Our client is at the forefront of medical device innovation, and they're looking for an NPI Engineer to join their dedicated team, reporting to the Lead NPI Engineer. This role is crucial for executing and delivering strategic projects that enhance manufacturing capacity and capability. You'll be involved in every stage of project delivery, from initial feasibility studies through to manufacturing start-up and seamless handover to the operations team.
Key Responsibilities
In this role, you will:
- Develop and refine manufacturing processes for new medical device projects.
- Manage multiple small to medium-scale projects, guiding them from concept through design for manufacture, commissioning, and qualification.
- Generate project proposals, plans, scopes of work, cost estimates, and quotations.
- Control the transfer of new product manufacturing processes to production.
- Liaise effectively with customer representatives, managing expectations regarding project progress, scope, and budget.
- Coordinate with various internal functional groups including EHS, QA, Manufacturing, Engineering, Supply Chain, Facilities/Maintenance, and Validation to ensure comprehensive project delivery.
- Track and report on project costs, schedules, targets, and achievements directly.
- Review and approve documentation, including specifications and drawings, and generate work instructions and action change notes.
- Manage internal and external teams to meet project schedules.
- Provide qualification and troubleshooting support for equipment and processes.
- Independently manage technical, engineering, and compliance matters, making decisions on engineering problems and methods.
What We're Looking For
We're seeking a candidate with:
- A minimum of 3-5 years of relevant experience in project management or research & development, ideally within a medical devices environment. We will also consider candidates from other similar regulated industries such as pharmaceuticals.
- A Bachelor's Degree (Honors) in Engineering (Level 8).
- Proficiency in MS Excel and MS Project.
- Commissioning and Validation experience, particularly with equipment and processes.
- Strong oral and written communication skills (must be able to read, write, and understand English).
- The ability to work on your own initiative and meet challenging schedules.
- A highly organized, adaptable, and flexible approach to NPI/Project Engineering.
- Initiative, creativity, resourcefulness, and the ability to work independently.
Ideally, you'll also have:
- Proficiency in a CAD package such as SolidWorks, or equivalent.
- Working experience in a manufacturing environment that is ISO 13485 certified.
- Proficiency in an MRP package such as SAP.
Work Environment
This role operates within a normal manufacturing environment. The successful candidate will be expected to adhere to all safety regulations, maintain a clean and orderly work area, and wear appropriate Personal Protective Equipment (PPE) as required. Flexibility to support company needs is essential.
If you're an experienced and proactive NPI Engineer looking to make a significant impact within a leading medical devices company, we encourage you to apply.
