Senior Packaging Engineer

Company: Careerbuilder US
Location: Irvine
Posted on: January 12, 2021

Job Description:

ATR International, Inc. is a leader in the staffing industry and places a wide range of professionals at many of the most innovative companies. We are currently recruiting for the following position for one of our clients. If this position is not a fit for you, click here to send us your resume and our recruiters will find one that is. Position Information: Requisition Number: ATR178084 Position title: Senior Packaging Engineer Location: Irvine, CA Contact Information: Lecrecia Prince: lecreciapatr1.com Job Description: OB SUMMARY: Works with various disciplines of the engineering team, operations, quality, regulatory, and business development to drive and manage multiple projects supporting the needs for sustaining packaging engineering as well as new product development. Areas of focus will be the technical lead for design, development, and validation of new medical device packaging and labeling solutions as well as improvements to existing packaging solutions. The position plays a key role working with multiple project teams to ensure compliance, sustain product life cycle, and transfer new product development to production. JOB DUTIES: -- Apply knowledge of packaging materials, manufacturing methodologies, and the distribution environment hazards to develop sterile barrier packaging, and protective packaging solutions that meet medical device design requirements for ISO11607-1 & 2. -- Responsible for the development of test protocols, validation plans, package testing, validations and the final reports that ensure our package systems meet the needs of our internal and external customers while maintaining regulatory compliance. -- Responsible for audit support for all documents (protocols and reports), testing and validation, procedures, and training for the developed package systems. -- Will partner with the supply chain team in developing and evaluating supplier capabilities, processes, troubleshooting, materials, cost, and delivery options. -- Responsible for all packaging process development activities to meet the needs of the project teams and supply chain including but is not limited to: Prototype delivery/evaluation, CAD needs, BOMs, routings, transit or other lab evaluation testing, packaging material and process specifications/standards, First Article Inspections on new or modified packaging components, process development, qualification and validation, and packaging component or process troubleshooting. -- Evaluate and optimize packaging processes for cost effectiveness, scrap rate and lean production including the use of statistical tools. -- Manage the development, procurement and installation of packaging fixtures, tooling, and capital equipment necessary for the implementation of new or incremental packaging processes to support the needs of the business. -- Performs other duties as assigned. The ideal candidate will possess the following qualifications: SKILLS AND QUALIFICATIONS: -- A Bachelor's Degree in an Engineering field and a minimum of five (5) years work-related experience in Packaging engineering is required. -- A minimum of three (3) years--- experience in a Medical Packaging environment. -- Desire to work in a result based, fast paced environment by working independently as well as be a team player. -- Ability to handle increasingly complex project requirements with minimal supervision. -- Strong project management and multi-tasking skills are required due to multiple priorities and projects being handled at any one time. -- Strong interpersonal skills with the ability to build trust and influence cross functional partners. -- Medical device background and working knowledge of IEC 60601-x is preferred. -- Experience with design controls for medical devices Title 21 CFR 820 and ISO 13485 is preferred. -- Experience with Risk Management ISO 14971 is preferred. -- Experience with distribution simulation testing per ASTM and ISTA standards is preferred. -- Experience with packaging and transport of rechargeable and single-use batteries is preferred. -- Experienced with Project Management tools including Microsoft Project to create project schedules, determine critical path, and account for all activities to complete a task/deliverable. -- Knowledgeable in the design, development and engineering of new packaging and labeling, changes to existing packaging and labeling, and recommendation of packaging and labeling equipment. -- Demonstrated use of quality tools (Statistics, Lean, Six Sigma, DOE, Risk Analysis, etc.). -- Ability to analyze and interpret engineering drawing specifications and perform tolerance stacks per ANSI Y14.5 and established drafting standards is preferred. -- Extensive knowledge in materials and manufacturing processes as well as a good working knowledge of sterilization methods and their effects on packaging components is required. -- Have an understanding of medical device product/process validations, production requirements, quality and audit requirements, and project management. ACCOUNTABILITY: -- Assume responsibility and ownership of assigned tasks with minimal direction and guidance. -- Exercise initiative and judgement with data driven decision making. -- Provide support to team members, customers, and others in the company as required. -- Assure all regulations, policies, procedures, or processes are followed as specified by the company. -- Utilize standards and best practices where appropriate. -- Maintain a safe working environment. -- Hands on approach to problem solving. -- Expected from time to time to put in extra time and effort to complete critical tasks to meet deadlines or objectives for the company. INTERPERSONAL AND COMMUNICATIONS SKILLS: -- Team Environment: Must be able to work in a fast paced team environment and collaborate in a positive and professional manner. This may include taking on tasks and responsibilities overlapping with other team members. -- Conflict: Must be able to negotiate and resolve issues with team members and management in a positive and professional manner. -- Communication: Must be a strong communicator able to convey clear and concise information to team members, management, or customers. Good listening skills are required. -- Ownership: Must be able to take ownership of problems, issues, or challenges with minimal guidance to troubleshoot and work through them. Is this position not a fit for you? Click here to send us your resume and our recruiters will find one that is. To be considered for this position, please click the "Apply Now" button. Visit our website at www.atrinternational.com for an up-to-date listing of opportunities. Job Requirements: Translate new packaging designs into documented packaging specifications Maintain packaging data in the packaging systems Support new product development packaging initiatives and packaging design reviews Create packaging related protocols and conduct packaging studies Lead new packaging development projects Improve packaging entering the facility to ensure packaging standards Validate package components and packaging processes Resolve packaging issues associated with packaging component quality, packaging equipment, and packaging line efficiency, participate in deviation resolutions as a result of packaging component quality Troubleshooting and resolving packaging issues associated with packaging component quality, packaging equipment, and packaging line efficiency Support supplier quality engineering and managing packaging process validations with external packaging and packaging component suppliers Manage and develop packaging specifications Provide direction to packaging suppliers on new and revised packaging specifications Approve packaging materials and components Develop packaging standards and specifications Develop internal packaging/dunnage specifications Support all packaging testing activities Resolve issues on packaging floor related to packaging Coordinate and perform packaging line trials Using company approved packaging suppliers Analyze effectiveness of the packaging system, development of packaging standards and improvements to existing packaging

Keywords: Careerbuilder US, Irvine , Senior Packaging Engineer, Other , Irvine, California