Current Openings

Auxein has lots of great opportunities and offers a great work environment, professional development, challenging careers, and competitive compensation

Senior Regulatory Affairs Associate

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

  • 5-8 yrs of working experience in Medical Device Regulatory Affairs
  • Knowledge of MDD 92/42/EEC & 21 CFR, Subchapter H
  • Knowledge of ISO 13485 & 21 CFR 820
  • Knowledge of all applicable medical device directives and FDA regulations on orthopedic implants, external fixators and surgical instruments.
  • Preparation of EU technical files.
  • Preparation of US regulatory submission files
  • Preparation of Clinical Evaluation Reports
  • Role in PMS & PMCF of devices
  • Review Labeling
  • Registration Dossiers and submissions in various countries other than EU region and US.
  • Provide Regulatory review of customer complaints
  • Ensure all regulatory requirement compliance on Design & Development team.
  • Work with regulatory affairs consultants when required.
  • Other duties & responsibilities assigned.
  • Good scientific assessment and writing skills.
  • Competency in medical/regulatory terminology.
  • High level of accuracy and attention to details.
  • Time and project management skills with ability to prioritize tasks.

VMC Programmer Cum Manager (MALE Married)

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

  • VMC 5 Axis and 7 Axis programming experience minimum 10 years.
  • VMC setting experience.
  • Starting work from operating of machines.
  • Stainless steel cutting experience.
  • Tools and dies molds and fixtures machining experience.
  • 3D designing experience minimum 5 years on UG NX and Solid Works and Cimitron and Power shape.
  • 3D Modeling surfacing and CAD Data and scan data working experience.
  • Programming 5 Axis experience on Power mill and Solid cam.
  • Worker handling experience.
  • Setters Handling.
  • Post processors making experience.
  • First part approval knowledge.
  • Leadership quality.
  • Production Documentation experience.
  • Machine maintenance experience.
  • Quality inspection experience.
  • Renishaw probing experience.
  • Inspection machine CMM and VMM and Profile projector work experience.
  • Reverse engineering experience.
  • Manual Software programing experience only POWER MILL DELCAM and SOLIDCAM.
  • Threading programming experience.
  • 3D scanning reverse engineering experience.
  • Minimum Diploma holder in Mechanical Engineering.
  • Manual Programing G codes.
  • MAZAK control and SIEMENS and HAAS and Fanuc control experience must.
  • Excellent communications skills: interpersonal, listening, oral, and written.
  • Familiar with programming on VMC 5 Axis related to aerospace parts or
  • Ideally located within easy local.
  • Strong background in programming complex 5 Axis details in hard and soft metals.
  • Industry experience – Aerospace (ideal), Nuclear, Medical or Automotive (high end), Motorsport.
  • 5 Axis VMC and 5 Axis CNC mill Programmer- experience must of CNC and VMC SETTER, CNC MACHINIST, Precision Engineering, Aerospace, Military, CNC Mill Turn, DELCAM, Offline Programming…
  • Salary Upto 1,00,000-/

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