MANUFACTURING ENGINEER II

Job Overview

Responsible for the control and improvement of manufacturing processes, ensuring compliance with industry standards and product quality.
Key functions include: Regulatory Compliance, Quality Assurance, Implementation of New Technologies and Methods for Improvement, Interdisciplinary Collaboration, Process Optimization, Technical Problem Solving, and Technological Updates. The engineering department in the medical industry plays a critical role in advancing healthcare by ensuring the safety and effectiveness of products reaching the market, thus contributing to patient well-being and medical progress.

Job Requirements

• Apply extensive knowledge of a specific professional discipline to solve moderately scoped problems requiring analysis of various factors.
• Deliver results aligned with specific objectives supporting departmental goals; judgment errors or failure to achieve results may cause delays, costs, and disruptions.
• Participate in setting assignment objectives.
• Collaborate with colleagues and peers.
• May train other employees.
• Demonstrate broad knowledge of theory and principles within a professional discipline.
• Apply skills and knowledge to understand specific needs or requirements.
• Analyze information and generate ideas.
• Develop solutions to moderately complex problems.
• Identify and correct non-obvious issues in existing systems or processes.
• Sustain, control, and improve manufacturing processes to ensure efficiency and product quality.
• Identify continuous improvement opportunities and propose/implement solutions.
• Execute, write, and review medium-complexity validation protocols.
• Create and update medium-complexity validation Gantt/Plans, support ME I.
• Participate/Execute/Lead medium-complexity improvement projects.
• Ensure manufacturing processes comply with industry standards like GMP and ISO 13485.
• Select medium-complexity tools or fixtures to ensure product consistency and quality; validate equipment (excluding TMVs) in established processes (not for new product/process transfers).
• Improve medium-complexity process fixtures/tools; support operations with tools/fixtures as needed.
• Include new tools/fixtures in the Calibration System.
• Provide initial recommendations for process consumables with ID, description, and Min-Max.
• Support investigations of over-consumption (led by Operations, at least initially).
• Identify, investigate, and support manufacturing issues like quality defects or variations.
• Support or create process deviations led by Quality.
• Lead/support/execute process problem-solving (medium complexity), including necessary actions.
• Maintain accurate and detailed process documentation (Methods, Instructions, Forms, Procedures).
• Use change control systems (SmartSolve) to ensure process integrity and history.
• Approve Change Plans.
• Objectively review submitted changes to minimize process impact, with Core Team if needed.
• Update BOM/Method based on process improvements or analysis; initial method defined by transfers or NPI/NPD.
• Support investigations of BOM item overuse (led by Operations, at least initially).
• Update/support PFMEA modifications based on process changes (initial PFMEA comes from NPI/NPD).
• Collaborate with departments like Operations, Quality, Logistics, and Project Management to ensure consistency and efficiency across the supply chain.
• Support NPI in understanding and responding to RTS regarding current process capabilities.
• Train designated Operations trainers on updated processes and standards, if applicable.
• Evaluate and manage EHS risks related to processes, machinery, or tools to ensure ergonomics, safety, and product quality.
• For new equipment acquisition: quote (with minimal supervision), verify (FAT), and validate (IQ) risk assessments based on TEC-124-98 and TEC-124-118.
• Evaluate and implement new technologies/methodologies to improve manufacturing efficiency and quality (low to medium complexity, minimal supervision).

What your background should look like

• Experience:
  Minimum 3 years of experience in a production environment.
  At least 3 years of supervisory experience in manufacturing settings.

• Skills:

  • Adaptability to change
  • Effective and positive communication with all departments and management
  • Problem-solving skills
  • Critical and analytical thinking
  • Statistical analysis
  • Continuous learning adaptability
  • Experience in technical documentation (SOP, IQ, OQ, PQ)
  • Process optimization techniques
  • Knowledge of mechanical design software (SolidWorks, AutoCAD) – Desirable
  • English level B2 – Desirable
  • Availability for overtime work
  • Responsibility and discipline in fulfilling work hours
  • Knowledge of problem-solving tools (DMAIC, RCA, A3, PDCA)
  • Knowledge of ISO 9001, 13485 standards – Desirable

• Special Certifications:

  • Passport and U.S. Visa – Desirable
  • Knowledge of medical device manufacturing processes or related – Desirable
  • Lean Manufacturing and Six Sigma – Desirable

Competencies