NPI Laser Engineer

About the role

AVNA is seeking an NPI Laser Engineer to lead the introduction of new medical‑device products in the laser manufacturing area. You will guide the transition from prototype or external transfer to stable, regulated production, ensuring robust, validated and cost‑effective processes for cutting, welding and marking.

Key responsibilities

• Lead technology transfer of laser‑based products from R&D, customers or headquarters to local production.
• Plan and execute NPI activities, monitor schedules, technical milestones and manufacturing readiness.
• Coordinate production ramp‑up, guaranteeing stability, capacity and compliance with specifications.
• Develop manufacturing, assembly and inspection methods using DFM/DFA principles.
• Design, validate and implement fixtures, tooling and equipment.
• Conduct process and equipment validations (IQ, OQ, PQ) and statistical capability studies (Cp, Cpk, MSA).
• Create and maintain PFMEA, control plans and technical documentation.
• Ensure compliance with GMP, ISO 13485 and FDA regulations, manage deviations, root‑cause investigations and CAPAs.

Required profile

• Bachelor’s degree in Industrial Engineering, Mechanical Engineering or a related field.
• Proven experience in new‑product introduction or laser manufacturing for medical devices.
• Strong understanding of regulatory requirements (GMP, ISO 13485, FDA).
• Ability to lead cross‑functional teams and manage technical documentation.

Required skills

• Laser cutting, welding and marking processes.
• Process validation (IQ, OQ, PQ) and statistical analysis (Cp, Cpk, MSA).
• PFMEA creation and control‑plan development.
• GMP, ISO 13485 and FDA regulatory knowledge.
• Design of fixtures, tooling and equipment.
• Documentation management (DHR, protocols, validation reports).