Process Engineer
Posted 3 days ago by Skills Alliance
Negotiable
Undetermined
Undetermined
Oxford, England, United Kingdom
Summary: The Process Engineer role is a 6-month fixed-term contract based in Oxford, UK, focused on driving continuous improvement initiatives within a regulated medical device environment. The successful candidate will collaborate with cross-functional teams to ensure compliance, process robustness, and operational excellence. Key responsibilities include authoring technical documentation, supporting validation protocols, and contributing to health and safety initiatives. This position requires a hands-on approach and strong problem-solving skills in a fast-paced setting.
Key Responsibilities:
- Collaborate closely with existing Process Engineers to ensure aligned and efficient improvement efforts.
- Author and review Specifications, Standard Operating Procedures (SOPs), and Work Instructions.
- Partner with Regulatory Affairs and Quality teams to ensure compliance with medical device regulations.
- Prepare and review Change Controls, Risk Assessments, and other documentation supporting continuous improvement.
- Draft, execute, and document validation and qualification protocols for production equipment and processes.
- Support the specification, sourcing, and commissioning of new tooling and equipment.
- Work collaboratively across departments to drive process improvements and embed a culture of continuous improvement.
- Contribute to Health, Safety, Environmental, and Sustainability initiatives.
- Assist with general engineering and operational duties in a medical device facility.
Key Skills:
- Degree (or equivalent) in process, manufacturing, mechanical, biomedical, or general engineering.
- Proven experience writing high-quality technical documentation.
- Strong knowledge of formal engineering/process principles.
- Hands-on approach to process development, improvement, and validation.
- Excellent written and verbal communication skills.
- Self-motivated and able to manage multiple projects simultaneously.
- Strong interpersonal and collaborative skills.
- Experience or certification in Lean and/or Six Sigma (Green Belt preferred).
- Familiarity with process design principles and DFx methodologies.
- Knowledge of relevant medical device standards.
- Practical experience in manufacturing, testing, and servicing of safety-critical medical devices.
- Understanding of digital manufacturing, Industry 4.0, or MES systems.
- Experience working with external suppliers and contract manufacturers.
Salary (Rate): undetermined
City: Oxford
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Job Title: Process Engineer – 6 month contract
Job Type: Fixed Term Contract
Location: Oxford, UK (flexible onsite working)
Travel Requirement: Occasional international travel (up to 20%)
An innovative We are seeking a dynamic and hands-on Process Engineer (CI) to join a growing team. Under the direction of the CI & NPI (Technology Transfer) Manager, the successful candidate will support and drive continuous improvement initiatives across manufacturing and servicing operations, ensuring regulatory compliance, process robustness, and operational excellence. This role will work closely with cross-functional teams including Regulatory Affairs, Quality, and Operations, with a strong focus on problem-solving, process validation, and documentation in a highly regulated medical device environment.
Responsibilities
- Collaborate closely with the existing Process Engineer (CI) and the Process Engineer (NPI) to ensure aligned and efficient improvement efforts.
- Author and review Specifications, Standard Operating Procedures (SOPs), and Work Instructions in line with regulatory and quality requirements.
- Partner with the Regulatory Affairs and Quality teams to ensure compliance with medical device regulations and industry standards.
- Prepare and review Change Controls (CCs), Risk Assessments (RAs), Root Cause Analyses, SCARs, NCs, CAPAs, and other internal and external documentation that support continuous improvement programs.
- Draft, execute, and document validation and qualification protocols (IQ/OQ/PQ) for production equipment, testing apparatus, and manufacturing/servicing processes.
- Support the specification, sourcing, and commissioning of new tooling and equipment required for improvement activities.
- Work collaboratively across all departments and levels to drive process improvements and embed a culture of continuous improvement throughout the site.
- Actively contribute to Health, Safety, Environmental, and Sustainability initiatives and site targets.
- Assist with general engineering and operational duties associated with a fast-paced, expanding medical device facility.
Requirements:
- Degree (or equivalent qualification) in process, manufacturing, mechanical, biomedical, or general engineering—or equivalent experience in the medical device or a similarly regulated industry.
- Proven experience writing high-quality technical documentation including SOPs, Work Instructions, and Technical Reports.
- Strong knowledge of formal engineering/process principles, with the ability to evaluate and simplify complex technical issues.
- Hands-on approach to process development, improvement, and validation.
- Excellent written and verbal communication skills.
- Self-motivated, driven, and able to manage multiple projects simultaneously.
- Strong interpersonal and collaborative skills with the ability to work effectively across teams and departments.
Desirable Skills & Knowledge
- Experience or certification in Lean and/or Six Sigma (Green Belt preferred).
- Familiarity with process design principles and DFx methodologies.
- Knowledge of relevant medical device standards (e.g., ISO 14971, IEC 60601, ISO 13485).
- Practical experience in manufacturing, testing, and servicing of safety-critical medical devices.
- Understanding of digital manufacturing, Industry 4.0, or MES systems.
- Experience working with external suppliers and contract manufacturers.