It takes drive, innovation and hard work to design leading edge medical products that transform the medical industry. We do just that.
In this role, Engineer will use sound and proven engineering principles, best practices and concepts to assist in designing product packaging to ensure product & package integrity is maintained throughout shipping and distribution environment. Testing, analyzing, and selecting materials for packaging based on durability and cost effectiveness. Working as a member of a Packaging engineer team, this engineer will collaborate and communicate with other engineers, management, and operators.
Essential Duties and Responsibilities:
Design, development and qualification of primary, secondary, and tertiary packaging solutions for new company products.
Lead validation & verification of packaging design, processes and equipment to support clinical trials and new product commercialization.
Implement changes to commercial packaging systems as necessary to support corporate objectives. This typically includes identifying requirements, gaining multi-department buy-in, communicating with vendors, updating documentation, and processing through document control system.
Communication and collaboration with packaging vendors on new designs, tooling, and qualification. This includes, as necessary, identifying and onboarding new/secondary suppliers.
Provide technical assistance in scaling up equipment and processes from prototype to pilot to full scale manufacturing.
Develop and maintain technical project timelines and provide updates and feedback to project leadership.
Provide technical oversight and coordinate Research and Development builds within a pilot production facility for multiple projects and project teams.
Develop Packaging design requirement flow down.
Identify project risks and track mitigations through standard methods.
Exercise judgment within defined procedures and policies to determine appropriate action.
This position assumes and performs other duties as assigned.
Demonstrated ability to design, develop and implemented packaging system for sterile and non-sterile per ISO 11607-1/2, ASTM & EN standards.
Exceptional technical writing skills through experience drafting study protocols and reports, validation protocols and reports, and technical analysis position papers.
Proficiency with Medical Device development life cycles and packaging design, processes and technologies preferred.
Demonstrated ability to run self-directed projects, maintain timelines, and execute projects in an R&D environment.
Detail knowledge of selecting packaging material for sterile and non-sterile requiring ESD protection preferred.
Experience in scaling-up from R&D design prototypes to fully automatable commercial packaging systems.
Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
Proven ability to work hands-on in a fast-paced environment.
Detailed oriented with strong time management skills.
Excellent communication (written and verbal) and personal interaction skills.
Familiar with sterile barriers and various sterilization methods and design/process constraints.
Self-starter who is able to formulate and execute a sub-project plan (including estimation of timeline and key milestones) with moderate technical guidance and managerial support.
Self-starter with demonstrated efficient work methods, analytical& problem solving skills and ability to handle multiple tasks in a fast paced environment.
Comfortable in working cross-functionally with all internal departments, team members and outside suppliers.
Strong communication skills with both internal and external contacts.
Excellent attention to detail, especially technical writing.
Proficient in the use of Esko ArtiosCAD and Cape Palletization Software SolidWorks or equivalent CAD software.
Familiar with data analysis methods and analysis software, experience in JMP or Minitab preferred.
Knowledge of Design for Six Sigma and/or Lean Six Sigma will be a plus.
"We Engineer your success" Britech Group, Inc is a Technology Staffing Company who are experts in integrating exceptional people with top companies. Additional Job Openings- http://britechgroup.com