Project Management Engineer in Witney

Medical Device Scale-Up Project—Contract Role

Company: Oxford Medical Products

Location: Witney, UK (on-site / hybrid)

Contract Type: Fixed-Term Contract — 6 Months

Extension: Subject to further funding and business requirements

Reports To: CEO / Head of Engineering

Start Date: As soon as possible

About Oxford Medical Products

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.

Role Overview

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 scale-up 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.

Key Responsibilities

• Project Planning & Delivery: 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.
• Engineering & Technical Coordination: 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.
• Regulatory & Quality Compliance: 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.
• Stakeholder Management: 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.

Essential Requirements

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

Experience

• 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.

Skills & Competencies

• 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 workstreams 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.

Desirable

• 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.