Lab Solutions are recruiting for a well funded medical device startup based in Oxfordshire, who are looking to revolutionise the obesity market!
They are currently looking to hire a Project manager engineer to oversea the building and running of their plant, this is initially a 6 month fixed term contract, with a strong possibility of going permanent.
Check out the spec below-
Qualifications
- 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.
If interested, please apply immediately, short-listing quickly!
Pay: £54,000.00-£55,000.00 per year
Benefits:
Work Location: In person
