Senior Medical Device Industrialization Leader

Mantu; Orlando (FL); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Amaris Consulting seeks a Lead Product Industrialization Engineer to support a medical-device line as it moves from R&D to manufacturing. You will lead a 4–5 person offshore team, own delivery priorities, and ensure high-quality documentation and on-time results.

Requires 5+ years in industrialization, Windchill PLM expertise, and strong regulatory knowledge. Onsite in Orlando 3–4 days/week with client collaboration and cross-functional leadership.

Formación

• Bachelor’s degree in Mechanical, Electrical, Industrial, Biomedical Engineering, or related discipline.
• 5+ years in Product Industrialization or Manufacturing Engineering.
• Experience in a regulated environment (medical devices preferred).
• Familiarity with FDA 21 CFR Part 820, ISO 13485 or similar standards.
• Hands-on Windchill PLM and document control experience.
• Strong knowledge of engineering drawings, ECO/ECR, and change control.

Responsabilidades

• Serve as day-to-day client contact for the product industrialization engagement.
• Translate client priorities into assignments and deadlines for offshore team.
• Coordinate task ownership, workload, and delivery follow-up.
• Lead and review drawing updates and technical investigations in Windchill PLM.
• Capture design-review comments and prepare EDRR.
• Coordinate First Article Inspection plans and reports and related documentation.
• Support ECO/ECR, CCB, SICR, and Quality Notification activities.
• Support MLD, NPI, Assurance-of-Supply, and sustaining engineering.
• Coordinate obsolescence management and portfolio-refresh activities.
• Review supplier-quality docs: APQP, PPAP, CoC/CoA, and certifications.
• Support process validation and EDMS/DMS posting.
• Coordinate country-specific label files in CodeSoft for manufacturing.
• Work with Regulatory and R&D on labeling standards.
• Support BOM structuring and supplier outreach.
• Lead knowledge transfer to ensure continuity.
• Maintain proactive delivery and minimize client follow-ups.

Conocimientos

Windchill PLM

Offshore team leadership

English communication

Regulatory environment knowledge

BOM structuring

ECO/ECR & change control

First Article Inspection

APQP/PPAP

Supplier-quality processes

Documentation control

Educación

Bachelor's degree in Engineering

Herramientas

Windchill PLM

CodeSoft

SAP QM

Descripción del empleo

Amaris Consulting seeks a Lead Product Industrialization Engineer to support a medical-device line as it moves from R&D to manufacturing. You will lead a 4–5 person offshore team, own delivery priorities, and ensure high-quality documentation and on-time results.

Requires 5+ years in industrialization, Windchill PLM expertise, and strong regulatory knowledge. Onsite in Orlando 3–4 days/week with client collaboration and cross-functional leadership.