We are seeking an experienced Engineer to support the design, development, and integration of automated assembly and packaging equipment in a regulated manufacturing environment.

Key Responsibilities

Assist in developing User Requirement Specifications (URS) and mechanical/electrical designs for equipment.
Support equipment integration, including FAT, SAT, installation, and startup .
Ensure equipment and process designs meet product, safety, and operational requirements .
Collaborate with vendors and suppliers on capital projects , managing scope, cost, and timelines.
Support vendor contracts in partnership with procurement and legal teams.
Develop or obtain CAD models and technical drawings (2D/3D).
Maintain design documentation (URS, assembly instructions, bills of process, etc.).
Optimize equipment for efficiency, cost, manufacturability, and ease of operation/maintenance .
Participate in design reviews, risk assessments, and FMEA activities.
Work with manufacturing teams to build, test, and improve prototypes .
Perform or support engineering analyses (stress, thermal, fluid, etc.).
Collaborate with cross-functional teams (engineering, maintenance, etc.) for system integration.
Ensure compliance with safety, quality, GMP, and regulatory standards .

Requirements

Minimum Qualifications

Ability to work independently and develop solutions with minimal supervision.
Experience in tooling design and complex mechanical systems (preferred).
Knowledge of PLC programming and controls .
Proficiency in AutoCAD and/or SolidWorks .
Strong skills in project management, organization, and planning .
Experience with problem-solving and data analysis .
Familiarity with GMP, ISO standards, Lean Manufacturing , and FDA-regulated environments (preferred).
Experience with risk analysis (FMEA) and statistical tools (SPC) .
Ability to manage multiple priorities and project timelines .
Strong communication skills.
Willingness to travel up to 25% (domestic and international).

Education

Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related).
Equivalent hands-on experience may be considered.

Experience

Minimum 8 years of engineering experience .
Background in automated manufacturing equipment and high-volume production .
Experience in medical devices, pharmaceuticals, or in-vitro diagnostics (preferred).
Proven experience in:
- Process improvements
- Equipment implementation and validation
- Full project lifecycle (scoping, budgeting, vendor management, installation, validation)
Knowledge of labeling, barcode systems, and packaging cost analysis .

Physical Requirements

Ability to sit or work on a computer for extended periods (up to 8 hours).
Ability to stand for long periods during testing, FAT/SAT, and troubleshooting.
Ability to move within manufacturing environments (climbing, squatting, etc.).
Must comply with PPE and GMP requirements in a regulated facility.

Special Skills:

Sr. Engineer