Mechanical Design Engineer
On-siteState College, Pennsylvania, United States or Port Matilda, Pennsylvania, United States
Job Summary
Lead mechanical design activities for new product development, product enhancements, and engineering change projects from concept through commercialization. Design innovative laboratory and medical devices that integrate mechanical, electrical, and optical systems while balancing performance, manufacturability, quality, cost, and customer needs. Create and maintain accurate 3D models, engineering drawings, assemblies, tooling designs, and related technical documentation using SolidWorks or equivalent CAD software. Utilize engineering analysis tools, including Finite Element Analysis (FEA), to evaluate product performance, reliability, and durability. Develop, build, and evaluate prototypes while partnering with internal teams, suppliers, and external development partners. Plan and execute engineering testing, verification, and validation activities to ensure designs meet product requirements and applicable regulatory standards. Create and maintain multi-level Bills of Material (BOMs), engineering specifications, and technical documentation throughout the product lifecycle. Support manufacturing through production launches, troubleshooting, root cause analysis, continuous improvement initiatives, and implementation of design improvements. Participate in risk management activities and design reviews to ensure product safety, quality, and regulatory compliance.
Required Qualifications
- Bachelor's Degree in Engineering
- at least 1 year of directly related experience
- Experience designing components using sheet metal, machined parts, injection molded plastics, and other common manufacturing processes
- Working knowledge of engineering standards and regulatory requirements applicable to medical devices (UL, CE, ANSI, ISO, and FDA)
- SolidWorks or similar CAD software
- MS Office Suite products
- Demonstrate a consistent commitment to maintaining a safe work environment for yourself and others
- Follow all company safety policies, procedures, and required personal protective equipment (PPE) practices
- Occasionally lift and move materials weighing up to 50 pounds with or without reasonable accommodation
- Frequent local travel during the business day, mostly between work locations
- Occasional overnight travel may occur
Desired Qualifications
- Experience with embedded electronics or electro-mechanical systems
- MS Project or similar project management tools
- A passion for working in a fast-paced, safety-oriented, mission-driven manufacturing environment
- Strong analytical thinking and structured problem-solving skills
- Ability to manage multiple priorities while delivering high-quality work within project timelines
- Demonstrated ability to collaborate effectively within cross-functional teams
- Curiosity and willingness to continuously learn new technologies, processes, and industry standards
- Strong understanding of mechanical design principles, material selection, manufacturing processes, and product development methodologies
- A continuous improvement mindset with the ability to challenge the status quo and lead change effectively
- Excellent written and verbal communication skills with the ability to explain technical concepts to both technical and non-technical audiences
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