Packaging Engineer I #2001

About ECI

ECI's mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the role

As Packaging Engineer, you will support packaging engineering design, development and validation efforts on ECI's client centric projects. You will work with the client to apply your knowledge and packaging engineering principles to lead and execute efforts involving packaging design. In this role you will collaborate in fast-paced cross-functional teams environment to maintain and packaging engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements.

What you'll do

• Lead Packaging Core Teams consisting of representation from packaging, distribution, operations, test methods, labeling, and graphics
• Provide Packaging Engineering support for R&D projects related to medical devices/capital equipment.
• Generate and manage the generation of packaging related documentation including specifications, test plans and reports, and other Product Development Process documents
• Manage the completion of packaging testing for new product development and existing design improvements
• Work closely with other members of the client packaging teams, and interact with personnel from a variety of areas within the client company
• Developing strong team skills, including optimized communication, teamwork, initiative, and managed execution of project deliverables
• Work with client's suppliers to establish partnerships to maximize quality, delivery, and lead times, and to incorporate their abilities, ideas, and material knowledge into new development
• Keep abreast of new technologies and advances in the medical device packaging industry
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements
• Develop, review and approve quality documentation such as packaging validation, quality plans, standard operating procedures, and inspection procedures. Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities
• Fabrication/evaluation of materials, components, devices, test fixtures and prototypes
• Lead effectively within a technical and project team environment conducting meetings and presentations
• Identify industry best practices. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices
• Ensure that packaging changes to existing products and manufacturing lines are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards

What you will bring

• Bachelor's degree in Mechanical, Industrial or Packaging Engineering
• Minimum of 1+ years of experience in design, development and validation of packaging in a FDA regulated industry (medical devices preferred); or equivalent combination of education and/or experience is required
• Experience in bringing creative package designs from concept through commercialization
• Familiarity with the medical device industry, FDA regulations, ISO 11607, quality systems, and sterilization preferred
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form
• Ability to handle multiple projects and effectively manage timelines
• Demonstrated interpersonal skills with the ability to work within a team environment
• Demonstrated strong engineering, design, and analysis skills
• Proficient use in current versions of MS Excel, MS Project, MS Word, and familiarity with product data management software preferred

Working Conditions and Physical Effort

• Position may include exposure to loud noises from machines and or alarms.
• Position may require from time to time, physical work; heavy lifting, pushing, or pulling required of objects up to 20-25 pounds.
• Work environment may involve some exposure to hazards or physical risks, which will require following basic safety precautions.
• Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, and/or unpleasant odors
• All required personal protective equipment (PPE) will be provided to ensure a safe working environment.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.