Summary

Globus Medical, Inc. is a leading publicly traded orthopedic medical device company headquartered in Audubon, Pennsylvania, founded in 2003. The company specializes in the design, development, and commercialization of innovative musculoskeletal solutions that enable surgeons to promote healing in patients with musculoskeletal disorders. Globus Medical has established itself as the fastest growing company in the history of orthopedics through its single-minded focus on advancing surgical technologies. The company's comprehensive product portfolio includes spinal implants, trauma solutions, artificial joints, and the revolutionary ExcelsiusGPS surgical robotic system for spine surgery. Their robotic navigation technology provides sub-millimeter accuracy for transpedicular drilling and screw placement procedures. Globus Medical also offers advanced surgical planning software and registry solutions like SpineTRACK and OrthoTRACK for comprehensive treatment outcomes data collection. The company's mission is to utilize superior engineering and technology to achieve pain-free, active lives for all patients, driving significant technological advancements across a complete suite of orthopedic products.

Job description

Essential Functions

Lead the sterile barrier packaging design and development for Musculo-skeletal implants.
Provide guidance on process validation activities (for both new packaging configurations and packaging production lines).
Develop and adhere to the framework for packaging design and development based on a product development process
Lead and support supplier- and site-initiated material device and packaging component changes.
Perform transportation studies to confirm that the designed packaging and device configuration protects the finished Medical Devices during various phases of the supply chain cycle.
Coordinate root cause investigations and provide solutions using problem solving skills to improve manufacturing reliability & compliance
Maintain a partnership with various stakeholders, other manufacturing sites and suppliers for changes to packaging and device components.
Provide mentorship to mid-level engineers on various aspects of packaging engineering

Qualifications

Education

Bachelor degree in a technical field: Engineering, Science, or biomedical engineering. Master degree in Science is a plus.
Other relevant fields of study are accepted and will be considered.

Experience and Skills

Required

7-10 years oven experience in a Medical device (or equivalent regulated) packaging engineering design and development environment.
Working knowledge of ISO 11607 (parts 1 & 2) standards. Ability to apply the standard to various project scenarios to come up with best possible outcomes.
Understanding of medical device design controls per the ISO 13485 standard.
Working knowledge of the full suite of ASTM tests for medical device packaging verification and validation.
2+ years of experience in working at a packaging engineering test lab.
Strong interpersonal and communication skills in English to be able to effectively collaborate with operators and both global and local colleagues
Ability to work independently and as part of a team.
Strong analytical skills

Requirements

Bachelor degree in a technical field: Engineering, Science, or biomedical engineering
7-10 years of experience in a Medical device (or equivalent regulated) packaging engineering design and development environment
Working knowledge of ISO 11607 (parts 1 & 2) standards
Understanding of medical device design controls per the ISO 13485 standard
Working knowledge of the full suite of ASTM tests for medical device packaging verification and validation
2+ years of experience in working at a packaging engineering test lab
Strong interpersonal and communication skills in English
Ability to work independently and as part of a team
Strong analytical skills

Company overview

Globus Medical, Inc. is a leading publicly traded orthopedic medical device company headquartered in Audubon, Pennsylvania, founded in 2003. The company specializes in the design, development, and commercialization of innovative musculoskeletal solutions that enable surgeons to promote healing in patients with musculoskeletal disorders. Globus Medical has established itself as the fastest growing company in the history of orthopedics through its single-minded focus on advancing surgical technologies. The company's comprehensive product portfolio includes spinal implants, trauma solutions, artificial joints, and the revolutionary ExcelsiusGPS surgical robotic system for spine surgery. Their robotic navigation technology provides sub-millimeter accuracy for transpedicular drilling and screw placement procedures. Globus Medical also offers advanced surgical planning software and registry solutions like SpineTRACK and OrthoTRACK for comprehensive treatment outcomes data collection. The company's mission is to utilize superior engineering and technology to achieve pain-free, active lives for all patients, driving significant technological advancements across a complete suite of orthopedic products.