QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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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.

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:

Proficient in CAD, WORD, Excel, MS Project. Working knowledge of Minitab is a plus.

All your information will be kept confidential according to EEO guidelines.