Job Type: Full Time
Reports To: Head of Programme Management and Operational Excellence
Main Purpose of the job:
Executes and delivers key strategic projects, which increase the capability and capacity of Schivo Medicals Manufacturing and Assembly Operations.
Applies engineering skills applicable to medical devices manufacturing, for all aspects of project delivery from feasibility, through manufacturing start up and hand over to the operations team.
Aligns the requirements of other functional groups such as EHS, QA, Manufacturing, Engineering, Supply Chain, Facilities/Maintenance, and Validation for an overall project delivery.
Directly responsible for tracking project cost, schedule, targets and achievements.
Skills & Competencies:
• Proficient in Oral & Written communication skills
• Must be able to read, write and understand English
• Proficient in MS Excel & MS Project
• Commissioning & Validation Experience – Equipment & Process experience preferred
• Proficiency in a CAD package such as Solid Works, or equivalent, preferred
• Proficiency in a Statistical Analysis package such as Minitab, or equivalent, preferred
• Proficiency in an MRP package such as SAP, preferred
• Ability to work on own initiative and to challenging schedules
• Organized and adaptable with a flexible approach to Project Engineering
Experience and Knowledge:
• Minimum 3 years of relevant experience within a medical devices environment, will also consider other similar regulated industries such as pharmaceuticals.
• Minimum of Bachelors’ degree (Honors) in Engineering (Level 8). 2:1 Minimum
Key Duties/ responsibilities:
• Manage multiple small to medium medical device projects from concept through design for manufacture, commissioning and qualification.
• Assist Supply chain in identification of suppliers and sub-contractors.
• Apply sound engineering and project management principles, in the delivery of the project.
• Interface with client representatives, and other functional groups such as EHS, QA, Manufacturing, Engineering, Supply Chain, Facilities/Maintenance, and Validation etc., to manage and coordinate the development of project deliverables.
• Generate project plans, scopes of work, cost estimates and quotations.
• Generate work instructions and action change notes.
• Manage internal / external teams to meet project schedules.
• Review and approve documentation including specifications and drawings.
• Manage manufacturing, assembly, tooling/fixture design and commissioning & validation activities.
• Review and/or approve commissioning and qualification protocols.
• Provide qualification and troubleshooting support for equipment and processes.
• Independently manage technical, engineering and compliance matters relating to the project delivery, by making decisions on engineering problems and methods.
• Employee is expected to follow all safety regulations, keep work area in a clean and orderly condition, and wear appropriate Personal Protective Equipment (PPE) as required for the assigned work area(s). Performs safety related duties as assigned.
• Working conditions are normal for a manufacturing environment. Machinery operation requires the use of safety equipment to include not limited to safety glasses.
• Must be flexible to support company as needed.