Project Mechanical engineer Medical Device
14 hours ago
Banbury
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 • 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! Benefits: • Casual dress, • Flexitime, • Free parking, • Private medical insurance, • Sick pay Work Location: In person JBRP1_UKTJ