Develops and maintains Design History Files in accordance with client procedures and regulations * Interfaces with clients to define and achieve design objectives * Proactively works with all parties ...
Develops and maintains Design History Files in accordance with client procedures and regulations * Interfaces with clients to define and achieve design objectives * Proactively works with all parties ...
Product Development Engineering Scientist
Boston, MA · On-site
$106 - $158/hr
Collaborate with cross-functional teams to author design history documentation of combination drug-device and/or biologic device products. * Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and ...
Product Development Engineering Scientist
Boston, MA · On-site
$106 - $158/hr
Collaborate with cross-functional teams to author design history documentation of combination drug-device and/or biologic device products. * Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and ...
Product Development Engineer / Design Quality Engi
Marlborough, MA · On-site
$85K - $100K/yr
Design History Files (DHF) * Technical Files * Design specifications * Verification and validation documentation Qualifications & Requirements: * Bachelor's degree in Engineering, Science, or a ...
Product Development Engineer / Design Quality Engi
Marlborough, MA · On-site
$85K - $100K/yr
Design History Files (DHF) * Technical Files * Design specifications * Verification and validation documentation Qualifications & Requirements: * Bachelor's degree in Engineering, Science, or a ...
Adjunct Faculty - Game Design
Troy, AL · On-site
These classes may include History of Game Design, History Through Games, Game Development, Special Topics in Game Design and Development, and the Game Design and Development capstone class. The ...
Adjunct Faculty - Game Design
Troy, AL · On-site
These classes may include History of Game Design, History Through Games, Game Development, Special Topics in Game Design and Development, and the Game Design and Development capstone class. The ...
Position Summary The Senior R&D Engineer plays a high impact role from concept to launch of innovative surgical products while leading project core teams through Design History File generation and ...
Position Summary The Senior R&D Engineer plays a high impact role from concept to launch of innovative surgical products while leading project core teams through Design History File generation and ...
Design Engineer
Carlsbad, CA · On-site
$78 - $90/hr
Update and write documentation/design history files to support designs in accordance with Design Control and Risk Management procedures. * Work with Engineering Services team to generate and analyze ...
Design Engineer
Carlsbad, CA · On-site
$78 - $90/hr
Update and write documentation/design history files to support designs in accordance with Design Control and Risk Management procedures. * Work with Engineering Services team to generate and analyze ...
This role focuses on supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The specialist will be responsible for reviewing ...
This role focuses on supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The specialist will be responsible for reviewing ...
Design Studio Intern
New York, NY · On-site
Enthusiasm for textiles, interior design, design and art history, and continuous learning * Some experience with Photoshop (ideally textile specific) or other textile software a plus * Strong hand ...
Design Studio Intern
New York, NY · On-site
Enthusiasm for textiles, interior design, design and art history, and continuous learning * Some experience with Photoshop (ideally textile specific) or other textile software a plus * Strong hand ...
Device Design Engineer
Tempe, AZ · On-site
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedures like design controls and risk management, per the Quality Management System.
Quick apply
Device Design Engineer
Tempe, AZ · On-site
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedures like design controls and risk management, per the Quality Management System.
Device Design Engineer
Tempe, AZ · On-site
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedures like design controls and risk management, per the Quality Management System.
Quick apply
Device Design Engineer
Tempe, AZ · On-site
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedures like design controls and risk management, per the Quality Management System.
Medical Device Systems Engineer
$55 - $60/hr
Strong experience with Design Controls and Design History File (DHF) documentation in a regulated environment. * Experience working in a cross-functional, matrixed organization with strong ...
Quick apply
Medical Device Systems Engineer
$55 - $60/hr
Strong experience with Design Controls and Design History File (DHF) documentation in a regulated environment. * Experience working in a cross-functional, matrixed organization with strong ...
Device Design Engineer
Tempe, AZ · On-site
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedures like design controls and risk management, per the Quality Management System.
Quick apply
Device Design Engineer
Tempe, AZ · On-site
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedures like design controls and risk management, per the Quality Management System.
Device Design Engineer
Tempe, AZ · On-site
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedures like design controls and risk management, per the Quality Management System.
Device Design Engineer
Tempe, AZ · On-site
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedures like design controls and risk management, per the Quality Management System.
Senior Electrical Design Engineer - Neurosurgical R&D
Portage, MI · On-site
$77 - $130/hr
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedure like design controls and risk management, per the Quality Management System * Work ...
Senior Electrical Design Engineer - Neurosurgical R&D
Portage, MI · On-site
$77 - $130/hr
Independently create or refine engineering documentation, such as the Design History file * Follow R&D procedure like design controls and risk management, per the Quality Management System * Work ...
