Project Mechanical engineer Medical Device

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 a permanent role, great benefits and a hybrid working arrangement(3 days in the office).

The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.

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. xwzovoh

If interested, please apply immediately, short-listing quickly! Benefits: Casual dress Flexitime Free parking Private medical insurance Sick pay Work Location: In person