Sr. Engineer

QRC Group, LLC•Humacao, PR

22h

About The Position

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

Requirements

Ability to work independently and develop solutions with minimal supervision.
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.
Ability to manage multiple priorities and project timelines.
Strong communication skills.
Willingness to travel up to 25% (domestic and international).
Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related).
Equivalent hands-on experience may be considered.
Minimum 8 years of engineering experience.
Background in automated manufacturing equipment and high-volume production.
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.
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.
Proficient in CAD, WORD, Excel, MS Project.

Nice To Haves

Experience in tooling design and complex mechanical systems (preferred).
Familiarity with GMP, ISO standards, Lean Manufacturing, and FDA-regulated environments (preferred).
Experience with risk analysis (FMEA) and statistical tools (SPC).
Experience in medical devices, pharmaceuticals, or in-vitro diagnostics (preferred).
Working knowledge of Minitab is a plus.

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.