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 ...
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 ...
Create and maintain engineering documentation, including schematics, specifications, test protocols, reports, and design history file documentation. * Support all phases of product development, from ...
New
Create and maintain engineering documentation, including schematics, specifications, test protocols, reports, and design history file documentation. * Support all phases of product development, from ...
New
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 ...
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 ...
Art and Art History Lecturer Pool - History of Contemporary Art
San Jose, CA · On-site
$8.5K - $10K/mo
Department Summary The Department of Art and Art History, established in 1911, offers BA, BFA, MA, and MFA degrees and is accredited by the National Association of Schools of Art and Design (NASAD)
Art and Art History Lecturer Pool - History of Contemporary Art
San Jose, CA · On-site
$8.5K - $10K/mo
Department Summary The Department of Art and Art History, established in 1911, offers BA, BFA, MA, and MFA degrees and is accredited by the National Association of Schools of Art and Design (NASAD)
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 Studio Intern
New York, NY · On-site
$18 - $20/hr
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
$18 - $20/hr
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 ...
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 ...
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 ...
Product Development Engineer
$50 - $56/hr
Experience with Design History Files (DHF) and design controls * Experience supporting commercialized/on-market products * Strong technical writing, data analysis, and problem-solving skills
Quick apply
Product Development Engineer
$50 - $56/hr
Experience with Design History Files (DHF) and design controls * Experience supporting commercialized/on-market products * Strong technical writing, data analysis, and problem-solving skills
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 ...
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 ...
Senior Design Quality Engineer
Marlton, NJ · On-site
$88K - $120K/yr
Complete design history file verifications throughout each design control phase * Author non-conformance reports and CAPAs; investigate quality issues and complaints About you * Be able to do the job ...
Senior Design Quality Engineer
Marlton, NJ · On-site
$88K - $120K/yr
Complete design history file verifications throughout each design control phase * Author non-conformance reports and CAPAs; investigate quality issues and complaints About you * Be able to do the job ...
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 ...
Adjunct Faculty - Digital Art & Design (Multiple Specialties)
Manhattan, NY · On-site
$99 - $108/hr
Candidates should connect historical context to digital/interactive/AI-enhanced design practice. • Motion Graphics (LI Campus Only) Teach BFA courses in the fundamentals of motion design, animation ...
Adjunct Faculty - Digital Art & Design (Multiple Specialties)
Manhattan, NY · On-site
$99 - $108/hr
Candidates should connect historical context to digital/interactive/AI-enhanced design practice. • Motion Graphics (LI Campus Only) Teach BFA courses in the fundamentals of motion design, animation ...
Candidates should connect historical context to digital/interactive/AI-enhanced design practice. * Motion Graphics (LI Campus Only) Teach BFA courses in the fundamentals of motion design, animation ...
Candidates should connect historical context to digital/interactive/AI-enhanced design practice. * Motion Graphics (LI Campus Only) Teach BFA courses in the fundamentals of motion design, animation ...
Design Assurance Engineer
Woburn, MA · On-site
... History file and Design Transfer deliverables • Lead risk management activities including FMEA, risk mitigation, and effectiveness checks • Support design transfer, process validation, and test ...
Design Assurance Engineer
Woburn, MA · On-site
... History file and Design Transfer deliverables • Lead risk management activities including FMEA, risk mitigation, and effectiveness checks • Support design transfer, process validation, and test ...
Manage Design History file and Design Transfer deliverables Lead risk management activities including FMEA, risk mitigation, and effectiveness checks Support design transfer, process validation, and ...
Manage Design History file and Design Transfer deliverables Lead risk management activities including FMEA, risk mitigation, and effectiveness checks Support design transfer, process validation, and ...
Senior Design Engineer
Carlsbad, CA · On-site
$85K - $95K/yr
Generates design assurance documentation for the project Design History File (DHF). * Develops quality control procedures and inspection methods * Initiates design changes relative to ...
Senior Design Engineer
Carlsbad, CA · On-site
$85K - $95K/yr
Generates design assurance documentation for the project Design History File (DHF). * Develops quality control procedures and inspection methods * Initiates design changes relative to ...
Engineering - Circuit Design Engineer
Orlando, FL · On-site
$71.83/hr
... history within the PLM system - Support environmental qualification (vibration, shock, thermal, radiation) and drive design improvements Required Skills and Experience - Bachelor's degree in ...
Engineering - Circuit Design Engineer
Orlando, FL · On-site
$71.83/hr
... history within the PLM system - Support environmental qualification (vibration, shock, thermal, radiation) and drive design improvements Required Skills and Experience - Bachelor's degree in ...
Design History information
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.
What are some common challenges faced by professionals working in design history roles within organizations?
What is design history?
What are the key skills and qualifications needed to thrive as a design historian, and why are they important?

Full-time
Re-posted 6 days ago
Job description
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.