Principal Mechanical R&D Engineer

Individual contributor who leads mechanical and electromechanical design for medical device development programs. Hands-on technical leader with strong mechanical aptitude, advanced SolidWorks capability, and practical injection molded plastic part design experience. Guides complex designs from concept through launch while mentoring engineers, improving design quality, and supporting manufacturable, reliable, and compliant products.

Responsibilities

• Lead mechanical architecture and detailed design of electromechanical medical device systems, mechanisms, housings, plastic components, and assemblies.
• Create, review, and release production-intent CAD models, assemblies, and engineering drawings using SolidWorks and applicable drafting standards, including GD&T.
• Apply design-for-manufacturing principles for injection molded plastic components, including draft, wall sections, ribs, bosses, snap-fits, parting lines, gating considerations, shrinkage, ejection, and cosmetic requirements.
• Lead technical reviews, tolerance analysis, design risk assessment, DFMEA input, root-cause investigations, and engineering change activities.
• Collaborate with Quality, Regulatory, Manufacturing Engineering, Operations, Marketing, Supply Chain, suppliers, molders, toolmakers, and contract manufacturers.
• Support prototype builds, verification and validation testing, reliability activities, production transfer, and launch readiness.
• Act as a technical mentor for engineers and designers in mechanical design, SolidWorks modeling discipline, drawing quality, GD&T, DFM, and production-focused problem solving.

Requirements

• Bachelor's degree in mechanical engineering or similar preferred; advanced degree desired.
• Preferred certifications: DFSS, SolidWorks (CSWA, CSWP, etc.).
• 4+ years of relevant mechanical or electromechanical product development experience.
• Advanced SolidWorks skills required.
• Knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, and GMP standards preferred.
• Strong mechanical aptitude with demonstrated ability to solve complex mechanism, assembly, tolerance, material, manufacturing, and system integration problems.
• Experience with motor integration, torque analysis, mechanism design, drive systems, durability, reliability, DOE, and test method development preferred.
• Significant injection molding experience, including production-intent plastic part design and direct interaction with tooling, molding, or manufacturing partners.
• Experience with supplier collaboration, first article inspections, process validation support, and production transfer.
• Experience creating engineering drawings and applying GD&T and tolerance analysis to support robust product performance.
• Ability to work independently, influence technical direction, mentor others, and communicate complex technical concepts clearly to technical and non-technical audiences.

Pay

Anticipated salary range: $94,900 - $135,600. Bonus eligible: No.

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs