NPI Program Manager
Negotiable
Medical Technology
Dublin
Permanent
Hybrid
(Hier) Bewerben
1. Job Description
New Product Introduction Program Manager
2. The Role
Responsible for Project Management of Projects within the Operations/NPI functions encompassing all project activities leading to clinical and commercial approval.
3. Reporting Lines
Reports to Head of Operations or designate.
4. Key Responsibilities and Duties
The individual will work under minimal supervision while performing the following duties:
Project Management
- Manage the development of new product introduction activities for CroíValve that meet patient, customer and business
- Serve as the Project Lead on one or more project, developing plans and goals for the project which meet the overall company goals.
- Develop project plans, timelines, budget and resource requirements and communicate these to
- Translate project plans and goals into work package ownership areas for team members and align with other management team members on individual goals and work package ownership for staff to ensure project goals are
- Strong project management skills to lead cross functional projects, ensuring on time and on budget delivery. Creative approaches to reducing project risks and shortening timelines while delivering business
- Provide support to team members in the execution of the work and delivery of project deliverables as the product advances through the design development cycle.
- Communicate with stakeholders across the company and externally to develop project/product inputs, set and manage expectations and provide updates on project progress, risks and
- Demonstrate collaborative leadership, being able to collaborate across multiple functions, beyond Operations/NPI.
- Develop a positive team culture to ensure a high-performance engineering team, where the sum of the team output is greater than their individual parts.
- Manage external vendors/partners to achieve project objectives and in the execution of project
Technical
- Review and manage updates to all manufacturing documentation: MPIs, DHRs, in-process / manufacturing specs, BOM, Flowchart, DMR throughout DV for FIH, in-line with Change
- Develop and maintain systems for inventory and stock management at both company, SCM and
- Identify and work with SCM and suppliers to source equipment appropriate to facilitate the robust manufacture of product, with verifiable processes both for manufacture and
- Ensure sufficient transfer of supply chain and manufacturing documentation to SCM as required as part of scale up
- Manage demand forecasting with internal functions and communicate these to suppliers across the supply chain to ensure continuity of supply, while maintaining a lean approach to inventory on
- Support and consult on all process validation activities as required.
- May provide Technical support to SCM for issue resolutions with component level
- Support audits of SCM and support supplier as required when auditing their supply chain.
- Ensure that manufacturing and process qualification activities and test plans align with regulatory
- Support regulatory submission-ready documentation for the FDA and other regulatory bodies as related to the product manufacturing
- Implementation of robust supplier performance and monitoring
- Ensure voice of suppliers/SCM is integrated into new design
- Support development and implementation of development and commercial supply agreements with suppliers.
People Leadership
- Coach and mentor more Senior and R&D engineers, without direct supervisory
While this is predominantly a project leadership role, this role may take supervisory/management responsibility of a small number of more junior engineers or technicians
- Ensure interactions with colleagues/stakeholders fully reflects the company values:
- One Team: working together to ensure the whole is greater than the sum of the parts
- Personal Ownership: deliver on commitments
- Open Communication: Honest open-minded communication
- Fun: celebrate the successes
- Continuous Learning: at an individual and company level
- Solution Orientated: Identify problems but focus your energy on solutions
- Quality Focused: patient safety comes first
5. Essential Requirements
- Technical: Strong technical capability with detailed understanding of technical principles, material and processes used in the manufacture of medical devices and Knowledge of key subject matters, including sterilisation processes and biocompatibility, including impacts of process and materials changes. Applies expertise and guidance in the selection of materials and processes from a DfX perspective. Knowledge of six-sigma/lean manufacturing and associated tools to support development of efficient and transferable manufacturing and assembly processes. Provides critical review of risk management and validation activities as these
relate to processes, including Measurement System Analysis and ensuring generation of robust validation plans. Supports technical transfer activities within supply chain and CMOs.
- Problem Solving: Facilitates a culture of collaborative, data-driven problem solving within the team to ensure timely resolution of technical issues with appropriate risk mitigation to ensure projects can progress as planned. Promotes best practice in relation to capture, analysis and communication of data to feed into technical decision-making across the company. Risk based problem solving to ensure highest risk items in the project are
- Project Management: Extensive project management skills. Is capable of developing project plans, timelines, budget and resource requirements and communicating these to stakeholders. Translates project plans and goals into work package ownership areas for team members and align with other management team members on individual goals and work package ownership for staff to ensure project goals are Uses best-in-class tools to effectively identify, track and communicate progress and project risks across all internal and external stakeholders and ensures such risks are effectively controlled with support of other management team members. Develops creative approaches to reducing project risks and shortening timelines while delivering business objectives. Is recognised as an effective leader and demonstrates associated behaviours to drive projects forward, including support and mentorship where required team members to maintain "on-track" progression. Experience / expertise in production planning and management. Ideally is a certified project manager, although this is not a requirement.
- Initiative: Manages the work of others and self under limited supervision and take initiative in communicating and alignment of project activities with Identify knowledge / experience gaps that exist within team and takes actions to address to ensure optimal performance. Is seen as a leader within the operations organisation.
- People Skills: Has emotional intelligence and ability to build strong relationships and to positively influence collaborators / stakeholders throughout the organisation, as well as external partners. Coach and mentor more Senior and R&D engineers, without direct supervisory authority. While this is predominantly a project leadership role, this role may take supervisory/management responsibility of a small number of more junior engineers or technicians.
- Communication: Communicates with stakeholders across the company and externally to develop project/product inputs, set and manage expectations and provide updates on project progress, risks and Proactive communication to ensure any potential significant issues are communicated upfront. Demonstrates collaborative leadership, being able to collaborate across multiple functions associated with the development of an operations infrastructure to deliver on company goals, including support submissions and filings where appropriate. Manages information to and from external vendors/partners as necessary to support project activities.
- IP: Actively supports team innovation through regular contribution of disclosures to company's
patent portfolio.
6. Education and Experience
- Degree or masters degree in mechanical engineering, or related
- Minimum of seven (7) years' experience in medical devices, with a minimum of 3 years in project management of technical projects across R&D and The projects should incorporate new product introduction, preferably in cardiovascular devices, in particular catheter delivery systems.
- Experience managing and collaborating with external
- Project management skills - capable of operating and liaison at all levels including managerial, project and Proven track-record in planning and resource management to meet defined
project goals. Experience with processes to identify and control risks within the project. Ideally PMP or Prince 2 certified or holds similar qualification.
- Deep and current understanding of FDA and ISO 13485 requirements, with the ability to interpret these requirements and implement them into new product introduction
- In depth knowledge of the EU Medical Device Regulation and MEDDEV guidance
- Experience in design, verification, and process validation
- Prior experience and knowledge in GMP, process validation, change control, CAPA and electronic document control systems.
- Broad knowledge of materials and manufacturing processes applicable to medical device industry is
- Demonstrated analytical problem-solving abilities to resolve complex technical issues. Ability to consume, analyse and structure information from numerous sources and stakeholders into clear formats to support communication, key decision-making and strategic
- Experience working with suppliers and vendors, including qualification and ongoing performance
- Experience of preparing technical documentation for manufacturing support and to support submissions
- Excellent communication, organisational and time management
- Good problem-solving
- Good leadership and project management skills with the ability and willingness to effectively build and manage a small team. Demonstrated experience in people mentoring and development without direct supervisory
- At ease in start-up environment and effectiveness to deliver in low-structured
- Demonstrated ability to communicate within a team/company structure and to achieve project and company
Availability to travel is required.
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