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January 23 2018

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Offer: NPI Project Manager:ORTHOXEL

Job description:

NPI Project Manager


   » Cork
   » Negotiable
   » Not disclosed
   » Updated 13/01/2018
   » HR this job is expired SaveSave Apply Now

Job detail

New Product Introduction (NPI) Project Manager, highlights include;Managing new product development from concept to regulatory approval, Participating in product roadmap development, Identifying and executing product enhancements for existing technologies

OrthoXel knows Orthopaedic Trauma. Our focus is on developing innovative surgeon-driven trauma devices that are intuitive to use and improve patient results while delivering value to the health care system.

OrthoXel's design philosophy centres on the belief that trauma devices should be multi-functional to give the surgeon the flexibility to choose the fixation that is right for each patient. Our evidence-located design process ensures that the best clinical research in fracture care is used to inspire devices that provide biomechanically optimal fixation. We bring this research-located approach to everything we do and we believe that better care starts with better implants designed with the surgeon in mind. More details available at

We are growing our team to include a New Product Introduction (NPI) Project Manager, the highlights of this function include;
   » Managing new product development from concept to regulatory approval
   » Participating in product roadmap development
   » Identifying and executing product enhancements for existing technologies
The candidate should have a hands-on approach to projects, good attitude and work ethic along with the capability to work in a flexible and small entrepreneurial environment. Flexible remuneration package available commensurate with practice.

   » Manage all activities in support of medical device product development, including; ideation, development, design freeze, testing, regulatory approvals and market readiness
   » Prioritise tasks and direction for the project team
   » Plan and lead design reviews and phase exits as needed
   » Participate in product roadmap development; develop detailed execution plans to realise company growth plans
   » Manage interactions with outsourced manufacturers and partners all over the development lifecycle
   » Ensure that all development activities are conducted pursuant to appropriate standards for completeness, accuracy and documentation conforms to company and regulatory expectations for safety, efficacy and compatibility with applicable industry standards
   » Demonstrate an knowledge of product functional and customer requirements. Collaborates with peers to develop appropriate testing to verify product meets requirements and sets appropriate specifications to ensure product relicapability and manufacturcapability
   » supervise testing of new products and investigate customer complaints on existing products
Desired expertise and practice
   » Degree qualified with a minimum of 7 years' practice in medical device product development/design
   » Thorough knowledge and knowledge of design control; must be familiar with phase gate design control process and requirements
   » Demonstrated capability to prosperously lead projects and to get results through others
   » knowledge of medical device manufacturing processes and controls
   » Proven track record in participating in major regulatory device submissions i.e. CE and 510(k)'s
   » capability to manage critical projects as part of an interdisciplinary team to meet project deadlines
   » Excellent problem solving, oral and written communication expertise
   » Must be self-motivated and detail oriented
   » capability to work as part of multi-disciplinary team of clinicians, engineers and senior management
Ref: 18-1
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   » Rubicon Centre, Bishopstown, Cork
   » 021 2429 600


Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Cork
Company Type Employer
Post Date: 01/13/2018 / Viewed 12 times
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