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KH

Product Industrialization Engineer

Katalyst Healthcares & Life Sciences
  • ๐Ÿ‡บ๐Ÿ‡ธ United States
  • On-site
  • Staff / Principal
  • 9 hours ago
  • Configuration Management
  • Risk Management
  • Windchill
  • Change Management
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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.

Product Industrialization Engineer ยท Katalyst Healthcares & Life Sciences

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