Packaging Engineer - Urgent need

Job Description

The individual in this position will be a Packaging subject matter expert (SME) to provide support for design, development, verification, and validation of sterile medical device packaging (e.g., sterile barrier systems) under the Enterprise Cost-To-Win (eCTW) Program for the client.

Works under general direction to guide design and development of sterile medical device packaging (e.g., sterile barrier systems) that are needed to meet the business' Enterprise Cost-To-Win (eCTW) objectives, covering a multitude of cost-savings and continuous improvement initiatives around device packaging and associated processes.

Act as Packaging subject matter expert on cross functional teams to drive Packaging strategy and alignment to best practices and at times will function in a project leadership role.

Qualifications

• Strength in scientific and engineering fundamentals based on first principles understanding including critical thinking and systematic problem-solving skills as well as business acumen and learning agility are essential requirements to be successful in this position.
• Working knowledge of packaging industry standards and regulations, including: Packaging Engineering Design (medical device sterile packaging design), Packaging materials (flexible and rigid) & sterilization processes, Packaging Testing methods, Labeling Testing methods (PTS), High volume regulated manufacturing, ISO-11607/ASTM D4169, ISO 13485/21 CFR Part 820.
• Experience with forming/sealing process and tooling for hard and soft blister packs, web materials made of thermoplastics and reinforced paper, shrink wraps, flow wraps, automatic case carton erection, labeling (materials, adhesives, inks/printing, etc.), UDI compliance and barcode printing/decoding are all strongly preferred.
• Strong technical judgement and leadership skills.
• Product development considerations for tightly controlled high-volume manufacturing process.
• Disciplined in phase-gate product development and project planning.
• Strong project management, prioritizing, and multi-tasking skills to work within tight deadlines.
• Understanding of Measurement Systems Analysis (MSA).
• Proficiency with statistical methods including DoE and data analysis using software such as Minitab.
• Proficiency in solid CAD modeling (Creo, SolidWorks or equivalent) and design for manufacturability including injection molded and related systems and assemblies.
• Proficiency with fixture design including basic machining considerations and developing test methods (fixture design and hands-on testing).
• Proficiency with TOPS (or similar pallet configuration tool) is a plus.
• Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies.
• R&D functional planning, requirement generation and technical (DFSS/Design/Cross functional) reviews for all product development phases.
• Certified Packaging Professional through the Institute of Packaging Professionals is strongly preferred.