Senior Manager, Package Engineering

Globus Medical • Audubon, PA

5d

About The Position

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.

Requirements

• Bachelor degree in a technical field: Engineering, Science, or biomedical engineering.
• 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

Nice To Haves

• Master degree in Science is a plus.
• Other relevant fields of study are accepted and will be considered.

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior