Manufacturing, Production Engineer
il y a 2 jours
Sheffield
Salary: £45,000 - £50,000 Location: Harrietsham, Kent Application and Interviews The job advert closes by the 19th July 2026, with 1st stage telephone interviews and second stage face-to-face interviews scheduled to be held the last 2 weeks of July 2026. The Story: Established in 1976, Bedfont is an award-winning medical technology company based in Harrietsham, Kent. Its breath analysis medical devices are exported globally thanks to its network of carefully selected distributors. The Challenge: Healthcare is evolving, and the market for breath analysis monitors is expanding. Bedfont are looking for hard-working, like-minded, and passionate individuals to join the Bedfont Family to help achieve its goal of innovating healthcare worldwide. The Benefits: • 25 days paid holiday plus bank holidays, • Social events, • Private medical insurance, • Subsidised health checks, • Well-being warriors, • Well-being garden and room, • Annual optical allowance, • Cycle to work scheme, • Pension scheme, • Bonus scheme, • Hybrid working, • Employee Assistance Programme (EAP), • Rewards and discounts platform, • Referral bonus, • Charity days, • Home office setup allowance, • Employee awards, • Free on-site parking, • Training & development opportunities, • Free uniform, • Subsidised kids club, • Subsidised Celler8 Devices, • Time in service annual leave bonus, • Enhanced Maternity and Paternity PayYour Mission: The Production Engineer is responsible for ensuring the successful transfer of products, technical documentation, and quality requirements from R&D into Operations, supporting the efficient and compliant manufacture of Bedfont's medical devices. The role leads the implementation of manufacturing changes, controls Device Master Record (DMR) updates, supports pilot builds and process validation activities, and drives continuous improvement through Lean manufacturing principles. Working closely with Purchasing, Supply Chain, Warehouse, Production, and Quality teams, the Production Engineer ensures that manufacturing processes, technical information, and quality standards are effectively established and maintained to support operational excellence. Roles and Responsibilities: • Own and maintain the Device Master Record, ensuring all documentation is accurate, up to date, and subject to robust version control procedures., • Control the release, distribution, withdrawal, and archiving of technical documentation, ensuring only approved versions are available for operational use., • Ensure Purchasing and Supply Chain activities are aligned with the current approved DMR revision and associated technical specifications., • Lead New Product Introduction activities, including design transfer, pilot builds, manufacturing planning, and production readiness assessments., • Manage DMR control processes, ensuring technical files, revision histories, and document workflows are maintained in accordance with company and regulatory requirements., • Establish and maintain efficient manufacturing environments through the implementation of Lean manufacturing principles, 5S methodologies, cellular workflows, tooling, fixtures, and ESD controls., • Develop, maintain, and control manufacturing documentation, including work instructions, control plans, process documentation, and operator training records., • Coordinate and support process validation activities, including Installation Qualification, Operational Qualification, and Performance Qualification, ensuring compliance with quality and regulatory requirements., • Work closely with Supply Chain Manager and Warehouse team to ensure Approved Vendor Lists, purchase order specifications, and incoming inspection requirements are effectively implemented and maintained., • Drive continuous improvement initiatives across Operations through the application of Lean Manufacturing, Six Sigma methodologies, Poka-Yoke techniques, and structured problem-solving approaches., • Review and approve the release of technical documentation to Operations and Supply Chain, ensuring all documentation is complete, accurate, and authorised prior to implementation., • Exercise authority to halt the implementation of manufacturing changes, production activities, or documentation releases where non-compliance, quality concerns, or uncontrolled changes are identified., • Act as a key liaison between Research & Development, Quality, Purchasing, Supply Chain, Warehouse, and Production teams to ensure the effective transfer of products, processes, and technical information into manufacturing., • Provide technical guidance and support to operational teams to ensure manufacturing processes are implemented consistently, efficiently, and in accordance with quality standards., • Support business objectives by identifying opportunities to improve manufacturing efficiency, product quality, compliance, and operational performance.Qualifications: There are no specific formal qualifications required for this role; however, candidates should be able to demonstrate the following qualifications, knowledge and experience: • Degree/HND in Mechanical Engineering, Electronics Engineering, Mechatronics Engineering, Manufacturing Engineering, or equivalent industry experience., • Minimum of 5 years' experience within a manufacturing or production engineering environment, preferably involving electro-mechanical products., • Demonstrable experience implementing and supporting Lean Manufacturing principles, 5S, cellular manufacturing and Poka-Yoke methodologies., • Experience conducting process validation activities, including IQ, OQ and PQ protocols., • Experience completing and maintaining PFMEA documentation and risk assessments., • Understanding of control plans, Statistical Process Control (SPC) and process capability analysis., • Knowledge of Design History File (DHF), Device Master Record (DMR) and document control requirements aligned to ISO 13485 and FDA 21 CFR Part 820/QMSR., • Experience working within regulated manufacturing environments and supporting quality management systems.Valuable Expertise: Essential Skills • Ability to interpret and work from mechanical drawings, pneumatic schematics and PCB assembly drawings., • Strong problem-solving and root cause analysis skills., • Ability to develop, improve and document manufacturing processes., • Understanding of engineering change control processes and manufacturing documentation requirements., • Strong organisational skills with the ability to manage multiple projects and priorities simultaneously., • Effective communication skills with the ability to work collaboratively across Engineering, Quality, Production and Supply Chain teams., • Understanding of firmware and software release control processes., • Awareness of ESD protection requirements and EMC handling practices., • Ability to support validation, troubleshooting and continuous improvement activities within a production environment. Preferred Skills • Experience working with handheld electro-mechanical or medical devices, including PCBs, moulded components and pneumatic systems., • Strong background in New Product Introduction (NPI) and design transfer into production., • Hands-on experience with DMR management and engineering change control processes., • Familiarity with final assembly, PCB assemblies, functional testing and system-level validation., • Experience working with suppliers and subcontract manufacturers, including PCB suppliers, moulding suppliers and standard component providers., • Practical knowledge of Lean Manufacturing implementation, assembly optimisation and waste reduction techniques., • Experience operating within an ISO 13485-certified medical device environment., • Knowledge of FDA QMSR requirements and medical device regulatory expectations. In addition, employees may be required to undertake other duties as may reasonably be required of them. In these circumstances, training will be given where it is considered. Bedfont Scientific Ltd. does not and will not discriminate in the recruitment or management of staff on the basis of race, colour, religion, gender, age, disability, marital status, sexual orientation, or more. We are an equal opportunity employer, and Bedfont regards every employee as a member of the Bedfont family and is committed to providing a fair, safe, diverse and welcoming atmosphere. Our application process has been designed so that everyone is able to demonstrate their skills and how they meet the criteria required for the job advertised. All successful candidates will be subject to a digital ID and DBS check. JBRP1_UKTJ
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