Generates design assurance documentation for the project Design History File (DHF). * Develops quality control procedures and inspection methods * Initiates design changes relative to ...
Generates design assurance documentation for the project Design History File (DHF). * Develops quality control procedures and inspection methods * Initiates design changes relative to ...
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 ...
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 ...
Staff R&D Design Engineer
Memphis, TN · On-site
$89K - $148K/yr
Create and maintain design documentation, including design history files, in compliance with regulatory requirements * Conduct or design advanced prototyping and testing * Lead creation and ...
Staff R&D Design Engineer
Memphis, TN · On-site
$89K - $148K/yr
Create and maintain design documentation, including design history files, in compliance with regulatory requirements * Conduct or design advanced prototyping and testing * Lead creation and ...
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 ...
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 ...
Design Quality Engineer
Carlsbad, CA · On-site
Support Design History File establishment, creation, approval and maintenance * Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to ...
Design Quality Engineer
Carlsbad, CA · On-site
Support Design History File establishment, creation, approval and maintenance * Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to ...
Staff R&D Design Engineer
Memphis, TN · Hybrid
$89K - $148K/yr
Create and maintain design documentation, including design history files, in compliance with regulatory requirements * Conduct or design advanced prototyping and testing * Lead creation and ...
Staff R&D Design Engineer
Memphis, TN · Hybrid
$89K - $148K/yr
Create and maintain design documentation, including design history files, in compliance with regulatory requirements * Conduct or design advanced prototyping and testing * Lead creation and ...
Design Quality Engineer III
Maple Grove, MN · On-site
$55/hr
Key Responsibilities • Supports Design History File (DHF) remediation initiatives by assisting with gap assessments, evidence collection, and documentation updates to close design control ...
Design Quality Engineer III
Maple Grove, MN · On-site
$55/hr
Key Responsibilities • Supports Design History File (DHF) remediation initiatives by assisting with gap assessments, evidence collection, and documentation updates to close design control ...
Design Quality Engineer
Carlsbad, CA · Hybrid
Support Design History File establishment, creation, approval and maintenance * Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to ...
Design Quality Engineer
Carlsbad, CA · Hybrid
Support Design History File establishment, creation, approval and maintenance * Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Art and Art History Lecturer Pool - Art History
San Jose, CA · On-site
$8.5K - $10K/mo
In addition, the candidate should also be able to teach lower-division, general survey courses, including the introduction to design history (ARTH 72) and/or the introduction to visual culture (ARTH ...
Art and Art History Lecturer Pool - Art History
San Jose, CA · On-site
$8.5K - $10K/mo
In addition, the candidate should also be able to teach lower-division, general survey courses, including the introduction to design history (ARTH 72) and/or the introduction to visual culture (ARTH ...
Design Assurance Engineer
Saint Paul, MN · On-site
... Design History File records · Lead key equipment qualification efforts · Lead supplier management activities · Review and evaluate non-conforming materials. · Work with vendors to correct ...
Quick apply
Design Assurance Engineer
Saint Paul, MN · On-site
... Design History File records · Lead key equipment qualification efforts · Lead supplier management activities · Review and evaluate non-conforming materials. · Work with vendors to correct ...
... Design History File records · Lead key equipment qualification efforts · Lead supplier management activities · Review and evaluate non-conforming materials. · Work with vendors to correct ...
Quick apply
... Design History File records · Lead key equipment qualification efforts · Lead supplier management activities · Review and evaluate non-conforming materials. · Work with vendors to correct ...
Art and Art History Lecturer Pool - Art History
$8.5K - $10K/mo
In addition, the candidate should also be able to teach lower-division, general survey courses, including the introduction to design history (ARTH 72) and/or the introduction to visual culture (ARTH ...
Art and Art History Lecturer Pool - Art History
$8.5K - $10K/mo
In addition, the candidate should also be able to teach lower-division, general survey courses, including the introduction to design history (ARTH 72) and/or the introduction to visual culture (ARTH ...
... Design (NASAD). Here's what we offer to prospective students: award-winning faculty and an ... D. in art history or equivalent field and teaching experience at the university level; strong ...
... Design (NASAD). Here's what we offer to prospective students: award-winning faculty and an ... D. in art history or equivalent field and teaching experience at the university level; strong ...
Art and Art History Lecturer Pool - History of Contemporary Art
San Jose, CA · On-site
$8.5K - $10K/mo
... Design (NASAD). Here's what we offer to prospective students: award-winning faculty and an ... D. in art history or equivalent field and teaching experience at the university level; strong ...
Art and Art History Lecturer Pool - History of Contemporary Art
San Jose, CA · On-site
$8.5K - $10K/mo
... Design (NASAD). Here's what we offer to prospective students: award-winning faculty and an ... D. in art history or equivalent field and teaching experience at the university level; strong ...
Art and Art History Lecturer Pool - Art History
San Jose, CA · On-site
$8.5K - $10K/mo
In addition, the candidate should also be able to teach lower-division, general survey courses, including the introduction to design history (ARTH 72) and/or the introduction to visual culture (ARTH ...
Art and Art History Lecturer Pool - Art History
San Jose, CA · On-site
$8.5K - $10K/mo
In addition, the candidate should also be able to teach lower-division, general survey courses, including the introduction to design history (ARTH 72) and/or the introduction to visual culture (ARTH ...
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 ...
Quick apply
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 ...
Review, update, and maintain Design History Files (DHFs) and technical documentation. * Perform design assurance activities across all stages of the product lifecycle. * Conduct risk management ...
Quick apply
Review, update, and maintain Design History Files (DHFs) and technical documentation. * Perform design assurance activities across all stages of the product lifecycle. * Conduct risk management ...
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?

Job description
Under routine supervision, primarily responsible for the development of new products and or the enhancement of existing products. Lead or serve as a member of a project team. Involved in creating designs, modeling and drafting utilizing a 3D CAD system. Other responsibilities include assisting in the development processes for Manufacturing, Quality Control, Regulatory and Planning for their particular project.
Essential Duties and Responsibilities
- Designs, develops and processes implants and instruments utilizing Solidworks CAD software.
- Leads the development of new products and manufacturing processes and/or serves as a member of a project team.
- Directs the development of working prototype models to be used for project design evaluation.
- Manage designers or coops
- Generates protocols for testing and analyzing new and current products.
- Generates design assurance documentation for the project Design History File (DHF).
- Develops quality control procedures and inspection methods
- Initiates design changes relative to manufacturability while maintaining critical features of each product for in house manufacturing or vendors
- Leads and/or serves on cross-functional product development teams responsible for new product development from concept through product launch.
- Provides technical input to marketing counterparts on the development of collateral marketing materials
- Provides technical expertise to marketing and sales as to intent of design function.
- Provides technical experience to Regulatory Affairs to support FDA 510K submissions.
- Creates and processes Engineering Change Orders (ECO's)
- Other duties as assigned.
About Alphatec Spine
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Carlsbad, CA, US
Year founded
1990