Associate Packaging Engineer

Position Summary

Responsible for and/or assist in the design, testing and validation of sterile and non-sterile packaging for medical products for the Global Teleflex Packaging team. Package design activities include risk analysis, design input, design output, design verification and validation, and design transfer per the Teleflex Design Control policies and procedures, and adherence to all applicable global package integrity and protection standards. Support process development, validation and implementation activities within Teleflex manufacturing sites, contract manufacturers or strategic suppliers as required. Assist or lead updates to the product device master records (DMR), design history files (DHF) or internal SOPs/Work Instructions in compliance with the Teleflex Quality System. 

Principal Responsibilities

•    Assist or work with cross-functional teams to develop medical device packaging, specifications and processes with input from the packaging industry, physicians, marketing and manufacturing adhering to the design control process. 
•    Aid redesign of existing packaging systems and manufacturing processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner.  
•    Interface with suppliers, Strategic Sourcing, R&D, Marketing, Quality and Regulatory Affairs to deliver projects.
•    For in-house manufactured and purchased packaging systems/components, assist in the design control activities for the new/replacement and existing product packaging and components.
•    Assist with and coordinate the development/improvement of packaging design & processes by utilizing tools such as DOE and statical analysis; assist in implementation with appropriate controls and metrics.
•    Conduct or coordinate package testing in the internal Teleflex Packaging Lab or with external testing services providers.
•    For both in-house and purchased packaging systems/components, coordinate the transfer of parts, assemblies, documentation and processes from prototype stage, through pilot to production. Generate product, process and experimental activity specifications for the Device Master Record as required.
•    Aid the project teams in meeting project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
•    As requested, work with the Product Performance Team and R&D personnel to lead investigation of product complaints involving packaging to determine root cause and implement corrective action.
•    Learn the requirements of and operate in a medical device manufacturing environment.
•    Learn the best practice and develop skills in project management and technical writing.
•    Direct efforts of draftsmen, technicians, tradesman, and lab personnel in the development of packaging related products, processes, test fixtures, equipment, test procedures and documentation.
•    Participate in design and technical phase views.
•    Support packaging assessments, review of industry standards updates, product regulatory submissions and/or limited market evaluations/clinical trials as required.
•    Ensure projects are developed and documented compliant with the Teleflex Quality System.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    Bachelor of Science or Professional Engineer (PE) Certification – Engineering or technical discipline (Packaging Science or equivalent degree).
•    0-2 years of relevant experience (product design, machine design, manufacturing processes, medical device and/or pharmaceutical – e.g. Must have Co-op/Internship, general work).
•    Strong analytical and problem solving skills.
•    Package testing and design knowledge.
•    Effective verbal and written communication skills.
•    Team player with good interpersonal skills.
•    Proficient in Microsoft Office Suite and computerized analysis applications.
 

Specialized Skills / Other Requirements

•    Self-motivated, high energy, collaborative, positive attitude individual with the initiative and drive for timely completion of goals.
•    Able to travel domestically and internationally.
 

#LI-DR1