Process Engineer
16 hours ago
Oxford
Job Title: Process Engineer - 6 month contract Job Type: Fixed Term Contract - Full Time Location: Oxford, UK A world-leading medical technology company developing cutting-edge solutions is seeking a skilled Process Engineer to drive the successful transfer and optimization of new medical device products and manufacturing processes from R&D into large-scale production as part of its global growth. This role offers the opportunity to work in a dynamic, innovative medical device organization dedicated to improving patient outcomes. As a Process Engineer, you will play a key role in ensuring that new products are introduced to market efficiently, with a strong focus on compliance, quality, safety, and scalability. You will be responsible for developing, validating, and continuously improving manufacturing processes, while collaborating closely with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing to enable smooth scale-up and commercialization. Responsibilities: • Working closely with the other departmental Process Engineer (CI) and the Process Engineer (NPI)., • Creating and reviewing Specifications, Standard Operating Procedures and Work Instructions., • Working closely with the Regulatory Affairs and Quality departments to ensure compliance with relevant medical device regulations., • Creating and reviewing Change Controls (CCs), Risk Assessments (RAs), Root Cause Analysis investigations, Supplier Corrective Action Reports (SCARs), Nonconformance Reports (NCs), Corrective and Preventive Actions (CAPAs) and other internal & external documentation needed to support the CI programs., • Drafting and executing validation and qualification protocols for production and test equipment, along with relevant processes used in manufacturing (internal & external) and servicing., • Assisting with specifying, sourcing and commissioning of tooling/equipment required for CI activities., • Working collaboratively with colleagues on all levels in all departments to improve current processes and develop a culture of continuous improvement., • Actively contributing towards the sites Health, Safety, Environmental and Sustainability requirements and targets., • Assisting with general duties associated with a busy, expanding site. Requirements: • A degree/equivalent qualification (in process, manufacturing, mechanical, biomedical or general engineering, or other relevant discipline) or experience in the medical device industry (or a comparably highly regulated industry) (essential)., • Good working knowledge or qualifications in improvement methodologies such as Lean or Six Sigma (Green Belt desirable), • Good working knowledge or qualifications in process Design & Review (DFx), • Good working knowledge of the Safety, Quality and Regulatory Standards applicable (ISO 14971, IEC 60601, ISO 13485 etc) to manufacture of medical devices (desirable), • Good practical skills and experience in the manufacture, release testing and servicing of safety-critical devices (desirable), • A hands-on approach to developing, evaluating, and improving processes, • The ability to evaluate, explain and simplify complex technical issues., • Proven strong knowledge and understanding of formal engineering/process principles and techniques., • Previous experience writing clear and concise Work Instructions, Standard Operation Procedures and other relevant Quality Documentation; acting as a Quality Technical writer., • The ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English., • Good understanding of manufacturing equipment and related systems., • Experience with validation protocols (IQ/OQ/PQ), FMEA, and control plans., • Familiarity with digital manufacturing, Industry 4.0, or MES systems., • Strong and concise communication skills, both verbal and written., • The ability to work effectively with outside suppliers and manufacturers., • Self-motivated and driven to succeed., • Very strong collaborative skills., • The ability to work across a wide range of projects simultaneously., • Willing and able to travel outside UK on occasion (less than 20% of time).