Product Design Engineer - Med Devices, Disposables
UpStream Global Services - Franklin Lakes, NJ

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We have an immediate opportunity a Product Design Engineer in the Franklin Lakes, NJ area. This position is within the R&D organization and will contribute to design and development activities focused on identifying, developing and implementing solutions to support the current product portfolio. More specifically, the job responsibilities will include:

: Support current products in terms of quality, manufacturing, supply continuity and cost improvement Support design and development activities for products within the current portfolio offerings

: Ensure appropriate processes are followed for effective and timely engagement of related parties in completion of designated project activities

: Use creative and critical thinking to devise new approaches to solve technical problems and leverage understanding of engineering principles, advanced engineering methods, data and judgment to support approach

: Participate as a member of a cross-functional team to deliver to business-critical R&D project commitments. Independently plan, implement, monitor and deliver designated tasks and deliverables to achieve project driven objectives

: Ensure compliance with quality policies, procedures and practices as well as with all local, state, federal and company safety regulations, policies and procedures

: Contribute to a culture of innovation by proactively generating novel concepts to improve current product performance or enhance current products' ability to address customer needs

: Minimum BS, preferably MS degree in Mechanical Engineering, BME or other technical discipline with at least 3-5 years' experience in Medical Devices as a product design / development engineer

: Experience with implementing product changes through a structured, phase-gated Design Control process

: Experience with designing and developing disposable medical device products for high-volume manufacturing methods such as injection molding, automated assembly and packaging processes

: Demonstrated experience with all phases of the Design Control process in the context of FDA regulation and understanding of disciplined product development processes, regulatory and quality requirements for medical products

: Demonstrated understanding of product design development considerations for tightly controlled, high-volume manufacturing processes

: Good understanding of medical device product development risk management methodologies

: Solid understanding of design verification and validation requirements management process, with demonstrated experience in strategy and implementation of these activities

: A clear understanding of manufacturing process validation including FAI/FAT, development and IQ/OQ/PQ

: Advanced engineering and design skills (CAD/CAE) (Pro/E, Solidworks or equivalent)

An excellent interpersonal, written and verbal communication, and influencing skills, strong technical judgment and problem solving skills and experience in project planning is essential.

For immediate consideration please contact:

UpStream Global Services