Circuit Design Engineer
Orlando, FL · Hybrid
$71/hr
Managing configuration control, documentation, and change requests in the PLM system to maintain a robust, audit ready design history. * Supporting environmental qualification (vibration, shock ...
Circuit Design Engineer
Orlando, FL · Hybrid
$71/hr
Managing configuration control, documentation, and change requests in the PLM system to maintain a robust, audit ready design history. * Supporting environmental qualification (vibration, shock ...
Design History File and Traceability * Establish and maintain processes and SOPs that support complete, accurate, and audit-ready Design History Files from user needs through design validation.
Design History File and Traceability * Establish and maintain processes and SOPs that support complete, accurate, and audit-ready Design History Files from user needs through design validation.
Circuit Design Engineer
Orlando, FL · Hybrid
$71/hr
Managing configuration control, documentation, and change requests in the PLM system to maintain a robust, audit ready design history. * Supporting environmental qualification (vibration, shock ...
Circuit Design Engineer
Orlando, FL · Hybrid
$71/hr
Managing configuration control, documentation, and change requests in the PLM system to maintain a robust, audit ready design history. * Supporting environmental qualification (vibration, shock ...
Maintain design history files and technical documentation * Support FDA, CE, and other regulatory submissions * Analyze test data and help engineering teams make design decisions * Collaborate with ...
Maintain design history files and technical documentation * Support FDA, CE, and other regulatory submissions * Analyze test data and help engineering teams make design decisions * Collaborate with ...
Maintain design history files and technical documentation * Support FDA, CE, and other regulatory submissions * Analyze test data and help engineering teams make design decisions * Collaborate with ...
Maintain design history files and technical documentation * Support FDA, CE, and other regulatory submissions * Analyze test data and help engineering teams make design decisions * Collaborate with ...
Design Engineer, Packaging
Gainesville, FL · On-site
$123K/yr
Areas of involvement include regulatory submissions, Design History Files, package/case evaluation, package/case validation and testing, manufacturing or supplier support, quality control and ...
Design Engineer, Packaging
Gainesville, FL · On-site
$123K/yr
Areas of involvement include regulatory submissions, Design History Files, package/case evaluation, package/case validation and testing, manufacturing or supplier support, quality control and ...
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?
| Aspect | Design History | Design Documentation |
|---|---|---|
| Purpose | Tracks the evolution and decisions of a design project over time | Provides detailed records of design specifications, drawings, and instructions |
| Focus | Process, revisions, and rationale behind design changes | Finalized details, technical data, and implementation guidelines |
| Work Environment | Design teams, project management, product development | Engineering, manufacturing, quality assurance |
| Common Usage | Used to document design evolution for future reference or audits | Used 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?
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What job categories do people searching Design History jobs look for?
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Full-time
Re-posted 4 days ago
Job description
Description
Essential Responsibilities:
Requirements
Qualifications:
This position will involve all aspects of product design and project management including, but not limited to, client consultation, vendor selection and management, marketing support, and post-market surveillance.
Essential Responsibilities:
- Leads and/or participates in project teams for the design and development of medical devices.
- Develops and maintains Design History Files in accordance with client procedures and regulations
- Interfaces with clients to define and achieve design objectives
- Proactively works with all parties throughout the product development lifecycle to successfully achieve milestones
- Interfaces with quality, operations, and external vendors to ensure manufactured products meet design intent
- Compiles, prepares, and presents information for project updates and technical presentations
- Assists in resolving complex engineering problems and providing sound solutions to clients
Requirements
Qualifications:
- Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, or similar discipline
- Minimum 4 years of related work experience in the medical device industry (spine/orthopedic experience preferred)
- Extensive 2D/3D CAD design experience in Solidworks, Siemens NX, or similar software
- Experience with Geometric Dimensioning and Tolerancing (GD&T) per ASME Y14.5 and designing components for manufacturability
- Ability to coordinate the manufacturing of design prototypes and production parts with external vendors
- Familiarity with verification and validation testing of medical devices
- FEA (Finite Element Analysis) experience a plus
- Experience designing products in a regulated environment including FDA, EU/MDR, ISO, and other relevant regulations
- Understanding of the phases of medical device development in accordance with regulations and industry standard practices
- Excellent interpersonal and written communication skills
- Ability to multitask and efficiently manage multiple projects
- Candidate must be a self-starter, self-motivated, and results-oriented
- Able to work both independently and have with cross-functional teams
- Extensive project management skills with the ability to work against tight timelines
This position will involve all aspects of product design and project management including, but not limited to, client consultation, vendor selection and management, marketing support, and post-market surveillance.