My client, an expanding Medical Device Company just outside Galway City, is looking to hire an NPI Engineer to their growing team. The position requires a proven candidate with a background in the commercial transfer of innovative product designs within a GMP/FDA/ISO regulated medical devices industry.
Duties and Responsibilities
Contribute to the New Product Introduction (NPI) teams with key input into
Scaling, development, and validation of product, and packaging.
Equipment procurement and facility layout.
Initial capacity planning and identifying production operator needs.
Development of production and Quality procedures.
Material sourcing and procurement including supplier qualification input
Design-for-manufacturing and product flow/layout development.
Take ownership for the execution of process qualification related builds and testing.
Ownership of IQ, OQ, PQ protocol-generation, execution and reporting.
Initiate, maintain, update and review manufacturing, quality and engineering-related documentation as required – driving and reviewing Engineering Change Notice (ECN) proposals.
Assist with training of product builder staff on key operational tasks.
Perform facility-based EH&S, layout or energy-savings projects as required.
Coordinate and manage teams in meeting internal and external (customer) quality, timeline and budget commitment in transferring product and packaging designs into fully qualified commercial manufacturing processes.
Deploy the principles of lean and six-sigma in identifying and implementing the optimum areas for improvement in manufacturing operations.
There will be a strong linkage with the Quality Assurance department in supporting the Regulatory and Compliance requirements of an ISO13485 organisation.
Make appropriate decisions on a daily basis, using the NPI Manager and Senior Engineering (NPI, Operations, Quality) representatives as needed.
Reporting to the NPI Manager the successful candidate must have a track record of success in a manufacturing environment for a medical device company, a degree in Engineering or related field and 3 years of experience in a medical device engineering role.
Candidate must be highly motivated and passionate about developing new products with strong documentation, oral, and interpersonal communication skills required.
The individual must be proficient in Medical Device design principles and material selection with a knowledge of FMEA, TMV, MVP, IQ/OQ/PQ and software validation.
Possess strong analytical skills, with a hands-on approach. Project management experience is desirable.
For a confidential discussion and more information on the role please contact Rhys Joyce.