Role Overview:The Senior New Product Development Engineer will be responsible for leading multiple high-priority lifecycle change projects from their initial concept through successful implementation. This role involves driving comprehensive project plans, establishing timelines, developing robust risk mitigation strategies, and ensuring overall implementation readiness. The engineer will coordinate diverse cross-functional teams across various departments including Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, and Operations, as well as managing external suppliers. A key aspect of this position is serving as the technical interface with suppliers for critical activities such as component development, Design for Manufacturability (DFM) reviews, tooling readiness, process capability assessments, and component qualification.
Key Responsibilities:- Lead multiple high-priority lifecycle change projects from concept through implementation.
- Drive project plans, timelines, risk mitigation strategies, and implementation readiness.
- Coordinate cross-functional teams across Engineering, Quality, Regulatory, Manufacturing, Supply Chain, Procurement, Operations, and external suppliers.
- Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability, and component qualification.
- Support design verification and validation activities, including test planning, execution, data review, and technical documentation.
- Partner with manufacturing sites on process validation activities, including IQ/OQ/PQ, pilot builds, validation builds, and production launch readiness.
- Apply strong knowledge of design controls, engineering change management, risk management, quality system requirements, and regulatory expectations.
- Review engineering drawings, specifications, GD&T requirements, tolerance analyses, and component acceptance criteria.
- Drive root cause analysis, technical problem solving, and timely closure of project issues.
- Communicate project status, risks, decisions, and recommendations clearly to stakeholders and senior leadership.
- Demonstrate strong ownership, urgency, accountability, and ability to influence without direct authority.
Required Skills:- Senior-level engineering expertise.
- New Product Development (NPD) Methodology and Management.
- MDD Risk Management.
- Strong knowledge of design controls, engineering change management, and quality system requirements.
- Experience with regulatory expectations and risk management.
- Proficiency in reviewing engineering drawings, specifications, GD&T requirements, and tolerance analyses.
- Ability to drive root cause analysis and technical problem solving.
Qualifications:- 6-8 years of relevant experience.
