Production Engineer

mexec; Melbourne; On-site; AUD 130,000 - 155,000; Full time

Job summary

A leading company in microscopic imaging is seeking a Production Engineer to develop efficient manufacturing processes for new medical devices. This role involves collaboration with design teams, process documentation, and ensuring compliance with quality management systems. The successful candidate will contribute to innovative solutions that enhance patient care and clinical decision-making.

Qualifications

• At least 3 years’ experience in a manufacturing environment.
• Strong understanding of medical device industry.

Responsibilities

• Develop safe and efficient manufacturing processes.
• Collaborate with design and engineering teams.
• Identify opportunities for process improvements.

Skills

Communication

Collaboration

Education

Bachelor’s degree in engineering

Tools

ISO 13485:2016

ISO9001

Job description

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Our client is a global leader in microscopic imaging, with patented technologies enabling in vivo imaging of tissues across a wide range of surgical and research applications. Through innovation and collaborations locally and internationally, they are expanding their portfolio and will transform patient’s lives by enabling digital biopsies for cancer screening, diagnosis, and treatment.

The Opportunity

Reporting to the Chief Technology Officer, you will develop safe and efficient manufacturing processes to transfer new medical devices to the production stage:

• Collaborate with design and engineering teams to facilitate the transition from product development to manufacturing, with a focus on DFM.
• Work with stakeholders during product development to transfer designs to safe and efficient manufacturing processes.
• Develop, review, and maintain manufacturing documentation, including work instructions, standard operating procedures (SOPs), and assembly guides.
• Prepare and maintain document packages including BOMs, work instructions and assembly drawings for manufacturing.
• Identify opportunities for process improvements and implement solutions to enhance production efficiency and product quality.
• Support manufacturing by conducting root cause analysis, identifying solutions and introducing process improvements.
• Perform verification and validation of manufacturing processes, including equipment qualification and process validation.

The Requirements

• A bachelor’s degree in engineering (mechanical, mechatronic, manufacturing or similar field).
• At least 3 years’ experience post-graduation in a manufacturing environment, preferably in the medical device industry.
• Strong understanding and/or prior experience in the medical device industry and/or working under ISO 13485:2016, ISO9001 or similar quality management systems.
• Familiarity with design for manufacturability (DFM) principles and experience applying them in product development.
• Excellent written and verbal communication skills with the ability to collaborate effectively with relevant stakeholders.
• Knowledge of electronic circuits and experience in software scripting will be advantageous.

The Offer

The successful candidate will join a team of experts developing cutting edge products to improve clinical decision making and positively impact patient’s lives. Please email any questions you may have to [e-mail] or call 1300 063 932 to arrange a time for a confidential discussion with Mark Thomas or Marilyn Jones. To apply, please visit www.mexec.com and click Apply Now to submit your current CV and cover letter.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science and Engineering

• Industries

  Biotechnology Research and Medical Equipment Manufacturing

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