Senior Process Development Engineer

To support and manage the efficient introduction of New Product and processes into manufacturing on time, within budget, to agreed yields and efficiencies and to the company’s quality standards. The Senior process development engineer plays a critical role within NPI & Manufacturing at ATL UK & Global. As part of the NPI team, the primary function is to take lead in assessment of new project requirements from a Process and manufacturing perspective. To conduct DFM/DFA and transfer that information, enabling the design, development and optimisation of processes for producing/manufacturing goods in line with customer expectations. 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. As a Senior Engineer there will be a required level leadership, mentorship, and reporting to management. Health & Safety : 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 – leading by example Process Design : Lead the Design, development, implementation and maintenance of assembly processes. Plan, coordinate and execute process design, Design For Manufacture / Assembly (DFM/A), validation and documentation on time and within budget; to include 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. Risk Assessment: Own the assessment of risk through creating the relevant PFMEA and input to any DFMEA activities to manage risk in the development process. New Process Projects : Be a key member and decision maker for new projects from concept to final release; providing input to Project Proposals on new product introduction (NPI) and process development timescales, resource levels, costs and risks to help drive accurate timelines, ensuring product/process is designed for manufacture. 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 GMP (Good Manufacturing Practice), process validations and other quality system documentation requirements to support new product introduction (NPI) and development. Documentation : Prepare manufacturing documentation, technical reports, presentations for above thus ensuring 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. This will include drawing review and document approvals for compliance and correct info. Continuous Improvement: In collaboration with other ATL-UK functions, assess and drive process methods to minimise process time and scrap. Maintain and improve product output, ensuring customer quality, 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 (QMS) 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. Knowledge of regulatory requirements and standards (e.g., FDA, MDR, EMA, ISO 13485.) People Development : Work with Management to ensure engineers are developed within the team. Focusing on core competencies and providing technical guidance, support and mentoring. Communication : Ability to communicate and present at all levels within the business, including external customers,. Ability to host engineer to engineer technical discussions (internal/external). Other: All other essential duties as directed. Education/Qualifications: Degree in Mechanical Engineering or related field; mechatronics or other electro-mechanical discipline Behaviours/Skills/Experience Good communication, verbal and written. Understanding of Medical Industry, design & development, 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. Knowledgeable in statistics and statistical analysis. 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, willing to take the lead and drive process tasks forward to meet project timelines. Ability to adapt to changing project requirements, flexibility to work in a fast-paced dynamic environment. Be a dynamic thinker, with ability to propose solutions and then manage/drive such solutions. Computer literate with Microsoft office suite. Acts with integrity; takes accountability for accuracy and quality of work. Understanding and delivering internal/external customer focus. What you should know about us: ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site (GML Medical Ltd – an ATL Technology owned Company) is based in St Mellons, Cardiff, UK. We believe there is a better way to bring medical devices to market. 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. ATL has operations in the UK, China, Costa Rica, Taiwan, UT-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 basic/standard/enhanced 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.