R&D Product Development Packaging Engineer

Job Description

The R&D Packaging Engineer III will impact health care and the MDS business groups by driving commercialization of new products and design changes for current products through development, qualification and launch phases. The R&D Packaging Engineer III is energetic and excited to bring innovation to commercialization. He or she will use their deep technical expertise to develop novel medical devices, including concept development, device verification and validation, and root cause analysis. As challenges arise, she or he will not only carry out experiments to resolve it, but also recommend the path forward.

Job Responsibilities

• Lead R&D deliverables throughout the medical device design control process for intravenous infusion sets and connection devices
• Collaborate within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices
• Engineer robust products through strong understanding and application of engineering fundamentals and DFSS principles and/or Six Sigma tools (Kaizen, process improvement)
• Develop technical plans and guide the team to develop design inputs, conduct analytical and empirical feasibility studies, refine product configurations and designs, verify and validate subsystems and systems, concurrently transfer designs alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies
• Execute design verification testing to confirm design outputs meet design input requirements

Required Qualifications

• BS - Mechanical Engineering, Materials Engineering or Biomedical Engineering
• Work experience 5 years or 3 years plus an advanced degree on development of ISO 11607, ASTM Packaging Standards and Medical Device Packaging Design
• SolidWorks or equivalent CAD tool
• Critical thinking - able to work with moderate guidance in own area of knowledge
• Able to manage multiple projects of varying scopes in parallel
• Able to work leading or as part of a cross-functional team with members from marketing, sales, clinical, regulatory, medical affairs, quality, manufacturing, etc.
• Experience with medical device design control processes and creating and maintaining design control documentation