Principle Packaging Engineer

Company: Accelus
Location: Louisville
Posted on: May 16, 2022

Job Description:

Summary/Objective The Principle Packaging Engineer is a key leadership position in the Accelus product development team. He/she will be responsible for completing tasks which support the day-to-day operations and strategic projects to the business. General responsibilities include packaging/manufacturing process evaluation, troubleshooting and support of in-house packaging/labeling/sealing equipment of products and processes. Conduct engineering studies and analyzing results to support process validation. Provide engineering support for production packaging/assembly equipment, methods and process validation of new and existing products across sites. Collaborate on project teams to develop high quality, high reliability, and highly manufacturable packaging for medical devices at Accelus. Work under the direction of the Senior Director of R&D in a fast-paced environment supporting program initiatives and compliant with company best practices. ESSENTIAL FUNCTIONS: Contribute to continuous improvements in overall product cost and quality. Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration. Maintain documentation associated with packaging/manufacturing processes. Provide technical support for production packaging/labeling tools and software including assembly/sealing equipment and automation. Participate on projects to concurrently develop packaging assembly methods, tooling, equipment and processes for new and existing products. Partner with Manufacturing to develop lean principals to implement solutions for product packaging, labeling and sealing/assembly. Create standardized work and process maps that result in an optimized production system and extended value stream. Conduct, coordinate and aid in formal Process Validations including protocol development and execution. Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities. (IQ, OQ, PQ) Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR's and CAPA. Complete on time project updates, development plans, self-assessments, and successful completion of all training requirements. Application of statistical and analytical methods such as SPC, SQC and DOE. Contributor to the Capital Expense Request (CER) process, specify cost for packaging/labeling/sealing equipment with consideration to product standard cost targets and capacity demands. Daily activities may include: Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of sterile and non-sterile products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering. Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques. Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants. Nice to Have: Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering. Dynamic, positive attitude Strong communication, manufacturing process, product industrialization and leadership skills. Solid design, troubleshooting and presentation skills Certifications in Lean Manufacturing and/or 6 Sigma Knowledge of GD&T Knowledge of DFMEA and PFMEA Strong Project Management Skills Knowledge and Experience with packaging, assembly and manufacturing methods/equipment (ie: Sencorp bar sealers, Alloyd blister sealers and material sealing of PETG to tyvek, foil to tyvek, foil to foil, mylar to Tyvek) and Vision Systems. Knowledge and experience with sterile and non-sterile packaging material process and testing. Experience with AGILE Supervisory Responsibility This position has no direct supervisory responsibilities. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand, walk, and sit for extended periods of time; reach for tools and objects with hands and arms; climb stairs; stoop, kneel, crouch, or crawl; and talk and hear. The employee must occasionally lift up to 25 pounds. The employee must be able to see up close and at a distance, as well as use peripheral vision and depth perception, and be able to look at, read, and use a computer for long periods of time. Position Type and Expected Hours of Work This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m. Occasional evening and weekend work may be required as job duties demand. Travel Approximately 10% Education and Experience 1. At least five (5) years of previous experience in a regulated business environment 2. Bachelor---s Degree in Packaging Engineering (or related sciences) AAP/EEO Statement Accelus is proud to be an equal opportunity and affirmative action employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Keywords: Accelus, Denver , Principle Packaging Engineer, Engineering , Louisville, Colorado