relocate to a thriving area with an outstanding quality of life in the
West of Ireland!
The position requires an experienced and proven candidate with a
background in managing the commercial transfer of innovative
product-designs within a GMP/FDA/ISO regulated medical devices
industry. Candidates must have a minimum of 5 years of experience in
the transfer of products and packaging-systems from design-freeze
through qualification to commercial manufacturing. The successful
candidate will be part of an NPI (new product introduction) team of
engineers and technicians to work cross functionally with Quality,
Operations, Design Services and Materials groups.
This position 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 as all product designs are
developed in conjunction with customers.
* 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
* Foster strong collaborative partnerships with technical leads and
cross-functional team members to develop accurate transfer roadmaps
* Provide regular project status update-presentations to customers and
* Drive strong adherence to all stage gate reviews for quality,
regulatory and business purposes.
* Lead all life cycle development discussions with internal and
external stakeholders and participate in the definition and final
agreement of realistic, achievable and cost-effective product
* Plan, implement and co-ordinate new product introductions through:
* 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.
* Support quality system requirements through design control methods,
design of experiments (DOE), computer aided design, and failure mode
and effects analysis (FMEA)
* Manage and support design verification and validation testing and
* Performs other related duties, as assigned.
_REQUIREMENTS_ for the role
Reporting to the NPI Manager Lead the successful candidate must have a
track record of success in a development and manufacturing environment
for a medical device company, a degree in Engineering or related field
and 5 years**Apply on the website**; 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 mechanical design principles and
material selection. This position has full responsibility and
authority to make necessary decisions and/or take action that is
required to carry out job duties
We need : English (Good)