Smith & Nephew
Staff R&D Engineer (Austin, TX)
Smith & Nephew, Austin, Texas, us, 78716
Staff R&D Engineer (Austin, TX)
Life Unlimited.
At Smith+Nephew we design and manufacture technology that takes the limits off living.This is a great opportunity to apply your engineering expertise driving the development of market-leading solutions for health care providers and their patients. This role will expand the Smith+Nephew Ear, Nose, and Throat (ENT) product portfolio, which includes single-use disposable devices, electrosurgical devices, and systems. Successful candidates will provide technical leadership of research and development activities from ideation through commercialization, including device design, prototyping, user evaluation, test method development, risk evaluation, verification, and validation, while ensuring compliance with applicable standards and documentation required for the product.What will you be doing?Design, prototype, and develop innovative concepts for new and/or improved products for minimally invasive and open surgical procedures that meet customer needs, manufacturability (DFM) targets, quality requirements, and reliability goals.Generate design control requirements including design inputs, 3D models and assemblies, model-driven drawings, and detailed specifications in accordance with medical device regulatory guidelines (e.g. US FDA, European MDR, ISO, etc.).Partner with surgeons and other healthcare professionals to identify unmet user needs, improve product designs, support usability characterization, and then translate customer inputs and feedback into user needs and design requirements.Generate intellectual property in support of novel ideas and concepts.Collaborate closely and effectively with cross-functional partners, including Marketing, Quality Assurance, Regulatory Affairs, Procurement, and Manufacturing to drive projects to completion within schedule.Identify, collaborate with, and manage internal partners and external vendors on material selection, tool design, manufacturing technologies and specifications for components, subassemblies, and finished assemblies as required.Manage the working partnerships with multiple external resources contracted for the concept/product development, prototype/pilot fabrication, and testing of devices.Evaluate physical systems and designs using analytical and experimental methods including, but not limited to, Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), mechanical force application, electrical data acquisition, audio and video capture.Define test methods, develop test fixtures, generate design verification and design validation test plans, execute testing of complex mechanical and/or electro-mechanical systems, and author test protocols and reports.Conduct root cause analysis of technical problems encountered throughout a project (e.g. observation, manipulation, and testing of failed systems), and identify and assess potential solutions.Support pre-clinical and/or clinical testing of devices and systems.Conduct detailed design reviews at various design stages.What will you need to be successful?Education:
B.S. or M.S. degree in Mechanical or Biomedical Engineering, or other closely related field.Experience:
B.S. degree + 6 years hands-on experience in medical, medical diagnostic, aerospace, automotive, or similarly regulated field; M.S. degree + 3 years hands-on experience in medical, medical diagnostic, aerospace, automotive, or similarly regulated field; Minimum 2 years in the medical device industry with experience at all stages of a product lifecycle from ideation to commercialization. The ideal candidate is passionate, driven and motivated to succeed while maintaining a positive team environment.Leadership if any:
Technical oversight and leadership of projects and sub-systems; No direct managerial responsibilities but may be asked to mentor and train junior staff.Travel Requirements:
10-25%, depending on program or phase of program; may require occasional international travel.You. UnlimitedWe believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.Inclusion, Diversity and Equity:
We are committed to welcoming, celebrating and thriving on diversity.Other reasons why you will love it here!Your Future:
401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement.Work/Life Balance:
PTO, Paid Holidays, Flex Holidays, Paid Community Service Day.Your Wellbeing:
Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program.Flexibility:
Hybrid Work Model (For most professional roles).Training:
Hands-On, Team-Customized, Mentorship.Extra Perks:
Discounts on fitness clubs, travel and more.Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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Life Unlimited.
At Smith+Nephew we design and manufacture technology that takes the limits off living.This is a great opportunity to apply your engineering expertise driving the development of market-leading solutions for health care providers and their patients. This role will expand the Smith+Nephew Ear, Nose, and Throat (ENT) product portfolio, which includes single-use disposable devices, electrosurgical devices, and systems. Successful candidates will provide technical leadership of research and development activities from ideation through commercialization, including device design, prototyping, user evaluation, test method development, risk evaluation, verification, and validation, while ensuring compliance with applicable standards and documentation required for the product.What will you be doing?Design, prototype, and develop innovative concepts for new and/or improved products for minimally invasive and open surgical procedures that meet customer needs, manufacturability (DFM) targets, quality requirements, and reliability goals.Generate design control requirements including design inputs, 3D models and assemblies, model-driven drawings, and detailed specifications in accordance with medical device regulatory guidelines (e.g. US FDA, European MDR, ISO, etc.).Partner with surgeons and other healthcare professionals to identify unmet user needs, improve product designs, support usability characterization, and then translate customer inputs and feedback into user needs and design requirements.Generate intellectual property in support of novel ideas and concepts.Collaborate closely and effectively with cross-functional partners, including Marketing, Quality Assurance, Regulatory Affairs, Procurement, and Manufacturing to drive projects to completion within schedule.Identify, collaborate with, and manage internal partners and external vendors on material selection, tool design, manufacturing technologies and specifications for components, subassemblies, and finished assemblies as required.Manage the working partnerships with multiple external resources contracted for the concept/product development, prototype/pilot fabrication, and testing of devices.Evaluate physical systems and designs using analytical and experimental methods including, but not limited to, Finite Element Analysis (FEA), Computational Fluid Dynamics (CFD), mechanical force application, electrical data acquisition, audio and video capture.Define test methods, develop test fixtures, generate design verification and design validation test plans, execute testing of complex mechanical and/or electro-mechanical systems, and author test protocols and reports.Conduct root cause analysis of technical problems encountered throughout a project (e.g. observation, manipulation, and testing of failed systems), and identify and assess potential solutions.Support pre-clinical and/or clinical testing of devices and systems.Conduct detailed design reviews at various design stages.What will you need to be successful?Education:
B.S. or M.S. degree in Mechanical or Biomedical Engineering, or other closely related field.Experience:
B.S. degree + 6 years hands-on experience in medical, medical diagnostic, aerospace, automotive, or similarly regulated field; M.S. degree + 3 years hands-on experience in medical, medical diagnostic, aerospace, automotive, or similarly regulated field; Minimum 2 years in the medical device industry with experience at all stages of a product lifecycle from ideation to commercialization. The ideal candidate is passionate, driven and motivated to succeed while maintaining a positive team environment.Leadership if any:
Technical oversight and leadership of projects and sub-systems; No direct managerial responsibilities but may be asked to mentor and train junior staff.Travel Requirements:
10-25%, depending on program or phase of program; may require occasional international travel.You. UnlimitedWe believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.Inclusion, Diversity and Equity:
We are committed to welcoming, celebrating and thriving on diversity.Other reasons why you will love it here!Your Future:
401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement.Work/Life Balance:
PTO, Paid Holidays, Flex Holidays, Paid Community Service Day.Your Wellbeing:
Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program.Flexibility:
Hybrid Work Model (For most professional roles).Training:
Hands-On, Team-Customized, Mentorship.Extra Perks:
Discounts on fitness clubs, travel and more.Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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