Our client a company which designs, develops and manufactures medical devices is recruiting for a NPI PM for Galway. This position requires an experienced and proven candidate with a background in managing the commercial transfer of innovative product-designs within a GMP-regulated medical devices industry. Candidates should have a minimum of 3 years of experience in managing the life-cycle transfer of products and packaging-systems from design-freeze through to qualified commercial manufacturing.
Due to exciting growth on a number of new product/ technology introductions in 2020, the successful candidate will deploy a matrix-management model in leading cross-functional NPI (new product introduction) teams which can encompass R&D, manufacturing-engineering, maintenance, EH&S, quality-engineering and supply-chain functions. This position will be challenging, involve exposure to implant product-designs and will require an ability to work autonomously whilst providing communication updates to all levels of the organisation including the site Leadership team. Customer-relationship management will be a key element of this role.
Duties and Responsibilities
- Project-management of cross-functional NPI teams in meeting internal and external (customer) quality, timeline and budget commitments.
- Seen by the site management team as a leader in transferring R&D-product and packaging designs into fully qualified commercial manufacturing.
- Assess and implement best practice tools in new product introduction from planning to risk management, communication to execution.
- Foster strong collaborative partnerships with R&D technical leads and cross-functional team members to develop accurate transfer roadmaps and timelines – with a particular focus on critical path analysis.
- Provide weekly project status update-presentations to the business
- Work closely with business development managers in establishing accurate timeline and cost estimates for entire projects – to allow cost proposals to be issued to external customers prior to transfer.
- Build on the existing design-transfer process on site to develop improved systems and processes for scaling communications, organising information, developing requirements documents, and running stage-gate checkpoint reviews.
- Drive strong adherence to all stage gate reviews for quality, regulatory and business purposes.
- Champion all life cycle development discussions with internal and external customers and lead the definition and final agreement of realistic, achievable and cost-effective product specifications.
- Planning, implementing and co-ordination of new product introductions to include: process scaling development, product and packaging specifications, IQ, OQ and PQ validations, identification of training needs, process & equipment layout, EH&S review, initial capacity planning and product-builder needs, production and QMS procedures, material specifications, material & packaging procurement, supplier approvals in accordance with company Procedures and Regulatory standards.
- Ensure the requirements of ISO13485 are considered during design, development and new product introduction and integrated into production processes.
- Use of statistical analysis as required as part of validation activity and defining subsequent inspection and controls in production.
- Develop and utilise DFMEA/PFMEA and other risk analysis techniques in order to minimise potential risk during development/implementation activity.
- Direct the compilation and execution of IQ/OQ/PQ validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures.
- Oversee Design History File maintenance (as required) on the customer’s behalf.
Education, Experience and Skills
- A Bachelor’s degree in manufacturing engineering, biomedical engineering, quality engineering, or related field and 3 years’ minimum experience is required in a project management role.
- A qualification in project management or related discipline is highly desirable.
- Successful candidate must have a strong track record of project completion within in a medical device environment. This role is considered a key role within the organisation and will involve the product transfer of Tier1-multinational-customer products – and as such, experience is essential.
- Ability to motivate and focus a large collaboration to reach challenging goals.
- Candidate must be highly motivated and passionate about meeting commercial business targets with excellent time-management, presentation, communication skills, technical writing skills and organisational skills.
- People management experience within a matrix model approach is highly desirable.
- Strong familiarity with FDA GMP/QSR; ISO 13485 and MDD medical standards is essential.
- Solid knowledge of PFMEA development, IQ/OQ/PQ validation is essential.
- Strong knowledge of statistical analysis is highly desirable.
- Working knowledge of packaging system design and qualification is highly desirable.
- Polymer/implant knowledge is desirable but not essential.
For further information on this PM role in Galway please contact Deirdre Finnerty on 086 3073779/ firstname.lastname@example.org
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