Process Engineer

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).

Location: Oxford, UK, GB

Posted Date: 9/14/2025