Process Development Engineer (R&D)

Gyrus Medical Limited; Cardiff; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A rapidly expanding company in Cardiff is seeking a Process Development Engineer to contribute to New Product Introduction and manufacturing. The role involves process design, safety compliance, and continuous improvement to enhance product efficiency and quality, with a strong emphasis on the medical device sector. The ideal candidate will have a mechanical engineering background coupled with a proactive approach to innovation and teamwork.

Benefits

Hybrid Working

Bonus Scheme

Life Assurance 4 x salary

Private Medical Insurance

Employee Assistance Programme

Qualifications

• Experience in mechanical design for manufacture and new product introduction.
• Understanding of medical manufacturing processes and cleanroom protocols.
• Proficiency in data analysis and ability to read technical drawings.

Responsibilities

• Design, implement and maintain assembly processes.
• Evaluate new projects for process improvement.
• Ensure compliance with GMP and maintain documentation.

Skills

Analytical skills

Lean Manufacturing

Process control tools

Data analysis

Mechanics

Education

HNC or Degree in Mechanical Engineering

Mechatronics or related field

Tools

CAD (SolidWorks)

Job description

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Process Development Engineer (R&D), Cardiff

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Client:

Gyrus Medical Limited

Location:

Cardiff, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

3e913d846020

Job Views:

15

Posted:

18.06.2025

Expiry Date:

02.08.2025

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Job Description:

We are looking for a Process Development Engineer (R&D) to play a critical role within New Product Introduction (NPI) and 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, conducting 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.

The successful applicant will be responsible for:

• 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.
• Process Design: Design, develop, implement and maintain assembly processes. N ot 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 Innovati on: 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.
• 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.

We are looking for someone who has:

• A HNC or Degree in Mechanical engineering, Mechatronics or another related field.
• 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

We offer:

• Hybrid Working
• Bonus Scheme
• Life Assurance 4 x salary
• Private Medical Insurance
• Employee Assistance Programme

About ATL Technology

ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site is based in St Mellons, Cardiff.

We believe that there is a better way to bring medical devices to market and we use an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of one's life. It is our mission to be the leading provider of custom engineered solutions for top medical device manufacturers.

Aside from our site in the UK, we also have operations in China, Costa Rica, Taiwan and the USA; plus remote staff in strategic global locations... and we're growing!

Other information

You will be required to provide evidence of your eligibility to work and reside in the UK, in accordance with the requirements of Section 15 of the Immigration, Asylum and Nationality Act 2006. The role that you are applying for may require you to undertake a Disclosure & Barring Service (DBS) check.

At Gyrus Medical Ltd (An ATL Technology Company), we have a dedicated in-house recruitment team that cover all areas of the business. As a backup, we have a preferred supplier list (PSL) of vetted suppliers and as such, are unable to accept unsolicited CVs from recruitment agencies or search firms outside of our PSL (which is now closed to new suppliers). Please note that Gyrus or ATL will not be responsible for any fees, charges or terms associated with any such CVs. CVs will only be accepted from approved agencies where terms and conditions have been agreed and we have instructed them to work on specific positions. Agencies will be contacted by the recruitment team should we wish to engage their services. We do not take sales calls and politely request that you refrain from directly approaching the recruitment team or line managers and remove Gyrus Medical Ltd from your mailing list. Thank you for your understanding.

Gyrus Medical Ltd (an ATL Technology Company) is an equal opportunity employer.