Sr. New Product Introduction Engineer

Position Description & Requirements :Duties & Responsibilities:
Leads global operations functions as a core team member for new product introduction. May focus on Mechanical, Electromechanical, Software Driven, or disposable products.

Works with plant level leadership to integrate New Products and Operational Excellence Tools, generate resource plans, and timelines for new and derivative products.

Works with local and international manufacturing sites to generate capacity/capability models and make vs. buy assessments that will be used as an input to site planning.

Leads manufacturing system design activities focused on work content, manufacturing capacity, scalability, throughput, and manufacturing line layout.

Provides expertise in project planning and timeline development & management

Provides input and support in refining the Operational deliverables for new product introduction using a phase gate approach.

Leads design for manufacturability in order to input design requirements early into the product development process.

Defines equipment automation and test strategies associated with electromechanical systems

Understands work environment issues (i.e. OSHA regulations, etc.).

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Qualifications: Education:BS in ME, IE, EE, CS, or related field. Experience:
5-8 years of experience – Medical device or FDA regulated industry experience preferred

Experience in process validation, production documentation, and manufacturing line support

Demonstrated experience with lean principles a must Skills:
Strong understanding of Design Control elements and pervious experience with design transfer activities

Demonstrated experience managing teams (indirect or direct) and has strong project management/time management skills

Broad processing and operational management knowledge

Strong analytical, problem solving and project management skills

Demonstrated leadership capability in team settings

Ability to work in a geographically diverse business environment

Ability to leverage and/or engage others to accomplish projects

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Multitasks, prioritizes and respects deadlines

Strong organizational and follow-up skills, as well as attention to detail Additional Information:

Ability to travel up to 20% of the time for short periods of time both domestically and internationally

Ability to work flexible hours based on international communication requirements

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Company Overview : At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets. Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for supporting managing chronic illness. Smiths Medical is an EEO/AA Employer/Vet/Disabled If you require assistance with our online job submission process, please contact our Talent Acquisition team at 855-754-5032 to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS). .