Project Management Engineer

Project Management Engineer

Medical Device Scale-Up Project—Contract Role

Oxford Medical Products

Project Management Engineer — Medical Device Scale-Up

Witney, UK (on-site / hybrid)

Fixed-Term Contract — 6 Months

Subject to further funding and business requirements

CEO / Head of Engineering

As soon as possible

Oxford Medical Products is a medical device company committed to developing and delivering innovative healthcare solutions. We are currently undertaking a significant scale-up project to transition our products from development-stage volumes to full commercial manufacturing. This is an exciting opportunity to join a fast-paced, mission-driven team at a critical stage of growth.

We are seeking an experienced Project Management Engineer with a strong background in medical device manufacturing and regulatory environments to lead and coordinate our scale-up programme. The successful candidate will be responsible for driving project delivery in collaboration with our scaleup partner, ensuring that scale-up activities are executed on time, within scope and in compliance with applicable medical device regulations.

This is an initial 6-month contract with the possibility of extension subject to programme funding and business needs.

• Develop, own and maintain a comprehensive project plan for the scale-up programme, including milestones, resource requirements and critical path analysis.
• Lead cross-functional project meetings, track actions and report on progress against plan to senior stakeholders.
• Identify and proactively manage project risks, issues and dependencies, implementing mitigation strategies as required.
• Manage project budget and provide regular financial reporting to the CEO / CFO.

• Coordinate engineering activities required to scale manufacturing processes, including process validation (IQ/OQ/PQ), equipment qualification and tooling procurement.
• Work closely with R&D and manufacturing engineering teams to resolve technical issues arising during scale-up.
• Oversee the creation, review and approval of technical documentation including specifications, work instructions, protocols and reports.
• Support design transfer activities, ensuring robust handover from development to production.

• Ensure all scale-up activities are conducted in compliance with ISO 13485, MDR 2017/745, and other applicable standards and regulations.
• Work with the Quality team to ensure appropriate CAPA, change control and risk management processes are followed throughout the project.
• Support internal and external audits as required, including Notified Body interactions.
• Maintain the Design History File (DHF) and Technical File in line with regulatory requirements.

• Act as the primary point of contact for the scale-up programme, communicating progress and escalating issues appropriately.
• Prepare and present project status reports, risk registers and milestone updates to the leadership team and investors as required.
• Facilitate collaboration between internal teams and external partners, ensuring alignment on project objectives.

• Degree in Engineering, Manufacturing, Biomedical Engineering, or a related technical discipline.
• Project management qualification (e.g. PMP, PRINCE2, APM PMQ) is highly desirable.

• Minimum 5 years’ experience in a project management or engineering role within the medical device or regulated life sciences industry.
• Demonstrable experience of managing or contributing to scale-up, design transfer or NPI (New Product Introduction) projects in a medical device environment.
• Strong understanding of medical device regulations including ISO 13485, EU MDR, and FDA QSR/21 CFR Part 820.
• Proven experience with process validation methodologies (IQ/OQ/PQ) and associated documentation.
• Experience managing cross-functional teams and third-party suppliers or contract manufacturers.

• Excellent project planning and scheduling skills; proficient with project management tools (e.g. MS Project, Smartsheet, or equivalent).
• Strong analytical and problem-solving skills, with the ability to manage multiple work streams simultaneously.
• Highly organised with exceptional attention to detail and documentation standards.
• Confident communicator with the ability to engage effectively at all levels, from shop floor to board level.
• Self-motivated and able to operate with a high degree of autonomy in a fast-paced environment.

• Experience with combination products or Class II/III medical devices.
• Familiarity with lean manufacturing principles and continuous improvement methodologies.
• Experience working with Notified Bodies or competent authorities.
• Knowledge of sterile device manufacturing or cleanroom environments.