Staff Engineer, Manufacturing

Location: Onsite

Status Type: Full Time

QUALIFICATIONS

Required:

- Bachelor’s degree in Mechanical Engineering from an accredited university.

- A minimum of 8 years of manufacturing engineering experience in a regulated industry (medical device, pharmaceutical, or similar).

- A minimum of 6 years of experience participating in validation and qualification activities for manufacturing equipment and processes.

- Proven hands-on experience in the design, integration, and implementation of highly automated assembly lines, including robotics, motion control, and inspection systems.

- Demonstrated experience collaborating with cross-functional project teams and automation suppliers.

- Experience with high-volume manufacturing (1M+ units annually, less than 10-second cycle time).

- Strong hands-on experience with automation controls and programming, including Allen-Bradley Programmable Logic Controllers (PLCs), Human Machine Interfaces (HMIs), Supervisory Control and Data Acquisition (SCADA) systems, and data acquisition networks.

- Experience with automated testing, vision inspection, and servo-driven motion platforms.

- Deep understanding of robotic systems (SCARA, Cartesian, and collaborative robots) and industrial networking protocols (EtherNet/IP, OPC-UA).

- Experience with cleanroom manufacturing (International Organization for Standardization (ISO) Class 8) and contamination control strategies.

- Demonstrated ability to optimize Overall Equipment Effectiveness (OEE), line efficiency, and equipment reliability using Total Productive Maintenance (TPM) and Reliability-Centered Maintenance (RCM) methodologies.

- Strong application of Lean manufacturing principles, including value stream mapping, Single-Minute Exchange of Die (SMED), and kaizen facilitation.

Preferred:

- Six Sigma Black Belt (CSSBB) or Certified Manufacturing Engineer (CMfgE).

- Proficiency with SolidWorks, Minitab, PLC programming software (e.g., Studio 5000/RSLogix), and Microsoft Office Suite.

- Experience with digital twin technologies or line simulation modeling for capacity and throughput analysis.

- Knowledge of Good Automated Manufacturing Practice (GAMP) 5, International Organization for Standardization (ISO) 13485, and Title 21 CFR Part 820 for equipment and software validation.

- Robot programming or integration experience with major platforms (e.g., FANUC, ABB, Epson) and/or vendor automation certifications.

Skills & Competencies:

- Proficient in equipment design, validation, and lifecycle management, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

- Advanced skills in process optimization, data analysis, and problem solving.

- Effective communicator with excellent technical writing and presentation skills.

- Strong skills in supplier management and technical coaching.

- Deep understanding of Lean Six Sigma, process capability analysis (Cp, Cpk, Ppk), and Measurement System Analysis (MSA).

- Experience facilitating kaizen events, Design of Experiments (DOE) studies, and Statistical Process Control (SPC) monitoring.

- Understanding of Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, and automation data connectivity for traceability and performance tracking.

- Adaptability and resilience in dynamic, high-volume manufacturing environments.

- Advanced troubleshooting and optimization of PLC, HMI, and SCADA-based control systems supporting automated production equipment.

- Skilled in robot programming, motion control tuning, and vision system calibration for automated assembly and inspection equipment.

RESPONSIBILITIES:

- Design, specify, and implement fully automated assembly and test equipment, including robotics, motion control, and vision inspection systems.

- Program, configure, and troubleshoot PLCs, HMIs, SCADA systems, and robotic controllers supporting automated production lines.

- Lead troubleshooting and continuous improvement efforts for automated equipment to enhance performance, quality, and reliability.

- Execute and support process validation activities (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)) and documentation in compliance with Food and Drug Administration (FDA) and International Organization for Standardization (ISO) standards.

- Develop and implement Standard Operating Procedures, training, and qualification documentation.

- Support relationships with automation suppliers, participate in design reviews, and execute Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs).

- Drive improvements in Overall Equipment Effectiveness (OEE), yield, and efficiency using Lean Six Sigma tools.

- Provide technical guidance and mentorship to engineers and technicians.

- Develop and maintain Quality System documentation related to manufacturing processes and equipment.

- Collaborate with cross-functional teams to deliver automation and manufacturing engineering project goals on time and within budget.

- Support risk management through Failure Mode and Effects Analysis (FMEA) and other preventive quality tools.

Physical Requirements:

- Must be able to remain in a stationary position for extended periods of time.

- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.

- Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time.

- Position requires being physically present on the premises during regular company hours or as approved by management.