Sr R&D Engineer

Duties and responsibilities

• Technical Product Design
• Drive design and development of 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.
• Strong design control experience
• Developed understanding of DOE and statistical methods.
• 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 current products in terms of quality, manufacturing, supply continuity and cost improvement.
• Support execution of technical and/or cross-functional project work.
• 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.
• Demonstrate strong accountability for successful completion of designated tasks
• Develop deliverables schedules and demonstrate accountability for successful completion of tasks/projects and team deliverables
• Effectively collaborate with laboratory technicians and support staff

Qualifications

• BS or MS degree in Engineering (Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering or a closely related engineering degree required)
• Minimum of 3 years of engineering experience or equivalent is required with a strong preference for least 2 year product development and design experience in medical devices / products
• Medical device design and development experience related to high-volume manufacturing is strongly preferred.
• Strong communication skills.
• Team oriented.
• Demonstrated ability to utilize statistical tools, computer analysis and engineering fundamentals to support sound engineering judgment. Solidworks, Minitab, and FEA (Abaqus / Fluent) experience is preferred.
• Developed understanding of DOE and statistical methods.
• Understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions
• Experience with contact and non-contact metrology
• Experience with manufacturing process validation including strategy development, First Article Inspection, Factory Acceptance Testing, and IQ/OQ/PQ’s.
• Knowledge of disciplined product development processes, regulatory and quality requirements such as 21CFR820.30