Sustaining Engineer

To provide engineering input to ensure that changes required to released products to meet on-going business needs are conducted on time, within budget and with the required level of quality.

• Provide design and process development support to products post launch, coordinating design and manufacturing changes and improvements to meet defined device and manufacturing requirements
• Accept the introduction of new products and ensure their efficient ongoing transition into regular production by appropriate provision of engineering services to operations and quality
• Evaluate and document the feasibility, reliability and risk of changes to product designs and manufacturing processes.
• Through engineering analysis & testing demonstrate that engineering changes achieve product performance, manufacturability, safety, customer and regulatory requirements.
• Develop timelines and cost estimates for project tasks and appraise management of performance against plan to maintain compliance to project schedule
• Generate and review design history file documentation in compliance with GMP, QSR, ISO and company requirements throughout the project life cycle to ensure the design is fully documented
• Assessment of NCRs and implementation of agreed corrective / preventative actions to maintain regulatory compliance
• Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP).
• Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook.
• All other essential duties as directed.

Education / Qualifications:

Bachelor’s degree or equivalent (e.g. NVQ level 5) in an appropriate Engineering discipline or STEM equivalent; or

A Higher National Diploma/Certificate (HND/HNC) achieved through an apprenticeship programme in an appropriate Engineering discipline, with a minimum of 2 years' experience in a regulated industrial environment, preferably medical background but not essential.

Behaviours / Skills / Experience:

Passionate about getting things done and making things better

Ideally medical device design or manufacturing experience

Good working knowledge of MS Office applications (Word, Excel, Outlook, etc.)

Knowledge of mechanical design relating particularly to mechanisms

Knowledge of and ability to critique 2D engineering drawings and 3D modelling

Strong problem solving skills

Excellent verbal and written communication skills

Able to work as part of a team and meet project task deadlines

Experience of using process control tools i.e. control chart, pareto chart, cause and effect diagram

Knowledge of process deliverables particularly pFMEA, control plans, manufacturing plans and assembly aids (manufacturing work instructions)

Experience of process and equipment validation activities

Experience with using Minitab statistical software