- Design Controls
- Six Sigma Certification
- ISO 13485
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
The Packaging Engineer I will work within the Integra Lifesciences CSS Engineering organization to support the packaging requirements of new and existing products. This position will provide technical expertise in the areas of medical device packaging design & development and process development & validation for new packaging equipment.
Works with Engineering and Manufacturing product teams to develop and implement new device packages, to improve existing package designs, to mitigate problems in CSS’s current products, and to develop and improve packaging-related manufacturing processes in the CSS manufacturing plants and at supplier locations.
Works in compliance with GMP work practices, ISO13485, and ISTA Standards.
Participates as the team member responsible for packaging on New Product Development projects and Packaging Development projects.
Participates in risk assessments and cost improvement initiatives.
Partners with Manufacturing, Quality, R&D and Procurement to develop and improve packaging designs that are compliant to all containment and shipping needs of medical devices.
Participate in projects that involve cross-functional teams as the owner of all packaging related deliverables.
Travels as needed to domestic and international vendor sites and company locations
Bachelor of Science degree in Engineering required, Packaging Engineering degree preferred
0-2 years of experience in medical device packaging engineering
Medical device industry product design and validation process knowledge
Knowledge of sterile packaging material characteristics and validation practices
Experience in writing and executing design, equipment, and process validations
Knowledge of ISO13485 Design Control and ISTA Standards with application to medical devices
Experience in supplier selection/management for medical device packaging components and equipment
Statistical analysis knowledge required; Six Sigma certification preferred
Experience working in integrated cross-functional product development teams
Strong technical communication skills
Excellent verbal, written and presentation skills
Demonstrated experience molding technologies and their application in the medical device field.
A thorough knowledge of medical device design control process.
Proficiency in 3D CAD software and molding simulation tools
Ability to communicate effectively with colleagues, teams, management and external partners.
Ability to collaborate with and mentor technical staff in molding engineering discipline.