Senior Product Industrialization Engineer – Medical Devices | Contract | Orlando, FL (Onsite)
Senior Product Industrialization Engineer – Medical Devices
Location: Orlando, FL (Onsite)
Job Type: Contract
Experience: 8+ Years
Job Summary
We are seeking an experienced Senior Product Industrialization Engineer to lead onsite engineering activities and serve as the primary technical interface between customer stakeholders and globally distributed engineering teams.
The ideal candidate will have strong experience in sustaining engineering, product industrialization, manufacturing support, product lifecycle management, and engineering change management within medical-device or other regulated manufacturing environments.
This role requires a technically strong engineering professional with leadership capabilities, customer-facing communication skills, and the ability to drive engineering execution across onsite and offshore teams.
Key Responsibilities
Lead onsite engineering activities related to product industrialization, sustaining engineering, and product lifecycle management.
Coordinate engineering activities across customer stakeholders, suppliers, manufacturing teams, and offshore engineering teams.
Drive engineering change management activities, including ECO, ECN, ECR, and product configuration changes.
Support product releases, engineering documentation, specifications, and configuration management.
Update and maintain product specifications, technical documentation, and product labeling.
Plan, coordinate, and document engineering and design reviews.
Track engineering review actions, project deliverables, risks, and issue-resolution activities.
Manage First Article Inspection (FAI) activities and ensure timely completion and documentation.
Support manufacturing engineering, product transfers, NPI, and sustaining engineering initiatives.
Collaborate with Quality, Regulatory, Manufacturing, and Engineering teams to address technical and compliance-related issues.
Provide technical leadership and execution guidance to globally distributed engineering teams.
Ensure engineering deliverables comply with applicable quality standards and regulatory requirements.
Required Qualifications
Bachelor's or Master's degree in Mechanical, Biomedical, Manufacturing, Industrial, Electronics Engineering, or a related technical discipline.
8+ years of relevant experience in Product Industrialization, Sustaining Engineering, Product Engineering, Manufacturing Engineering, or related engineering functions.
Experience working in medical devices, healthcare, life sciences, or other regulated manufacturing industries.
Strong understanding of product lifecycle management and sustaining engineering activities.
Hands-on experience with engineering change management, including ECO, ECN, ECR, and change control processes.
Experience supporting manufacturing operations, product releases, and engineering documentation.
Ability to update technical specifications, prepare product labels, and maintain controlled engineering documentation.
Experience planning and documenting design reviews and tracking action items through completion.
Experience managing First Article Inspection (FAI) activities and associated documentation.
Strong customer-facing communication, stakeholder management, and cross-functional coordination skills.
Experience coordinating onsite and offshore engineering teams.
Ability to work independently and drive technical execution with minimal supervision.
Preferred Qualifications
Experience with PLM platforms such as PTC Windchill, Siemens Teamcenter, Agile PLM, or equivalent systems.
Experience supporting New Product Introduction (NPI), product transfers, and sustaining engineering programs.
Knowledge of FDA-regulated manufacturing, ISO 13485, and applicable quality management systems.
Exposure to CAPA, nonconformance management, engineering risk management, and quality processes.
Experience working with global engineering teams and external suppliers.
Key Skills
Product Industrialization
Sustaining Engineering
Product Lifecycle Management (PLM)
Engineering Change Management (ECO/ECN/ECR)
Manufacturing Engineering
New Product Introduction (NPI)
PTC Windchill / Teamcenter
First Article Inspection (FAI)
Design Reviews & Technical Documentation
Medical Device Quality Systems
Customer & Stakeholder Management
Offshore Engineering Coordination
Ideal Candidate Profile
The ideal candidate is a senior engineering professional with a strong background in medical-device product engineering, industrialization, and sustaining engineering.
Candidates with previous experience at established healthcare and medical-device organizations, including Philips or similar companies, are highly desirable.
The successful candidate should be capable of leading onsite engineering execution, managing customer expectations, coordinating global engineering teams, and driving product-related technical activities to completion.
Work Location: Orlando, Florida – Onsite
