Process Development Engineer in London

The process development engineer plays a critical role within NPI & Manufacturing both at ATL‐UK & Globally. As part of the NPI team, the primary function is to assess new project requirements from a process perspective. The engineer conducts DFM/DFA and transfers that information, enabling the design, development and optimisation of processes for producing goods. Additionally, the role may require improving existing processes to enhance efficiency, quality and cost-effectiveness, meeting the company's standards to ensure safe production of medical devices.

Key Responsibilities

• Process Design: Design, develop, implement and maintain assembly processes, including line set‐up/layout, equipment identification and allocation, jigs and fixtures, data collection and analysis to ensure smooth and continuous operation and facilitate the transfer from NPI to production.
• Process Technology and Innovation: Evaluate new projects in relation to processes and manufacturing, drive continuous improvement and innovation, stay current with the latest advancements in medical technology and process engineering, and share expertise to strengthen the team and business.
• Validation: Develop processes that comply with Good Manufacturing Practice (GMP) and other quality system documentation requirements to support NPI and development.
• Documentation: Prepare manufacturing documentation, technical reports and presentations to ensure the smooth transition into manufacturing (internal and external) and maintain a record of all documentation, including drawings, sketches, calculations and records.
• Continuous Improvement: In collaboration with other ATL‐UK functions, assess process methods to minimise process time and scrap; maintain and improve customer quality, output, and equipment maintenance; analyse data to justify capital expenditure.
• Health & Safety (H&S): Comply and work within all current H&S rules and guidelines, ensuring all developed processes meet the highest health and safety standards.
• 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).
• Other: Perform all other essential duties as directed.

Qualifications And Skills

• Education/Qualifications: HNC or Degree in Mechanical Engineering, Mechatronics or related field.
• Behaviours/Skills/Experience: Good communication skills and the ability to plan, execute and manage tasks within budget and on schedule. An understanding of medical manufacturing processes, technologies and equipment. An understanding of sterile manufacturing and cleanroom protocols. Experience in mechanical design for manufacture, CAD (SolidWorks), fixture design, new product introduction and manufacturing support and improvements. Experience with process control tools and improvement techniques. Strong analytical skills to identify and resolve process issues efficiently. Good understanding of various joining and assembly techniques. Line balancing. Lean manufacturing. Proficiency in data analysis to monitor process performance and identify areas for improvement. Ability to read and understand technical drawings, awareness of tool room shop processes and beneficial geometrical tolerances. Excellent team player with a willingness to lead and drive process tasks forward to meet project timelines. Adaptability to changing project requirements in a fast‐paced, dynamic environment. Computer literate with knowledge of the Microsoft Office suite. Acts with integrity and takes accountability for accuracy and quality of work. Understanding and delivering internal/external customer focus. Knowledge of regulatory requirements and standards (e.g., FDA, MDR, EMA, ISO 13485). Ability to communicate and present at all levels within the business, including engineering‐to‐engineering technical discussions.

Benefits

• Bonus: Up to 10% of annual salary, dependent on achievement of financial measures (terms and conditions apply).
• Pension: Company puts 10% of salary into pension; employee contribution is optional and may be made through salary sacrifice.
• Holidays: 25 days holiday plus 8 bank holidays (33 days).
• Sick Pay: Company sick pay aligned to the contractual notice period.
• Private Health Care (PMI): Company covers basic membership cost with BUPA (benefit in kind, taxable). Family may be added for a small cost.
• Life Assurance: 4 x salary.
• Reward Gateway: Online benefits portal offering discounts/cashback on retailers, gym memberships, mobile phones.
• Learning & Development: Support for development through bespoke training, leadership development and further education opportunities.
• Hybrid Working: Ability to work between office and home as defined by business needs.
• Employee Assistance Programme: 24/7 helpline.
• Dental Cover: Cashback on check‐ups and treatments, cover for oral cancer, injury and emergencies, worldwide cover.