Job Description:

• In this role, you will be responsible for planning, organizing, and leading projects to support the development of new packaging systems and or components that enhance and preserve high value products.
• The ideal candidate will drive technical projects, work with cross-functional development teams, and work with strategic suppliers to develop new packaging systems. You will act as a subject matter expert for system and component packaging and drive technical decisions which support business objectives.
• Key responsibilities include project management, testing coordination and execution, specification / drawing development, Design History File (DHF) documentation creation and cross functional collaboration while engaging with various project teams and functional groups.
• As a Senior Engineer, you will be responsible for mentoring more junior engineers within the group and identifying innovative solutions to broaden portfolio. The incumbent will.
• Demonstrate accountability for the successful and timely achievement of goals.
• Work independently only with strategic guidance in the most complex situations.
• Interpret internal and external business issues and unmet needs and take a broad perspective to define/plan/lead/develop solutions.

Responsibilities:

• Technical packaging lead for Integrated Systems R&D efforts related to product design and development processes from conceptualization to commercialization.
• Engage with cross-functional teams that include R&D, Pharma Processing, Marketing, Regulatory, Quality and Supply Chain to develop new packaging solutions.
• Develop innovative packaging solutions to support business growth.
• Design the packaging solutions based on various packaging and shipping standards.
• Create, Design, and execute simulation tests for the new packing and shipping solutions.
• Responsible for creation and maintenance of packaging elements for Design History File (DHF) for all assigned projects including Design Inputs, Risk Analysis (FMEAs), test protocols, and Design Verification.
• Support customers and suppliers as required for the development of new packaging solutions. Maintain effective communications and working relations with all external parties.
• Coordinate packaging testing activities for engineering studies and protocols through internal and contract packaging laboratories.
• Deliver technical reports, executive summaries, and presentations to communicate activities and timelines to management and core team members.
• Identify and drive continuous improvement efforts within the packaging group.
• Other duties as assigned.
• Maintain effective communications and working relations with all external parties.

Requirements:

• Bachelors in Packaging, Mechanical, Materials, or Chemical Engineering, or related engineering discipline.
• Master’s degree preferred.
• Experience: 5-8 years of experience in development of packaging, medical devices, or combination products.
• Previous experience in packaging development of sterile barrier systems.
• Experience leading technical projects from concept through commercialization.
• Experience in working under requirements of Quality Management System in a regulated environment.
• Experience in communicating complex technical concepts to customers and internal stakeholders.
• Thorough understanding of global testing standards and regulatory requirements related to sterile barrier packaging.
• Excellent interpersonal and written/verbal communication skills.
• Working understanding and application of fundamental engineering principals.
• Strong technical writing abilities.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Able to always comply with the company’s safety policy and quality.

• Technical packaging lead for Integrated Systems R&D efforts related to product design and development processes from conceptualization to commercialization.
• Engage with cross-functional teams that include R&D, Pharma Processing, Marketing, Regulatory, Quality and Supply Chain to develop new packaging solutions.
• Develop innovative packaging solutions to support business growth.
• Design the packaging solutions based on various packaging and shipping standards.
• Create, Design, and execute simulation tests for the new packing and shipping solutions.
• Responsible for creation and maintenance of packaging elements for Design History File (DHF) for all assigned projects including Design Inputs, Risk Analysis (FMEAs), test protocols, and Design Verification.
• Support customers and suppliers as required for the development of new packaging solutions. Maintain effective communications and working relations with all external parties.
• Coordinate packaging testing activities for engineering studies and protocols through internal and contract packaging laboratories.
• Deliver technical reports, executive summaries, and presentations to communicate activities and timelines to management and core team members.
• Identify and drive continuous improvement efforts within the packaging group.
• Other duties as assigned.
• Maintain effective communications and working relations with all external parties