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Senior Engineer, R&D - Franklin Lakes, NJ

Lancesoft Inc
Franklin Lakes, New Jersey, 07417, United States
March 21, 2017


MS degree in Mechanical Engineering or Biomedical Engineering or closely related disciplines (PhD. preferred). • Minimum of 5 years post graduate experience as a product design / development engineer in the medical device or pharmaceutical industries (experience with FDA class II or III medical devices preferred). • Strong analytical and problem-solving skills with demonstrated capability of breaking down complex technical challenges to identify root cause and find innovative and robust solutions. • Demonstrated ability to formulate rationales with engineering justifications as appropriate. • Demonstrated experience with all phases of the Design Control process and understanding of disciplined product development process. • Expert understanding of management of design inputs and product requirements, including regulatory and quality requirements for medical products. • Preferred experience with plastic manufacturing/injection molding for medical devices in an FDA-regulated design control environment. • Experience in robust design verification strategy and execution, including worst-case conditions and utilization of FEA. • Proficiency with Minitab statistical software. • Proficiency and hands-on experience with advanced applications of DOEs. • Understanding of Critical Parameters Management. • Basic experience in SolidWorks or other equivalent 3-D CAD software. • Experience with Geometric Dimensions and Tolerances (GD&T). • Strong understanding of intellectual property considerations. • Excellent technical writing skills. Disciplined and well organized in documentation. Demonstrated ability to clearly and effectively communicate concepts. Responsibilities: Product Engineering • Engineer robust and manufactural products or improvements to existing products through strong understanding and application of engineering fundamentals. • Analyze design solutions using engineering first principles and advanced engineering methods, such as FEA. • Solve technical challenges drawing on a combination of experience, sound judgment, and problem solving skills and advanced engineering methods. • Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis and data analysis. • Develop realistic and actionable design plans. • Develop design verification traceability matrices and associated requirements analysis. • Interface with key stakeholders from manufacturing plants. • Ensure compliance with quality policies, procedures and practices, as well as all local, state, federal and safety regulations, policies and procedures. • Write detailed technical reports based on design verification analysis/testing for design changes and product design activities. • Leadership and Project management • actively coach colleagues and teams, and encourage and facilitate continuous learning. • Demonstrate strong accountability for successful completion of designated tasks. • Effectively lead and direct the work of other engineers and laboratory technicians. • Proactively develop, maintain and share technical knowledge in specialized areas, remaining up-to-date on current trends and best practices. Skill Requirements Description Exp (Mos.) Comments Mechanical Engineer 48 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