Staff Engineer

We are seeking a highly skilled and motivated Staff Engineer to join our growing team. This role requires a strong technical foundation, a passion for process improvement, and the ability to collaborate across departments to drive engineering projects to successful completion. The Staff Engineer will be responsible for equipment design and optimization, executing validation protocols, leading process improvement initiatives, and supporting cost-reduction efforts. This is a key position for driving continuous improvement and ensuring that our engineering operations comply with regulatory standards.

Key Responsibilities:

· Technical Expertise

• Proficiency in reading and interpreting engineering prints, with a strong understanding of Geometric Dimensioning and Tolerancing (G, D, & T).

· Process Improvement & Lean Principles

• Lead and participate in Kaizen events and other continuous improvement initiatives.
• Apply structured problem-solving methodologies to resolve complex technical issues.
• Project Management - Utilize basic project management skills to plan, organize, and execute engineering projects, including cost reduction and process optimization initiatives.

· Equipment Design & Optimization

• Design, modify, and optimize manufacturing equipment to improve productivity, reduce costs, and enhance reliability.
• Manage equipment projects from concept through implementation, ensuring alignment with production requirements.

· Validation & Compliance

• Develop and execute validation protocols for new processes, equipment, and products, ensuring compliance with regulatory standards.
• Maintain a deep understanding of relevant regulatory compliance(e.g., FDA, ISO), ensuring that all engineering practices meet industry standards.

· Collaboration & Teamwork

• Work effectively within a team environment, supporting peers and cross-functional teams to achieve shared goals.
• Communicate technical information clearly and effectively to both technical and non-technical team members.

Qualifications:

· Bachelor’s Degree in Engineering (Mechanical, Electrical, Industrial, or related field).

· Proficiency with CAD software and basic design tools. (Solidworks Preferred)

· Experience with developing and executing validation protocols in regulated environments.

· Basic project management skills with the ability to balance multiple initiatives simultaneously.

· Strong analytical and statistical skills for data analysis and process optimization.

· Strong ability to understand and establish Design Intent.

Preferred Experience:

· Experience working in a regulated industry (e.g., medical devices, automotive, aerospace).

· Previous involvement in Kaizen events and other continuous improvement initiatives.

· Experience managing projects with an emphasis on cost reduction and equipment optimization.

Working Conditions:

• This is a Salaried, exempt position that will require occasional evening work, correspondence with customers, distributors, and regulatory bodies outside of normal working hours.
• Travel not to exceed 20%
• Must be eligible to work in the U.S. and provide proper documentation within 3 days of employment
• Must successfully pass background screening and drug screening

Physical Requirements

• A candidate may need to occasionally push, pull, or lift 25-50 lbs.
• Frequent walking, standing, or sitting for extended periods of time.