Mechanical Design Engineer

Mechanical Design Engineer I

In this role, you will help design, evaluate, and support electromechanical and biotechnology devices from early concept through their full product lifecycle. You will work side by side with a collaborative, cross-functional team that includes Quality Assurance, Regulatory Affairs, Manufacturing, Manufacturing Engineering, and Supply Chain to bring new designs to life and improve existing products.

You will play a key role in solving engineering challenges, supporting design updates, and ensuring products meet performance, quality, and regulatory expectations. This position reports to the Director of Engineering and offers the opportunity to make a meaningful impact on products that move from idea to production and beyond

Requirements:

Bachelor’s Degree in Mechanical Engineering or similar discipline is required
3+ years of mechanical design engineering type experience
Proficiency in SolidWorks is required

Scope:

Responsible for Product Support, Sustaining Engineering, and NPD tasks
Lead Engineering Change Orders (ECOs) within a regulated Quality Management System
Works closely with external vendors, contract manufacturers, and testing laboratories.
Design and develop mechanical components, assemblies, and tooling for new and existing products
Work closely with electrical, software, and manufacturing engineers to integrate mechanical designs into complete medical device systems and production environment.
Evaluate and maintain existing mechanical designs, including drawings, specifications, and BOMs
Perform root cause investigations, support CAPAs, NCMRs, and product improvements
Create 3D CAD models and detailed drawings using SolidWorks. Apply design for manufacturability and assembly principles
Develop and execute test methods to evaluate mechanical performance
Participate in verification and validation activities, including environmental and durability testing
Support Design History Files (DHFs), traceability, and regulatory documentation

This position offers a compensation range between 80,000 – 115,000 base salary. This position is eligible for full benefits (health, vacation, 401k, etc). The company pays 100% of health insurance premiums. Compensation is based on level of candidate experience.

#Onsite

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