will be able to demonstrate:

• A good understanding of engineering principles and a capacity to undertake

objective, critical analysis of engineering and regulatory issues, and to provide expert

advice on this basis, in line with a risk-based approach to regulation.

• Effective communication skills including written and oral presentation and reports.

• An ability to provide technical input and support for issues outside own area of

expertise.

• An innovative approach to problem-solving.

• An ability to work as part of a team to deliver results, even when priorities change.

• An ability to develop productive working relationships to identify opportunities and

facilitate cooperation.

Desirable Experience

• Experience working in a laboratory and/or in process automation and analysis

processes is highly desirable.

• Experience working under a quality management system, such as those defined in

ISO 9001 and ISO 17025 is desirable.

• A multi-disciplinary background is beneficial.

Application Response (Single page application)

Your application will be assessed on your ability to demonstrate that you possess, or have

the real potential to develop, the required skills, knowledge, experience and qualifications

to perform the role. These requirements are based on the information provided to you as

part of the job advertisement, in line with the APS Work Level Standards.

Applicants are required to provide a statement of claims framed around the key duties and

key capabilities. Your statement of claims should be no more than one page in total with a

font no smaller than size 10. Applications that do not meet these requirements may not

be considered.

Work Environment Description

Responsibilities – As detailed in Section 28 of the Work Health and Safety Act 2011 while at
work, a worker must:

• Take reasonable care for his or her own health and safety

• Take reasonable care that his or her acts or omissions do not adversely affect the

health and safety of other persons

• Comply, so far as the worker is reasonably able, with any reasonable instruction that

is given by the person conducting the business or undertaking to allow the person to
comply with this Act

• Cooperate with any reasonable policy or procedure of the person conducting the

business or undertaking relating to health or safety at the workplace that has been
notified to workers

• Complete all WHS related induction and training

• Report all work related incidents and/or illnesses to the WHS Section
  

Description Requirement Additional Information

Administrative

1. Computer Use Yes

2. Generic screen based Yes

3. Sitting at desk Yes

4. Standing for long periods Yes Laboratory work may

require standing for

extended periods.

Reasonable workplace

adjustments will be

considered.

Manual Handling

5. Lifting 0-15kg Yes

6. Lifting 15 kg + No

7. Climbing No

8. Bending Yes

9. Squatting No

10. Reaching Yes

11. Push/pull Yes

12. Sequential Repetitive No

Movements in short period of time

13. Manual dexterity/manipulation Yes

Work Environment

14. Work with others towards Yes

shared goals in a team environment

15. Works in isolation from other Yes

staff (remote supervision)

16. Distance walking (ie: Large Yes Transit between various

building or inter-building transit) laboratory areas and

desk/write-up areas is

Description Requirement Additional Information

required

17. Works outdoors No

18.Works in a call centre No

environment

19. Works in a customer service No

environment

Tasks Involving

20. Exposure to chemicals Yes

21. Exposure to biological hazards Yes Some positions may require

working in a PC2 laboratory.

22. Working at heights No

23. Requirement to wear personal Yes Relevant PPE is provided for

protective equipment (PPE) laboratory work.

24. Requirement for full Colour No

vision

25. Work with energetics and Yes Laboratory work may

explosives involve testing medical

devices that connected to

or equipped with an energy

source. Testing equipment

may also be connected to

or equipped with an energy

source.

26. Exposure to Petrol, Oil, Lubricant No

Products that may cause

dermatological conditions

27. Exposure to extreme No

temperatures

28. Confined spaces No

29. Exposure to Non-ionising Yes Laboratory testing may

radiation involve use of radiowaves,

infrared signals, WiFi and

Bluetooth channels.

30. Excessive Noise No

31. Low Lighting No

Description Requirement Additional Information

32. Dangerous Goods/ Equipment No

33. Exposure to airborne odours No

Travel

34. Frequent travel - Vehicle No

35. Frequent travel - Aeroplane No

36. Frequent travel - Seaborne No

Cyclic Workload

37. Peaks & Troughs No

38. Frequent Overtime No

39. Rostered Shift Work No