*Hi,*


*Hope You are Doing Good.*



*Please Let Me know Your Feedback..*

*Position:* *Process Development Engineer*

*Location : Cincinnati, OH,USA.*



The candidate should be from Manufacturing & Design who can act as liaison
between R&D team & vendors.

Or in another words you can also look for Manufacturing Process Engineer.
Medical experience is not a priority here but the candidate should have
some vendor handling responsibilities as well.



*Process Development Engineer*



The process development Engineer will design and develop medical device
mechanical/ electromechanical systems. Assignments are broad in nature,
usually requiring initiative, originality, ingenuity and excellent
problem-solving skills. Knowledge in the selection of various materials and
adhesives for medical devices along with experience designing for high
volume manufacturing are key areas. Experience in designing for automated
assembly is a plus.



*Education:* Degree in Mechanical Engineering or related.

*Experience:* More than 8 years in Medical Devices Manufacturing Process



*Skill set:*

·         Design transfer to manufacturing.

·         Leading the development of manufacturing processes, verification
and validation and design transfer to manufacturing.

·         Provide inputs to product design team on DFA, DFM...etc.

·         Provide inputs to product and design verification and validation
plans.

·         Participate in DOE’s and maintain records.

·         Liaison with vendors and suppliers of materials, tools and
components.

·         Well versed with statistical analytical techniques and s/w tools
like MATLAB, MINITAB.

·         Participate in developing prototypes, process and equipment to
support manufacturing.

·         Process verification and validation including IQ, OQ and PQ

·         Compile documents to meet al Quality, regulatory, PLCP based SOP
requirements.

·         Past experience as a design engineer will be an added advantage.

·         Project planning – resourcing, timelines, quality and budgets.

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