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Design History Jobs in Indiana (NOW HIRING)

Prophecy Technologies

Quality Engineer

Indianapolis, IN · On-site

$68K - $88K/yr

* Support Design History File (DHF) activities for medical device development projects. * Review, update, and maintain Global dFMEA documentation ensuring risks are adequately identified, analyzed, and ...

Vera Bradley

Associate Surface Designer

Roanoke, IN · On-site

Maintain strong knowledge of current surface design trends and historical surface design history through constant research and self-education. * Assist with the organization and distribution of ...

Red Star

Senior Sterile Packaging Engineer

IN · On-site

This position provides technical leadership for packaging design and development, validation strategy, process controls, and technical documentation, including Design History File (DHF) requirements.

Simon Property Group

Manager, Design

Indianapolis, IN · On-site

$110 - $170/hr

Design Leadership: Manage external AE consultants through the design process from concept through ... history of successful retail real estate development, management, and leasing. Simon was named ...

New

Zimmer, Inc.

Development Sr Engineer I

Warsaw, IN

... design history files Writing and executing technical protocols and reports for both process validations and design verification/validations requirements Active participation in development meetings ...

Red Star

Senior Sterile Packaging Engineer

Larwill, IN · On-site

This position provides technical leadership for packaging design and development, validation strategy, process controls, and technical documentation, including Design History File (DHF) requirements.

Red Star

Sterile Packaging Manager

Larwill, IN · On-site

The Sterile Packaging Manager provides leadership for packaging design and development, validation strategy, process controls, and technical documentation, including Design History File (DHF ...

Red Star

Sterile Packaging Manager

IN · On-site

The Sterile Packaging Manager provides leadership for packaging design and development, validation strategy, process controls, and technical documentation, including Design History File (DHF ...

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Design History information

What is the difference between Design History vs Design Documentation?

AspectDesign HistoryDesign Documentation
PurposeTracks the evolution and decisions of a design project over timeProvides detailed records of design specifications, drawings, and instructions
FocusProcess, revisions, and rationale behind design changesFinalized details, technical data, and implementation guidelines
Work EnvironmentDesign teams, project management, product developmentEngineering, manufacturing, quality assurance
Common UsageUsed to document design evolution for future reference or auditsUsed for manufacturing, compliance, and technical reference

Design History focuses on recording the development process and decision-making behind a design, while Design Documentation provides detailed technical records necessary for manufacturing and compliance. Both are essential but serve different stages of the product lifecycle.

What are some common challenges faced by professionals working in design history roles within organizations?

Professionals in Design History roles often face the challenge of balancing historical research with practical application, ensuring that archival information is both accurate and accessible for current design projects. They may also need to collaborate closely with designers, archivists, and curators to contextualize historical artifacts and trends in a way that informs and inspires contemporary work. Navigating incomplete records and rapidly evolving design technologies can require creative problem-solving and adaptability. Additionally, communicating the relevance of historical insights to stakeholders who may be more focused on present-day innovation is a key aspect of the role.

What is design history?

Design history is the study of the evolution, context, and impact of design across different periods and cultures. It explores how design practices, styles, movements, and technologies have developed over time and influenced society. Design historians analyze objects, graphics, architecture, fashion, and other creative works to understand their cultural significance and how they reflect broader historical trends. This field helps inform contemporary design by providing insights into past innovations and societal needs.

What are the key skills and qualifications needed to thrive as a design historian, and why are they important?

To thrive as a Design Historian, you need a strong background in art and design history, research methods, and academic writing, usually supported by an advanced degree in a related field. Familiarity with digital archives, citation management software, and academic databases is commonly required. Analytical thinking, attention to detail, and effective communication help in interpreting historical contexts and presenting findings clearly. These skills are essential for producing rigorous scholarship, contributing to the field, and educating others about the impact of design over time.
What are popular job titles related to Design History jobs in Indiana? For Design History jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Design History jobs in Indiana look for? The top searched job categories for Design History jobs in Indiana are:
Design History jobs near you
Infographic showing various Design History job openings in Indiana as of August 2026, with employment types broken down into 87% Full Time, 8% Part Time, and 5% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution.

Design Quality Engineer

Prophecy Technologies

Indianapolis, IN • On-site, Remote

Full-time

Posted 11 days ago

Job description

Role Overview:
The Design Quality Engineer will play a crucial role in supporting quality activities throughout the medical device product development lifecycle. This position requires a strong understanding of Design Control requirements and regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971, ensuring compliance and maintaining Design History File (DHF) documentation and risk management processes.
Key Responsibilities:
  • Support quality activities throughout the product development lifecycle.
  • Review and maintain Design History File (DHF) documentation for compliance with regulatory and quality requirements.
  • Lead and support risk management activities including dFMEA, uFMEA, and PHA updates.
  • Ensure traceability between User Needs, Design Inputs, Risk Controls, Verification, Validation, and Design Outputs.
  • Support Design Verification and Validation planning, execution, and documentation reviews.
  • Review Product Characterization, Product Specification (PSD), and CTQ documents.
  • Participate in design reviews and ensure compliance with Design Control processes.
  • Support Cockpit Cognition DHF Build activities, including documentation organization and traceability linkages.
  • Conduct DHF gap assessments and support remediation activities.
  • Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supplier Quality teams.
  • Support CAPA investigations, root cause analysis, and implementation of corrective actions.
  • Ensure compliance with FDA, ISO 13485, ISO 14971, and internal quality procedures.
  • Support internal audits, customer audits, and regulatory inspections.
  • Drive continuous improvement initiatives related to design quality and risk management processes.

Required Skills:
  • Strong understanding of Medical Device Product Development Process and Design Control requirements.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards.
  • Strong knowledge of Design Controls and medical device product development.
  • Experience with Design History File (DHF) development, review, and remediation.
  • Hands-on experience with Risk Management activities including: dFMEA, uFMEA, Preliminary Hazard Analysis (PHA).
  • Experience with Design Verification and Validation (V&V).
  • Understanding of User Needs, Design Inputs, Design Outputs, and Traceability requirements.
  • Experience preparing and reviewing: Product Specification Documents (PSD), Product Characterization documents, CTQ (Critical-to-Quality) documents.
  • Experience with CAPA, Nonconformance, and root cause investigations.
  • Familiarity with PLM systems such as Windchill or Teamcenter.
  • Experience with Cockpit Cognition DHF Build and DHF traceability management.
  • Strong documentation, technical writing, and audit support skills.

Qualifications:
  • Strong understanding of Medical Device Product Development Process and Design Control requirements.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards.

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