Process Development Engineer

Position Summary

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. To conduct DFM/DFA and transfer that information, enabling the design, development and optimisation of processes for producing goods. In addition, there may be the requirement to improve 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. – Not limited to: 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 for continuous improvement and innovation in process development. Staying up to date with the latest advancements in medical technology and process engineering. Share expertise and experience to strengthen the team and business.

• Validation:  Ability to develop processes that comply with Good Manufacturing Practice (GMP), process validations and other quality system documentation requirements to support NPI and development.

• Documentation:  Prepare manufacturing documentation, technical reports and presentations etc, to ensure the smooth transition into manufacturing (internal and external). Maintain a record of all documentation, including drawings, sketches, calculations, records etc. ensuring a full history of process and product evolution is documented.

• Continuous improvement:  In collaboration with other ATL-UK functions, assess process methods to minimise process time and scrap; maintain and improve the customer quality, output and equipment maintenance and assist with implementation, where appropriate.  This will include processes to measure, analyse and improve the efficiency and yield of current equipment, using data gathered to establish optimum capability of current machinery and to justify any capital expenditure required.

• Health & Safety (H&S):  Comply and work within all current H&S rules and guidelines, ensuring that all developed processes comply with the highest standards of health and safety.

• 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.

• Other:  All other essential duties as directed.

Qualifications and Skills

• Education/Qualifications:  HNC or Degree in Mechanical Engineering, Mechatronics or related field

• Behaviours/Skills/Experience:  All activities will require 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 areas like sterile manufacturing and cleanroom protocols

• Experience of Mechanical Design for Manufacture, CAD (SolidWorks), Fixture design, New Product Introduction and Manufacturing support and improvements

• Experience of using 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 and understanding of tool room shop processes - geometrical tolerances would be beneficial

• Excellent team player with a willingness to take the lead and drive process tasks forward to meet project timelines

• Ability to adapt to changing project requirements, with the flexibility to work in a fast paced dynamic environment

• Computer literate with knowledge of the Microsoft office suite

• Acts with integrity; 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 with external customers, often engineer to engineer technical discussions

Benefits

Bonus

Up to 10% (of annual salary) bonus - dependant on achievement of financial measures (terms and conditions apply)

Pension

Company put 10% of salary into pension, there is no obligation for employee to contribute but can do under salary sacrifice. 

Holidays

25 days holiday plus 8 bank holidays (33 days). 

Sick Pay

Any Company sick pay is aligned to the contractual notice period

Private Health Care (PMI)

Current provider is BUPA, the Company cover the cost of your membership although this is a benefit in kind so taxable.  In addition, for a small cost, you can add your immediate family to the membership.

Life Assurance

4 x salary

Reward Gateway

Online benefits portal that offers discount/cash back on retailers/gym membership/mobile phones.

Learning & Development

Support development through various opportunities such as bespoke training, leadership development and further education opportunities.

Hybrid Working

Ability to work between office and home as defined by business need

Employee Assistance Programme

24/7 helpline

Dental Cover

Cashback on check-ups and treatments

Cover for oral cancer, injury and emergencies

Worldwide cover, whether they’re staying home or travelling