Sr. Packaging Engineer in Louisville, CO at Apex Life Sciences

Date Posted: 3/27/2018

Job Snapshot

Job Description


The Sr. Packaging Engineer Contractor has the responsibility and authority to provide a lead role in the development, design, and verification of packaging materials/components for medical devices of the Neurosurgery business sector. The Sr. Packaging Engineer Contractor will work from either the Goleta, CA, Jacksonville, FL, or Louisville, CO office. Those working from either the FL or CO office can expect a 50% travel requirement in order to occassionally visit the CA office. There is also the possibility to work remotely from a location of your choice as long as it is close to the Goleta, CA office. This is a 1-year contract.

POSITION RESPONSIBILITIES:
• Lead packaging design verification activities across multiple product families of the Neurosurgery business.
• Lead packaging design change efforts and subsequent verification activities to verify updated packaging. This may include evaluation of new materials for device packaging.
• Leads the development and evaluation of prototypes, facilitates appropriate benchtop testing and performs overall analyses of design options.
• Directs vendor design and development of new packaging and monitors progress to ensure timely implementation of packaging components.
• Develops package testing verification protocols, analyses test data and results, and develops test reports.
• Facilitates or supports manufacturing builds of test samples needed for packaging design verification.
• Creates component specifications and drawings for procurement and inspection of packaging components.
• Facilitates packaging design reviews with cross-functional teams.
• Develops packaging-related documentation supporting product manufacturing such as packaging assembly drawings.
• Trains manufacturing operators on proper packaging assembly.

EDUCATION REQUIRED:
• Bachelor's Degree

       •  Degree in Packaging/Packaging Science is preferred, but not required

YEARS OF EXPERIENCE:
• At least 3+ years of medical device packaging experience

• 5+ years of packaging engineering experience is preferred (this can include pharmaceutical experience)
• Experience working within an FDA-regulated environment is required.

SPECIALIZED KNOWLEDGE REQUIRED:
• Knowledge of FDA and International regulations related to packaging is required.
• Understanding of ISO 11607 (Parts 1 & 2) standards and experience with ASTM 4169 and/or ISTA testing is required.

PREFERRED QUALIFICATIONS:
• Experience in packaging manufacturing operations desired.
• Complete understanding and wide application of technical principles, theories and concepts in the medical device packaging field. General knowledge of other related disciplines.
• Thorough knowledge of FDA and International regulations related to packaging.
• Complete understanding of applicable ISO, ISTA and ASTM test standards and methods related to packaging.
• Strong knowledge of various packaging materials, blister and pouch sealing machinery and sterilization methods of medical devices.
• Strong time management skills.
• Ability to lead, work and communicate effectively with other engineers, designers, packaging users, marketing, regulatory affairs, operations, quality assurance, purchasing, vendors and suppliers to develop packaging solutions.
• Strong problem solving and analytical skills. Ability to define problems, gather data, establish facts, and draw valid conclusions.
• Excellent oral, written communication and presentation skills. Exercises good judgment when communicating to all levels in the business organization.
• Effective use of Microsoft Office applications.

There will be limited OT for this role.

All qualified applicants, please send your up-to-date resume to jhambrose@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.