Staff Engineer, Design

Getinge•Wayne, NJ

1d•$115,000 - $135,000

About The Position

The Staff Engineer, Design is primarily responsible for designing and developing new production equipment and tooling to support manufacturing needs, including cost reduction, ergonomic improvements, quality enhancements, and new product introductions. Following equipment deployment, the engineer supports validation activities and assists maintenance/manufacturing teams when validation or maintenance findings require design modifications. This role ensures that equipment designs are robust, well-documented, and compliant with applicable medical device regulations.

Requirements

Bachelor’s degree in Engineering (Mechanical Engineering preferred) or related technical discipline.
8+ years of experience in equipment or tooling design within a manufacturing environment (medical device preferred).
Proficiency in SolidWorks including part/assembly modeling, and drafting.
Hands-on experience with prototype builds, mechanical troubleshooting, and equipment commissioning.
Strong understanding of mechanical systems, pneumatics, electromechanical integration, and manufacturing methods.
Ability to generate and revise engineering drawings, BOMs, and technical documentation.
Excellent communication, collaboration, and time‑management skills.
Strong mechanical design and engineering analysis skills.
Understanding of validation concepts (IQ/OQ/PQ) in a regulated environment.
High proficiency in CAD and supporting engineering software (Excel, Word, PDM, etc.).
Ability to communicate effectively with operators, technicians, engineers, vendors, and management.
Strong problem-solving skills with a focus on robust design solutions.

Responsibilities

Design and develop new production equipment, tooling, jigs, and fixtures that improve manufacturability, efficiency, ergonomics, and quality.
Create detailed SolidWorks CAD models, engineering drawings, and specifications for internal fabrication or external vendor manufacturing.
Lead equipment reviews and incorporate feedback from manufacturing engineering, maintenance, and production operators.
Work with external suppliers and fabrication shops to communicate design intent, resolve build issues, and verify component quality.
Ensure all equipment designs comply with internal engineering standards, safety requirements, and medical device regulations.
Support Manufacturing Engineering and Maintenance teams during equipment validation , installation, and troubleshooting.
Implement and document equipment design modifications based on validation outcomes or equipment performance issues.
Provide updated drawings, documentation, and bills of materials when equipment changes are made.
Assist in preparing capital expenditure documentation for new equipment, including engineering rationale, cost analysis, and recommendations.
Make informed engineering decisions based on analysis, testing, and validated data.
Work independently while collaborating with cross-functional teams.