Katalyst Healthcares and Life Sciences
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.
- 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.
- 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.