Position Summary

Join a dynamic R&D team developing innovative medical devices that transform patients' lives. As a Senior Design Engineer, you’ll collaborate with cross-functional teams, including Quality, Biomechanical Testing, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to drive successful product development.

Focusing on the Foot & Ankle/Lower Extremities market, you'll design, develop, and validate mechanical components and subsystems, working from concept to product launch. Through customer research and direct interactions, you'll gain insights to create solutions that make an impact in shaping the future of orthopedic care.

If you're passionate about engineering, problem-solving, and improving patient outcomes, we want you on our team!

What you will do:

Under minimal supervision, research, design, develop, modify, and verify components/modules for medical devices
Translate design inputs to engineering specifications and produce sub-system level designs
Develop and analyze solutions, prototyping one or more options to provide proof of concept
Apply fundamental and some advanced concepts, practices and procedures for problem solving
Demonstrate advanced understanding of customer needs and design inputs
Demonstrate proficiency with product’s intended use and clinical procedures
Learn how the financial models are constructed
Follow fundamental industry standards, design requirements and test strategies which apply to regulatory requirements
Independently create or refine engineering documentation, such as the Design History file
Follow R&D procedure like design controls and risk management, per the Quality Management System
Under minimal supervision, work with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success
Quickly process and assimilate procedures, policies, processes, systems, and technology required
Work on complex problems, applying advanced experience and learnings
Demonstrate ownership and prioritize work with minimal supervision
Works as key member of the team, collaborating with others and solidifying relationships

What you will need:

Bachelor of Science in Engineering, Mechanical Engineering or BioMedical
2+ years of work experience
Working knowledge and understanding of mechanical engineering practices and design principles
Technical ability to create engineering drawings and models, applying GD&T and CAE tools (Solidworks/Creo etc)
Demonstrated ability to apply knowledge of materials and manufacturing processes to product design
Ability to read and interpret complex drawings
An understanding of Finite Element Analysis (FEA) and its application
Experience in design controls and risk management within a regulated industry
Good problem solving and trouble shooting skills (Ability to work through each problem, use case, etc., and find the root cause, then provide potential solutions; methodical).
Ability to Communicate basic plans and technical information to team members
Experience and hands on with design tools like Creo, Windchill, release of design through change management.

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Travel Percentage: 20%

R&D Design Engineer

Job Description