Product Development Engineer

Essential Functions:

•  Bring together the expertise of healthcare professionals, colleagues, external sources as well as one’s own medical device knowledge to facilitate safe and effective design of orthopaedic products.

• Advances medical devices from concept through to clinical implementation using Design Control processes preparing product designs for commercialisation.

• Prepares and maintains Design History Files and related documentation appropriate for orthopaedic medical devices, ensuring that the design processes continue to satisfy the regulatory and quality requirements.

• Collaborates with cross functional teams (Manufacturing, Quality, Regulatory) to enhance device performance, durability, manufacturability and cost-effectiveness.

• Initiate test programmes, reviews and summaries of data in support of product design, regulatory submissions, manufacturing, quality, and sales.

• Initiate, coordinate and review external laboratory testing of company products or related support activities.

• Prepare and update project schedules and co-ordinate product programs.

• Work with appropriate legal/patent officials, as required, on patent or IP matters.

• Review surgical/study/PMCF feedback and consolidate the knowledge within the technical files as appropriate.

• Provide product development support in designs of processes, tooling, inspection, and production facilities.

• Provide product technical support and documentation for marketing, HCP’s, manufacturing, quality, and sales.

• Travel as required, for professional meetings or in association with product development or technical support activities.

Qualification

• Bachelor’s degree in Mechanical Engineering, Biomechanical Engineering, Engineering Mechanics or other related engineering field plus a minimum of two (2) years of experience in orthopaedic product development or related field.

  
  

Preferred Experience:

• Proficient utilising design and development tools including CAD (SolidWorks), systems.

• Track record of designing medical devices, successfully translating concepts to clinical implementation.

• Strong understanding of processes and methods used in Orthopaedic Device manufacturing.

• Able to comprehend and process data outputs from testing activities, studies and research.

• Strong problem-solving skills.

Demonstrated ability to work independently, in teams, and with external collaboration partners.

Ability to influence, communicate, and collaborate in teams spanning multiple time zones as part of a global organisation.

Good understanding of the quality systems and regulatory requirements for Medical Devices.

Excellent written and oral communication skills

Detail oriented with strong documentation skills.