| Job Description: |
Role Descriptions: · 7+ years of engineering experience in medical device or other regulated industries. · Experience leading cross-functional technical projects. · Experience with component development, supplier qualification, design verification, and manufacturing validation. · Strong understanding of design controls, change management, risk management, process validation, and quality system compliance.
Must Have Technical/Functional Skills
· Strong expertise in Medical Device Product Lifecycle Management (PLM), Design Controls, and Engineering Change
Management (ECO/ECN/ECR).
· Hands-on experience with Design Verification & Validation (V&V), test methods, protocol development, and technical
documentation.
· Deep understanding of Risk Management methodologies, including ISO 14971, DFMEA, PFMEA, and hazard analysis.
· Knowledge of Quality Management Systems (QMS), ISO 13485, FDA 21 CFR Part 820/QMSR, and regulatory
compliance requirements.
· Experience in Supplier Quality Engineering, component qualification, supplier development, and Design for Manufacturability (DFM). · Proficiency in Process Validation activities including IQ/OQ/PQ, pilot builds, validation builds, and manufacturing transfer. · Ability to interpret engineering drawings, GD&T, tolerance stack-ups, specifications, and acceptance criteria. · Strong root cause analysis and problem-solving skills utilizing 8D, CAPA, 5 Why, Fishbone, and corrective action processes. · Excellent project management skills, including planning, scheduling, risk management, stakeholder management, and cross-functional coordination. · Effective leadership, communication, and influencing skills, with the ability to drive decisions and deliver results without direct authority.
Roles & 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.
Generic Managerial Skills, If any
· Strong communication skills, with proficiency in reading, writing, and speaking English.
· Ability to multitask, understand customer requirements, and respond promptly and accurately.
· Capability to prioritize and manage multiple tasks in a fast‑paced environment.
· Ability to understand and follow complex written procedures.
· Ability to work effectively in a team environment and contribute to team goals.
· Strong decision‑making and problem‑solving abilities with sound situational judgment.
Essential Skills: EIS : MDD Risk Management
Desirable Skills:
Keyword:
Skills: EIS : New Product Development (NPD) Methodology and Management~EIS : MDD Risk Management
Experience Required: 6-8
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