a thriving area with an outstanding quality of life in the West of
Our Client requires a proven candidate with a background in commercial
transfer of innovative product-designs within a GMP/FDA/ISO regulated
medical devices industry. Candidates must have a minimum of 3 years of
experience in the transfer of products and packaging-systems from
design-freeze through qualification to commercial manufacturing. Due
to exciting growth on a number of new product/ technology
introduction, the successful candidate will liaise heavily with
cross-functional NPI (new product introduction) teams which can
D, manufacturing-engineering, maintenance, EH&
S, quality-engineering and supply-chain functions. He/She will work as
part of a team to develop and maintain high quality/performance/safety
standards on all assigned implant-products. Reporting to the NPI
Manager, the position will be challenging, involve exposure to the
latest Tier1-company implant product-designs and will require an
ability to work autonomously.
* Contribute to the New Product Introduction (NPI) teams with key
* 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
* design-for-manufacturing and product flow/layout development.
* Take ownership for the execution of process qualification related
builds an testing.
* Ownership of IQ, OQ, PQ protocol-generation, execution and
* 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
* Enjoy a multi-departmental approach to problem-solving where
everyone has a voice and is respected for their input in driving
* 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
* Deploy the principles of lean and six-sigma in identifying and
implementing the optimum areas for improvement in manufacturing
* There will be a strong linkage with the Quality Assurance department
in supporting the Regulatory and Compliance requirements of an ISO
**Apply on the website** organisation.
* Make appropriate decisions on a daily basis, using the NPI Manager
and Senior Engineering (NPI, Operations, Quality) representatives as
* Performs other related duties, as assigned.
_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**Apply on the website**; experience in a medical device
* 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
We need : English (Good)