Sr. Packaging Engineer

Teleflex•Durham, NC

15h•Onsite

About The Position

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 design history files (DHF) or internal SOPs/Work Instructions in compliance with the Teleflex Quality System.

Requirements

Bachelor of Science or Professional Engineer (PE) Certification - Engineering or technical discipline (Packaging Science or equivalent degree).
Minimum 8 years of medical device packaging experience.
Advanced knowledge of ISO11607 standards.
Strong analytical and problem-solving skills.
Medical Device Package design, equipment, and testing knowledge.
Effective verbal and written communication skills.
Team player with good interpersonal skills.
Proficient in Microsoft Office Suite and computerized analysis applications.
Self-motivated, high energy, collaborative, positive attitude individual with the initiative and drive for timely completion of goals.

Responsibilities

Work as a Subject Matter Expert in many aspects of medical packaging.
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.
Lead the redesign of existing packaging systems and manufacturing processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce higher quality 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, manage the design control activities for the new/replacement and existing product packaging and components.
Lead and drive the development/improvement of packaging design & processes by utilizing tools such as DOE and statistical analysis, assist in implementation with appropriate controls and metrics.
Conduct or coordinate package testing in the internal Teleflex Packaging Lab or with external testing service 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.
Lead and support project teams in meeting project objectives, milestones, and target dates. Update and review project progress with leadership.
As requested, work with the Product Performance Team and R&D personnel to lead investigation of product complaints involving packaging to determine the root cause and implement corrective action.
Understand and utilize the requirements of and operate in a medical device manufacturing environment.
Have a strong understanding and skill set in project management and technical writing.
Direct efforts of drafts people, technicians, tradespeople, and lab personnel in the development of packaging related products, processes, test fixtures, equipment, test procedures, and documentation.
Participate and lead design and technical phase reviews.
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 in compliance 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.