Job ID: JOB-11763
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.
- Enjoy a multi-departmental approach to problem-solving where everyone has a voice and is respected for their input in driving root-cause-analysis reviews.
- Always strive to meet or exceed the expectations of our customers.
- 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.
- Performs other related duties, as assigned.
Key Requirements for the role
- 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’ 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 further information on this role please contact Tommy McKeown on 086 0100903 / email@example.com
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