Educational Background:

A 4-year engineering degree in relevant field is required (i.e., Systems, Mechanical/Industrial & Production/Bio-medical/Chemical/Materials Engineering/ Instrumentation/)

Professional Experience:

• Minimum 12yearsofexperienceasaDesignEngineerinregulatedindustrylikemedicaldevice, aerospace, or department of defence. Medical device development experience preferred.
• Strong "Value Engineering" and "Should Costing" experience preferred.
• Minimum 4 years experience in Lead Engineering, Lean Product development methodologies is desired.
• Experience in modern high volume manufacturing (molding, assembly and distribution) is desired.

Job Responsibilities:

Technical Product Design:

• As a technical subject matter expert, drive design and development of medical product systems, subsystem and components by understanding design space with design options and tradeoffs, managing critical parameters, using design for manufacture principles as well as geometric dimensioning and tolerancing tools.
• Responsible for cost saving change implementation at manufacturing locations.
• Integrate product systems and subsystems to meet business objectives by addressing customer needs and product requirements under defined cost targets.
• Identify the best tools and approaches to effectively solve engineering problems to develop/optimize designs by leveraging appropriate mix of first principles / analytical, computational and experimental methods.
• Ensure implementation and rigor of product development processes and design control procedures.
• Support evaluation and assessment of new technologies, intellectual property, products, processes and industry trends that can or have the potential to impact our business strategies.
• Support current products in terms of quality, manufacturing, supply continuity and cost improvement.
• Lead execution of technical and/or cross-functional project work.
• Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance.
• Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies.
• Translate customer needs into engineering requirements into specific product, packaging and process specifications.
• Analyze design solutions using engineering first principles and advanced engineering methods such as FEA
• Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
• Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis
• Develop realistic and actionable design plans.
• Mentor junior engineers and technicians in the execution of R&D project deliverables. Follow the Design Control process for medical devices and ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.
• Lead and contribute towards Product Innovations & Intellectual Property generation

Project and Cross-Functional Leadership:

• Demonstrate strong accountability for successful completion of designated tasks
• Develop project schedules and demonstrate strong accountability for successful completion of projects/programs and team deliverables
• Ensure efficient and effective transition from research to development to high volume manufacturing in locations throughout the world
• Provide project leadership to cross-functional teams comprising QA, Medical Affairs, Regulatory Affairs, Marketing, and Manufacturing team members
• Effectively lead and direct the work of other engineers and laboratory technicians
• Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures