Our client is the leading developer of a diabetes management device designed for simplicity, for those who want an insulin pump that removes complicated technology and allows for a smooth transition from manual injections. We are dedicated to helping people with diabetes gain access to high-quality care by making it affordable and easy to use. This is an exciting time and as our Sr. Mechanical Engineer, you will kick off the design improvement process as our product travels the path of commercialization.
ROLE AND RESPONSIBILITIES:- Team: As a hands-on Sr. team member, you will participate in hands-on design and improvement of mechanical systems, components, and assemblies for medical devices. You will incorporate principles of engineering design, materials science, and manufacturing processes, and inspire a small team of mechanical engineers, fostering a culture of innovation, collaboration, and continuous improvement.
- Project Management: Participate in planning, execution, and delivery of mechanicalengineering projects, ensuring adherence to timelines, budget constraints, and qualitystandards from design change to manufacturing.
- Mechanical Design: Provide technical expertise in the design and improvement of Mechanical components, assemblies, and test fixtures using SolidWorksDesign for Reliability: Strong Knowledge of HALT testing and accelerated aging Testing. Ability to rapidly prototype and evaluate designs. Problem Solving: Developing and executing plan for solving of complex design problems. Delegating sub-problems and guiding Jr. Engineers on solving problems.
- Engineering Analysis: Conduct engineering analysis, simulations, and testing to evaluatethe performance, reliability, and safety of mechanical designs, identifying opportunities foroptimization and enhancement.
- Regulatory Compliance: Ensure compliance with relevant regulatory standards andrequirements (e.g., FDA regulations, ISO standards) throughout the product developmentlifecycle, maintaining accurate documentation and records.
- Risk Management: Identify and mitigate risks related to mechanical engineeringactivities, proactively addressing technical challenges and ensuring the successfulresolution of issues.
- Communication: Effectively communicate project updates, technical findings, andstrategic recommendations to senior management, cross-functional teams, and externalstakeholders as needed.
QUALIFICATIONS AND EDUCATION REQUIREMENTSBachelor’s degree in mechanical engineering or related field.8-10+ years of experience in the medical device industry, with a strong track record ofsuccessfully collaborating on small teams as a hands-on individual contributor.
High level of proficiency with SolidWorks.
High level of proficiency with Minitab
Proficiency with Python scripting in order to collect real-time pressure values alongside environmental and device health metrics in accordance with design change.
Experienced with a wide breadth of Medical Device development design issues.
Thorough understanding of regulatory requirements for medical devices.
Must have experience with plastic injection-molded parts at micron level. Microfluidics Design an added benefit.
Must have experience with Stress Analysis, Stack Up Analysis at Micron level. Must have the ability to work with the team to write and execute test protocols.
Must have experience with 5S, Fishbone, 5Y (5 Whys), and Fortree (Fault Tree Analysis)methodologies. Demonstrated Small Medical Device design experience and ability to share images of products designed.
