Product Development Engineer

Job Description

The Product Development Engineer is responsible for the design and development of products, improvement of existing product design and manufacture, and for development and subsequent transfer of manufacturing processes. Also key involvement in enquiry process. Conduct product and process changes in accordance with ISO 13485, ISO 14971, MDSAP, company procedures and any other relevant standards, regulations and customer requirements.

 

Key Responsibilities

  • Design & develop products and processes to deliver and support projects, in line with customer expectations and the required standards and regulations.
  • Deliver projects on time and to budget, ensuring MI3 and customer project procedures are followed.
  • Ensure the appropriate transfer of products from development to pilot production phase and on to full production phase conducting all agreed realisation activities.
  • Complete validation activities in line with Mi3 and customer requirements.
  • Owner of NC, CAPA and in root cause analysis of process and product NC and complaints, particularly when related to product design.
  • Provide technical support to Sales & Marketing team, where appropriate. Working directly with customers to discuss new projects and resolve design and process issues post-transfer.
  • Identify new technologies and products that could be utilised to facilitate the successful implementation of new products or to support future business needs.
  • Ensure timely escalation of issues to Line Manager and Quality where applicable.
  • For all tasks, make suggestions for continuous improvement of processes and implement where applicable / requested to do so.
  • Adhere to QMS, HSE policies and procedures and all other Mi3 policies and procedures at all times.
  • Perform any additional tasks as required by the job role from time to time.
Additional Responsibilities

For all tasks, make suggestions for continuous improvement of processes and implement where applicable / requested to do so.

  • At busy times reasonable requests may be made to perform duties of a similar nature
  • Provide cover for team members during periods of absence.
  • Adhere to QMS, HSE policies and procedures and all other Mi3 policies and procedures at all times.
Qualifications & Experience

Essential

  • Bachelor's degree or equivalent in a relevant Engineering or science discipline.
  • Previous experience with creation of 3D CAD and 2D Engineering drawings (SolidWorks or similar).
  • Previous experience of Design for Manufacture.
  • Knowledge of Standards Applicable to Medical Devices, covering but not limited to:
  • Risk Management (ISO 14971)
  • Quality Management (ISO 13485)
  • Awareness of Good Manufacturing Practice.
  • Awareness of plastics and metals for use in medical devices and tooling.
  • Awareness of MS Project and / or other Project Management techniques.
  • Familiarity with statistical methods.
  • Good skills in written and spoken English to enable communication with colleagues and to understand technical and QMS related documents.
What You'll Gain

The successful candidate joining the engineering team at Mi3 will be part of an exciting and dynamic operation bringing the medical innovations of our clients to life as well as being an integral part of our growth journey. In supporting our Commercial, Quality and Production teams you will personally develop your skills and experience across a wide range of different medical devices.

Location

The role is based at the Mi3 facility in Blackburn, Lancashire.

Salary

circa £35,000 depending on experience.

Benefits

25 days holiday plus bank holidays.

Pension contributions.

High Street Discounts.

Type of Contract

Permanent - 37.5 hours per week.

Start Date

As soon as possible.

Apply Now

To apply for this position, please email your CV and covering letter to jobs@mi-3.co.uk