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Design History Jobs in Indiana (NOW HIRING)

Merican

Systems Designer

Warsaw, IN · On-site +1

Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively. Requirements * 5+ years of experience * Strong Experience with Software as a ...

Ametek

Solidworks/PDM Administrator

Pierceton, IN

Understanding of Design History Files (DHF), Device Master Records (DMR), and Change Control processes. * Experience with scripting or automation tools (e.g., PowerShell, PDM Dispatch). * Familiarity ...

NIBCO

Design Engineer

Elkhart, IN · On-site

Headquartered in Northern Indiana, with a manufacturing history that spans over a century, NIBCO ... POSITION INFO: This position is responsible for supporting product design and development ...

NIBCO

Design Engineer

Elkhart, IN

Headquartered in Northern Indiana, with a manufacturing history that spans over a century, NIBCO ... POSITION INFO: This position is responsible for supporting product design and development ...

EHOB INC

Product Development Engineer

Indianapolis, IN · On-site

PDE is responsible for documenting and communicating Designs, Requirements, Implementing Risk Mitigation Strategies and other Specifications in Design History Files (DHF) to support the transition ...

Sazerac Company

Design Engineer

New Albany, IN · On-site

With almost 400 years of rich history, Sazerac Company has thrived as an independent, American ... The design engineer provides technical support throughout the project lifecycle, including concept ...

Sazerac Company

Design Engineer

New Albany, IN

With almost 400 years of rich history, Sazerac Company has thrived as an independent, American ... The Design Engineer is an onsite Monday-Friday role. In this role, you will be responsible for ...

Freudenberg

Project Manager

Jeffersonville, IN

Input and review for design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client ...

Ametek

Solidworks/PDM Administrator

Pierceton, IN · On-site

Understanding of Design History Files (DHF), Device Master Records (DMR), and Change Control processes. * Experience with scripting or automation tools (e.g., PowerShell, PDM Dispatch). * Familiarity ...

samtec

Product Design Engineer

New Albany, IN · On-site

$119.40K - $143.40K/yr

Make significant contributions to design, development, and validation of connector solutions ... history or genetic information, or any other status protected by applicable laws.Privacy Policy:

Samtec, Inc Careers

Product Design Engineer

New Albany, IN · On-site

$119.40K - $143.40K/yr

Make significant contributions to design, development, and validation of connector solutions ... history or genetic information, or any other status protected by applicable laws. Privacy Policy:

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Design History information

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 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 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 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
Systems Designer

Systems Designer

Merican

Warsaw, IN • On-site, Remote

Other

Posted 26 days ago

Job description

Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a publicly traded medical device company. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world
Job Title: Systems Designer
Work Location: Warsaw, Indiana 46580
Duration: 7 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
  • The ideal candidate will have a solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation. You'll play a key role in refining existing documentation and ensuring continued regulatory alignment to support new and existing products.
  • Candidates must have experience with software as a medical device (SaMD).

Duties and Responsibilities
System Design
  • Define the design approach, ensuring alignment with product objectives, user needs, clinical workflows, and system performance.
  • Translate user needs and system requirements into practical design solutions.
  • Lead design discussions and technical reviews, evaluating alternatives and trade-offs.
  • Ensure design decisions address usability, risk mitigation, technical feasibility, and long-term product sustainability.

System Testing
  • Implement and review product verification and validation (V&V) testing, including developing protocols, test methods, and performance specifications.
  • Perform manual and automated testing and document results accurately.

Product Documentation
  • Collaborate with QA, Service, Compliance, and Regulatory teams to meet documentation requirements and ensure cross-functional alignment.
  • Create, review, and maintain risk management files, including cybersecurity risks.
  • Ensure all product requirements are documented, traceable to verifiable tests, and kept up-to-date.
  • Ensure compliance with FDA, ISO, and internal design controls.
  • Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively.

Requirements
  • 5+ years of experience
  • Strong Experience with Software as a Medical Device (SaMD)
  • Strong experience in design controls in a multi-disciplinary organization.
  • Experience drafting and maintaining DHF (design history file) content, including user needs, design inputs, design outputs, traceability matrices, and risk documentation.
  • Able to support risk analysis (e.g. uFMEA, etc.) and contribute to usability planning and design mitigations.
  • Familiarity with ISO 14971 is required, and IEC 62366 preferred.
  • Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team.
  • Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.
  • Must have experience in a regulatory environment with strict compliance.
  • Strong analytical skills and accurate judgment-making skills.
  • Ability to deal effectively with internal and external collaborators.
  • Excellent communications skills; written and verbal.
  • Experience with Codebeamer, Jira, or similar.

Education Requirements
  • Bachelor's degree in engineering or science related field; biomedical engineering preferred.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.
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About Merican

Sourced by ZipRecruiter

Merican is a IT Service consulting firm, specialized in Digital adoption and Business automation. With our diverse collection of skilled and committed consultants, technology companies, businesses and digital experts, we provide our subject expertise and our unique client service approach, a best-in-class global model of delivery suited to the business demands of our clients. We ensure that we implement future-oriented solutions for our clients via investments in people, solutions, technologies, competencies and infrastructure.

Industry

It services

Company size

51 - 200 Employees

Headquarters location

Columbia , MD, US

Year founded

2020

Social media

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