- 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.
- 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.
Job Description
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.
- 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.
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.
Salary Range
Salary Range: $70,000 -$80,000 year
TCS Employee Benefits Summary- Discretionary Annual Incentive.
- Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
- Family Support: Maternal & Parental Leaves.
- Insurance Options: Auto & Home Insurance, Identity Theft Protection.
- Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
- Time Off: Vacation, Time Off, Sick Leave & Holidays.
- Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
Qualifications
BACHELOR OF COMPUTER SCIENCE
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