Lead Product Industrialization Engineer
- |5 years of exp
- |Full Time
In office - WFH flexibility
Not Available
About the job
Lead Product Industrialization Engineer
Location: Orlando, FL
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.
