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Senior Engineer, R&D
Ref No.: 17-05148
Location: Franklin Lakes, New Jersey
Position Type:Contract
Start Date / End Date: 09/11/2017 to 09/11/2018
Quals--
Position title R&D Senior Engineer for Product Engineering General Function We are seeking a Senior Engineer who will bring a solid foundation of technical experience and depth to bear on our most challenging product engineering projects and programs. The successful candidate will have a unique opportunity to be part of a dynamic product platform team in Client Medication & Procedural Solutions R&D. We are seeking a highly talented and passionate individual to help the team identify, develop and implement solutions in all phases of design control process that address current hypodermic product portfolios. The incumbent will join the Product Engineering team and will lead or contribute to the design, development and commercialization of medical device products. Specifically, the Senior Engineer is expected to: • Provide deep technical expertise and engineering excellence to medical device product engineering projects. • Evaluate and support key products in terms of regulatory compliance and remediation activities. • Ensure appropriate design control strategy and document control processes are followed in completion of designated project activities. • Participate in executing technical and/or cross-functional project work and effectively manage an extended R&D team. • Manage project resources and forecast adjustments as necessary. Responsibilities Specific responsibilities will include the following as well as other duties, as assigned: Product Engineering • Engineer robust and manufacturable 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, 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 Client quality policies, procedures and practices, as well as all local, state, federal and Client 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. Education and experience requirements This position requires the following qualifications: • MS degree in Mechanical Engineering or Biomedical Engineering or closely related disciplines (Ph.D. 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. Leadership and Project Management Experience • Experience leading global engineering teams of various experience level. • Experience with project initiation, planning, executing, tracking, closure and reporting. • Good understanding of medical device product development risk management methodologies. • Demonstrated ability to clearly and effectively communicate project plans, results and conclusions to management and cross-functional audience. • Proficiency with Microsoft Project or equivalent project planning software.