NPD Engineer

Technical/Functional Skills

• Ability to quickly build connections with internal and external partners
• Ability to manage multiple projects and tasks simultaneously
• Ability to read engineering drawings, GD&T, terminology, schematics
• Knowledge and experience in product development processes and design control is preferred.
• In-depth knowledge of design of medical devices preferred.
• Ability to be a technical leader on multi-functional teams
• Excellent verbal and written communication skills, including but not limited to, the ability to relate technical requirements, listen effectively, influence decision-makers by data and be able to receive constructive input from others.
• Ability to solve complex problems

Experience Required

5-6 Years

Roles & Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:

• - Must be able to perform characterization studies with statistical analysis and create test reports
• - Must write process instructions, manufacturing operating procedures, and PFMEAs
• - Must build equipment and setup manufacturing line(s)
• - Process and run engineering WOs
• - Able to travel within USA and Mexico if required to write and execute IQ/OQ/PQ
• - Must be able to write and stage ECOs
• Responsible for the successful planning, coordination, execution, implementation, and timely completion of project deliverables ensuring consistency with company policies, procedures, and commitments
• Lead and drive execution of design for manufacturing including component manufacturing within the principles of DMAIC
• Ensure on-schedule and on-cost delivery of projects while managing project activities during all phases such as Engineering, Documentation, Process, Operations, Planning, etc.
• Communicate with all project stakeholders, core team, extended team, and cross-functional members
• Develop innovative workflows to generate compelling technical evidence of product or project performance under challenging conditions
• Prepare and present technical information in a clear and effective manner to project leads, managers, stakeholders
• Review and coordinate drawings, BOMs, specifications, protocols, test reports, plans, etc.
• Actively coordinate and mitigate delays within project and tasks
• Collaborate with cross-functional team, work with engineering, manufacturing, marketing and suppliers
• Ensure continued compliance of project and/or portfolio to applicable standards and regulations
• Create, track, and maintain all project documentation and progress such as Design History File, Design History Records, Engineering Change Orders, Technical File, etc.
• Follow strict adherence to policies and procedures associated with FDA and any other Notified Body (EU-MDR, PMDA, NMPA, ANVISA, etc) controlled environment