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Design History Jobs (NOW HIRING)

Aspen Surgical

Design Engineer

Caledonia, MI · On-site

Execute medical device design history file activities to be compliant with applicable regulations. * Provide technical support to other departments and individuals as necessary in the exploration of ...

aspensurgical

Sr Design Engineer

Caledonia, MI · On-site

Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...

Ki Mobility

Design Engineer

Stevens Point, WI · On-site

$65 - $90/hr

Organize and maintain accurate documentation, design data, and digital records for design history files in accordance with ISO 13485 and FDA (21 CFR Part 820) standards. * Prepare technical ...

Alphatec Spine

Senior Design Engineer

Carlsbad, CA · On-site

Generates design assurance documentation for the project Design History File (DHF). * Develops quality control procedures and inspection methods * Initiates design changes relative to ...

Actalent

Mechanical Design Engineer

Golden, CO

$78K - $106K/yr

Author, maintain, and organize Design History Files (DHF) and other design control documentation in accordance with FDA and ISO requirements. * Support internal and external audits and inspections by ...

IPG Photonics

Design Assurance Engineer

Marlborough, MA · On-site

Support Design Engineering in the creation of Design History and Technical Files * Interact with third-party test houses that conduct compliance testing of IPG products * Assist regulatory department ...

IPG Photonics

Design Assurance Engineer

Marlborough, MA · On-site

Support Design Engineering in the creation of Design History and Technical Files * Interact with third-party test houses that conduct compliance testing of IPG products * Assist regulatory department ...

Aspen Surgical

Sr Design Engineer

Caledonia, MI · On-site

Execute medical device design history file activities to be compliant with applicable regulations * Conduct the development and evaluation of medical device designs which meet defined product ...

avalign

Sr. Design Quality Engineer

Fort Wayne, IN · On-site

Ensure required design documentation is retained in design history files and technical files to support regulatory submissions and audits. * Support and maintain all regulatory filings for all ...

search-tactics

Sr CAD Designer

North Attleboro, MA · On-site

$35 - $48/hr

Maintain Design History Files (DHF) and support design reviews and verification activities. * Mentor junior designers and support CAD standards and continuous improvement initiatives. Position ...

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Design History information

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 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 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.

More about Design History jobs

What cities are hiring for Design History jobs?

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What states have the most Design History jobs?

States with the most job openings for Design History jobs include:

What job categories do people searching Design History jobs look for?

The top searched job categories for Design History jobs are:

Design History jobs near you
Infographic showing various Design History job openings in the United States as of August 2026, with employment types broken down into 90% Full Time, 7% Part Time, and 3% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution.

Design Engineer

Aspen Surgical

Caledonia, MI • On-site

Full-time

Re-posted 15 days ago

Job description

About Aspen
We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people's lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.
Summary
The Design Engineer is responsible for Designing medical devices to support the growth, cost profile, and business continuity of Aspen Surgical products while working in a collaborative team environment.
In This Position, You Will Have the Opportunity to:
Medical Device Product Development
  • Lead projects and evaluate design changes related to existing products to maintain business continuity.
  • Develop and evaluate medical device designs which meet defined product requirements and are optimized for safe clinical solutions, production, reliability, and overall cost effectiveness for the business.
  • Execute medical device design history file activities to be compliant with applicable regulations.
  • Provide technical support to other departments and individuals as necessary in the exploration of new opportunities, complaints etc.
  • Evaluate proposed changes to existing products and complete deliverables required to implement change through individual efforts or cross-functional teams.
  • Ensure product changes meet regulations as well as internal and external customer requirements.
  • Troubleshoot and problem-solve efforts related to product design.
  • Conduct thorough engineering and data analysis.

Project Management
  • Manage project schedules, budgets, mitigating risks, and efficient solutioning of issues.
  • Communicate project plans, track tasks, and manage time to meet project deadlines.
  • Communicate with leaders status of projects in a clear and efficient manner.

Global Collaboration
  • Work closely with the portfolio managers to understand clinical and commercial impacts.
  • Strong communication skills to convey design concepts to clinicians to obtain design direction
  • Work with manufacturing throughout the development phases to ensure that products are produced in a safe, efficacious, and quality manner while keeping within established time frames
  • Work with finance to develop product costing to understand impacts of material/design selections
  • Interface with vendors, manufacturing facilities, and various internal groups to resolve design and manufacturing issues of new and existing products.

What You Need to Succeed in This Position
  • Bachelor of Science Degree in Engineering is required
  • A minimum of three to five years of medical device engineering experience
  • Regulated industry experience that includes, but not limited to, FDA 21CFR820.30, ISO 13485, ISO 14971, MDSAP and European MDD/MDR requirements.
  • Preferred working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards
  • Strong familiarity with the methods of Risk Management and Failure Mode Effects Analysis (FMEA)
  • Working knowledge of design history & technical file within an auditing environment.
  • Working knowledge of statistical analysis of data used to meet or define design criteria
  • Project management experience to effectively manage and complete multiple projects simultaneously
  • Preferred involvement with invention disclosures or patents
  • Business case development for product costing as it pertains to design
  • Preferred experience using engineering programs such as SolidWorks, Minitab, TOPS, similar.
  • Strong teamwork and effective communication to enhance a positive culture.
  • Ability to effectively communicate and collaborate globally.
  • Drives a culture of clinical safety and quality first.
  • Mitigates risks during the lifetime of the projects
  • Engage in continuous education to maintain job knowledge in medical device design & development
  • Excellent computer skills including but not limited to Microsoft Office Suite
  • Ability to travel up to 15% required.

We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.

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