Lead Product Industrialization Engineer

Mantu; Orlando (FL); On-site; USD 110,000 - 160,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

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

Education

Bachelor's degree in Engineering

Tools

Windchill PLM

CodeSoft

SAP QM

Job description

Work model: Onsite, approximately 3 to 4 days per week

About the opportunity

Amaris Consulting is looking for a Lead Product Industrialization Engineer to support a medical-device patient-monitoring product line as it transitions from R&D into manufacturing, both internally and through external suppliers.

This is a high-ownership role combining hands‑on engineering, industrialization coordination, documentation control, supplier support, and team leadership. You will act as the primary point of contact between the client and a 4 to 5‑person offshore delivery team, ensuring clear priorities, predictable execution, high-quality documentation, and on‑time delivery.

Key responsibilities

• Serve as the day-to‑day client contact for the product industrialization engagement.
• Translate client priorities into clear assignments, deliverables, and deadlines for the offshore engineering team.
• Coordinate task ownership, prioritization, workload, turnover, and delivery follow‑up.
• Lead and review drawing updates, specification changes, and technical investigations through Windchill PLM.
• Capture design‑review comments and prepare Engineering Design Review Records (EDRR).
• Coordinate First Article Inspection plans and reports, receiving inspection forms, test reports, and release documentation.
• Support engineering changes, including ECO/ECR, Engineering Change, CCB, SICR, and Quality Notification activities.
• Support MLD and NPI projects, Assurance‑of‑Supply activities, and sustaining‑engineering initiatives.
• Coordinate obsolescence management, legacy‑component redesign, drawing updates, and portfolio‑refresh activities.
• Review and structure supplier‑quality documentation, including APQP, PPAP, CoC, CoA, material certifications, and receiving records.
• Support process validation and qualification reporting, including documentation review and posting to EDMS/DMS platforms.
• Coordinate country‑specific product‑label files in CodeSoft for manufacturing and warehouse printing.
• Work with Regulatory and R&D teams on label specifications and labeling‑standard updates.
• Support BOM structuring, supplier outreach, and approval tracking.
• Lead knowledge transfer from the incumbent team and ensure continuity during the transition.
• Maintain a proactive delivery approach, anticipate issues, and ensure work progresses without repeated follow‑up from the client.

Required qualifications

• Bachelor’s degree in Mechanical, Electrical, Industrial, Biomedical Engineering, or a related discipline. Equivalent experience may be considered.
• At least 5 years of experience in Product Industrialization, Manufacturing Engineering, NPI, or Sustaining Engineering.
• Experience in a regulated environment, preferably medical devices or another regulated hardware industry.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, or comparable quality‑system requirements.
• Hands‑on experience with Windchill PLM and engineering document control.
• Strong knowledge of:
• Engineering drawings and specifications
• Design‑review workflows
• ECO/ECR and change control
• First Article Inspection
• Incoming and receiving inspection
• CoC/CoA and material certifications
• BOM structuring
• Release documentation
• Working knowledge of APQP, PPAP, and supplier‑quality processes.
• Experience leading a distributed or offshore engineering team as the primary point of contact.
• Strong written and verbal English communication skills.
• Authorized to work in the United States.
• Ability to work onsite in Orlando approximately 3 to 4 days per week.
• Ability to use a client‑issued laptop for Windchill access.

Preferred qualifications

• Experience with CodeSoft, CDLM, or medical‑device labeling systems.
• Knowledge of SAP QM, quality notifications, or supplier‑quality workflows.
• Experience with EMC or RED testing documentation.
• Knowledge of medical‑device EMC standards.
• Experience with EDMS or DMS platforms.
• Experience with obsolescence management and sustaining engineering.
• Practical use of AI tools for technical‑procedure and document searches.
• Experience coordinating high‑volume document reviews and engineering updates under tight deadlines.

Why join this engagement?

This is an opportunity to take a central leadership role in a long‑term medical‑device industrialization program. You will work directly with client stakeholders, lead a distributed engineering team, and contribute to the transition of products from development into manufacturing and sustaining operations.