Job Title: Process Engineer - 6 month contract
Make sure to apply with all the requested information, as laid out in the job overview below.
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).