R&D Engineer (Strong Technical Design Skills, Stress Analysis, FEA, DOE)

Job Summary

The R&D Engineer position requires experience in technical design analysis, including first principles design calculations, stress analysis, Finite Element Analysis (FEA), and Design of Experiments (DOE). The ideal candidate will have strong technical design skills, excellent written and oral communication, and leadership abilities.

Technical Product Design

• Drive design and development of product systems, subsystems, and components
• Integrate product systems and subsystems to meet business objectives
• Identify and leverage appropriate mix of first principles, analytical, computational, and experimental methods
• Ensure implementation and rigor of product development processes and design control procedures
• Evaluate and assess new technologies, intellectual property, products, processes, and industry trends
• Support current products in terms of quality, manufacturing, supply continuity, and cost improvement
• Support execution of technical and/or cross-functional project work
• Generate novel concepts for new products and enhancements to current product performance
• Translate customer needs into engineering requirements and 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 specifying measurement equipment, test setups, measurement systems analysis, and data analysis
• Develop realistic and actionable design plans

Project and Cross-Functional Leadership

• Demonstrate strong accountability for successful completion of designated tasks
• Develop deliverables schedules and demonstrate accountability for successful completion of tasks/projects and team deliverables
• Ensure efficient and effective transition from research to development to high volume manufacturing in locations worldwide
• Collaborate with laboratory technicians and support staff
• Ensure compliance with BD quality policies, procedures, and practices as well as with all local, state, federal, and BD safety regulations, policies, and procedures

Organizational Development

• Proactively develop, maintain, and share technical knowledge in specialized areas, staying updated on current trends and best practices
• Mentor and motivate team members and junior associates, ensuring effective cross-functional communication and engagement
• Develop and apply innovative approaches to ensure the effective capture, retention, and communication of technical and project knowledge generated (tacit and implicit)

Qualifications

• Bachelor's degree in Engineering (Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering, or a closely related engineering degree required)
• A Master’s degree in engineering is preferred
• Minimum of 3 years of engineering experience or equivalent is required with a strong preference for at least 2 years of product development and design experience in medical devices/products
• Medical device design and development experience related to high-volume manufacturing is strongly preferred
• Strong interpersonal and influencing skills
• Advanced technical judgment
• Strong communication skills
• Team-oriented
• Strong understanding of disciplined product development processes, regulatory, and quality requirements

Desired Qualifications

• Experience in statistical tools, computer analysis, and engineering fundamentals to support sound engineering judgment
• SolidWorks, Minitab, and FEA (Abaqus/Fluent) experience is preferred
• Experience in developing project plans
• Strong design control experience
• Experience writing invention disclosures, patent applications, patents, and publications
• 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 clinical studies, human physiology, and simulated product use studies
• Experience with contact and non-contact metrology
• Knowledge of high-volume manufacturing and assembly processes, particularly those of plastic injection molding, metal stamping, and automated assembly techniques, including solvent bonding, adhesive bonding, ultrasonic welding, and interference-fitting
• 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