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).

Check out the spec below-

Qualifications

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

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

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

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• Experience with combination products or Class II/III medical devices.
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• Familiarity with lean manufacturing principles and continuous improvement methodologies.
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• Experience working with Notified Bodies or competent authorities.
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• Knowledge of sterile device manufacturing or cleanroom environments.
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If interested, please apply immediately, short-listing quickly!

Benefits:

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• Casual dress
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• Flexitime
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• Free parking
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• Private medical insurance
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• Sick pay
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Work Location: In person

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