Manufacturing Engineer - Orthopedic Implant and Instruments

Job Purpose:

To lead, optimize, and continuously improve manufacturing processes for orthopedic surgical instruments and implants. The role involves supporting new product introductions (NPI), commissioning advanced manufacturing technologies, and driving process excellence through digital transformation, Lean, and Six Sigma methodologies to ensure compliance with ISO 13485 and global medical device standards.

Key Responsibilities:

1. Manufacturing Operations

• Lead daily production activities with a focus on

  machine utilization, predictive maintenance, and OEE improvement

  .
• Supervise precision manufacturing operations involving

  multi-axis CNCs, robotic polishing arms, laser marking, Ultrasonic cleaning and clean room operations.

• Drive

  structured preventive maintenance

  and maximize uptime using

  CMMS or equivalent platforms

  .
• Develop and maintain

  SOPs, process flow diagrams, and work instructions

  in line with QMS and EHS standards.
• Monitor key process metrics and initiate improvement projects for productivity, yield, and cost optimization.

2. New Product Introduction (NPI)

• Partner with

  R&D, Quality, and Supply Chain

  to ensure seamless industrialization of new products.
• Participate in

  DFM (Design for Manufacturability)

  reviews, prototype builds, and validation activities (

  IQ/OQ/PQ

  ).
• Design and validate

  tooling, fixtures, and gauges

  to support new product launches.
• Conduct

  process capability studies

  and ensure manufacturing readiness before product release.

3. New Machine Setup & Technology Commissioning

• Evaluate and lead commissioning of next-generation production technologies

  , including:

• High-speed CNCs with remote diagnostics

• Automated deburring and polishing systems

• IoT-based environmental monitoring for cleanrooms

• Plan and execute

  machine installation, qualification, and handover

  (FAT, SAT, IQ, OQ).
• Coordinate with

  suppliers, utilities, and validation teams

  to ensure timely commissioning.
• Conduct training for operators and ensure safe, efficient operation of new lines.

4. Process Improvement & Digital Transformation

• Implement

  Lean, Six Sigma, and TPM

  principles to eliminate waste and enhance process capability.
• Champion digital manufacturing initiatives such as

  digital batch records, QR-coded material tracking, and automated process control systems

  .
• Lead

  continuous product and process improvement

  using structured

  CAPA systems and root cause analysis

  .
• Drive

  data-driven decision-making

  through performance dashboards and real-time process monitoring.

5. Documentation & Compliance

• Maintain process documentation, validation protocols, and change control records.
• Support

  internal, customer, and regulatory audits

  (ISO 13485, GMP).
• Ensure

  EHS compliance

  and adherence to medical device manufacturing standards.

Key Skills & Competencies:

• Strong command over

  CNC technology, automated polishing, laser systems, and packaging automation

  .
• Familiarity with

  implant-grade material specifications (ASTM F136, F138)

  .
• Hands-on experience with

  Industry 4.0 technologies, IoT integration, and data analytics

  .
• Proficiency in

  ERP/MRP systems

  (SAP, Oracle, JD Edwards); working knowledge of

  MES/SCADA

  is a strong advantage.
• Ability to lead a

  unionized workforce

  and manage

  multidisciplinary teams

  with agility, discipline, and accountability.
• Strong communication, analytical, and problem-solving skills with a continuous improvement mindset.