Product Industrialization Engineer

Katalyst CRO; Orlando (FL); On-site; USD 100,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking an experienced Product Industrialization Engineer to lead onsite engineering activities and act as the primary interface between customer stakeholders and global engineering teams.

The ideal candidate has strong experience in sustaining engineering, product lifecycle management, and manufacturing support within regulated industries. This hands-on leadership role requires technical depth, ownership, and effective stakeholder management.

Qualifications

• Bachelor's or master's in engineering or related field required.
• Experience in medical devices or other regulated industries.
• Strong focus on technical, regulatory, quality, and improvements.

Responsibilities

• Lead onsite execution for sustaining engineering and product industrialization programs.
• Coordinate activities across customer stakeholders, suppliers, manufacturing, and offshore teams.
• Drive engineering changes and product lifecycle activities.
• Support product releases, technical documentation, and configuration management.
• Participate in engineering reviews and cross-functional discussions.
• Support quality and compliance-related activities.
• Coordinate issue resolution, risk management and execution tracking.
• Provide technical leadership to distributed engineering teams.

Skills

Stakeholder management

Regulated industries experience

Cross-functional leadership

Independent execution

Technical leadership

Education

Bachelor's or Master's in Mechanical, Biomedical, Manufacturing, Industrial or Electronics Engineering

Job description

About The Role

We are looking for an experienced Product Industrialization Engineer to lead onsite engineering activities and act as the primary interface between customer stakeholders and global engineering teams.

About The Role

We are looking for an experienced Product Industrialization Engineer to lead onsite engineering activities and act as the primary interface between customer stakeholders and global engineering teams. The ideal candidate will bring strong experience in sustaining engineering, product lifecycle management, manufacturing support, engineering changes, quality processes, and cross-functional coordination within regulated industries. This is a hands-on leadership role requiring technical depth, ownership, and effective stakeholder management.

Key Responsibilities

• Lead onsite execution for sustaining engineering and product industrialization programs.
• Coordinate activities across customer stakeholders, suppliers, manufacturing teams, and offshore engineering teams.
• Drive engineering change implementation and product lifecycle activities.
• Support product releases, technical documentation, and configuration management.
• Participate in engineering reviews and cross-functional discussions.
• Support quality and compliance-related engineering activities.
• Coordinate issue resolution, risk management, and execution tracking.
• Provide technical leadership and direction to distributed engineering teams.

Required Qualifications

• Bachelor's or master's degree in mechanical, Biomedical, Manufacturing, Industrial, Electronics Engineering, or a related field.
• 8+ years of relevant experience in Product Industrialization, Sustaining Engineering, Manufacturing Engineering, Product Engineering, or a related discipline.
• Experience in medical devices, healthcare, life sciences, or another regulated industry.
• Must focus on the technical, regulatory, quality, investigative and improvements of the products.
• Strong experience with engineering changes and product lifecycle activities.
• Customer-facing communication and stakeholder management experience.
• Experience coordinating globally distributed engineering teams.
• Ability to work independently and drive execution with minimal supervision.
• Ability and willingness to work onsite in Orlando, Florida.
• Ability to update Specifications, Create labels,
• Plan and Document Design reviews, Action Tracking.
• Manage first article inspections and completions.

Preferred Qualifications

• Experience with PLM systems such as Windchill or an equivalent platform.
• Experience supporting NPI and sustaining engineering initiatives.
• Experience with quality systems and controlled engineering documentation.
• Exposure to supplier coordination and manufacturing support.
• Experience in FDA, ISO 13485, or similarly regulated environments.

Key Competencies

• Product Industrialization
• Sustaining Engineering
• Engineering Change Management
• Product Lifecycle Management
• Manufacturing Engineering
• Cross-Functional Leadership
• Stakeholder Management
• Technical Documentation
• Program Execution

Ideal Candidate

An ex-Philips, senior - engineering professional with strong leadership skills, customer-facing experience, and the ability to drive execution across onsite and offshore teams in a regulated product environment.