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Design History Jobs (NOW HIRING)

Nextern

Senior Design Assurance Engineer

Maple Grove, MN · On-site

$115K - $130K/yr

DV, pVal, etc..) · Support the transfer of designs from R&D to manufacturing · Create and maintain up-to-date product Design History Files (DHF) · Advise project teams and lead by example in best ...

Enovis

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 ...

avalign

Sr. Design Quality Engineer

Schaumburg, IL

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 ...

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 ...

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 ...

Thogus

Project Engineer- Biomedical Design

Westlake, OH · On-site

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 ...

Troy University

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 ...

Teleflex

Sr. Engineer, Design Dev, R&D

Morrisville, NC · On-site

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 ...

Synkriom

Systems Design Engineer-SaMD- Remote

OR · On-site

$48 - $54/hr

The ideal candidate has a solid foundation in systems engineering and product development within a regulated environment, with hands-on experience drafting and maintaining design history file (DHF ...

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Design History information

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 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 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.
More about Design History jobs
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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 July 2026, with employment types broken down into 89% Full Time, 8% Part Time, and 3% Contract. Highlights an 87% Physical, 3% Hybrid, and 10% Remote job distribution.
Senior Design Assurance Engineer

Senior Design Assurance Engineer

Nextern

Maple Grove, MN • On-site

$115K - $130K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired 1 day ago. Applications are no longer accepted.

Job description

The Senior Design Assurance Engineer is responsible for design quality input and deliverables for new product development programs throughout the product lifecycle. They will also support sustaining activities for investigational and commercial device manufacturing, such as changes, audits, and post-market surveillance ensuring a continuously accurate and compliant Design History File. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.

DUTIES AND RESPONSIBILITIES:

· Project core team member accountable for product development deliverables including, but not limited to:

o Design Controls (plan, inputs/outputs, verification, design review, etc..) per 21 CFR820.30

o Risk Management (Plan/Report, Hazards Analysis, FMEA/Risk Assessment) per ISO 14971

o Equipment and Material Qualification

o Test Method development and validation

· Draft, collaborate, and approve product development deliverables and engineering work orders

· Consult and provide guidance on biocompatibility testing per ISO 10993 or collaborate with outside Contract Research Organization

· Coordinate and execute, as necessary, testing in support of new product development (e.g. DV, pVal, etc..)

· Support the transfer of designs from R&D to manufacturing

· Create and maintain up-to-date product Design History Files (DHF)

· Advise project teams and lead by example in best-practices for Quality and Regulatory compliance

· Proactively identify redundancy and opportunities for efficiency in Quality System requirements

· Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are appropriately documented and executed with a lens towards design, risk, and regulatory compliance

· Receive, investigate, and document product complaints, interacting with customers as applicable

· Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs

· Drive Product Lifecycle Management (PLM) architecture and changes, as needed

Requirements

QUALIFICATIONS:

·Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.

· 5+ years of experience in medical device development, or 3+ years of experience in a Design Assurance or Quality Engineering role

· Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.

· Development project team member on complex medical device development programs, including systems

· Understanding of ISO 14971 and application of risk management to product development and processes.

· Demonstrated technical expertise and leadership in quality.

· High attention to detail, organization, and accuracy.

· Instinctual capability for creative thinking and proposing novel solutions

· Strong ability to communicate (written and verbally) within and across disciplines and organization structures.

· Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..).

· Familiarity with statistical software, such as Minitab, preferred.

· Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)

· Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).

Benefits

Nextern offers excellent benefits to fuel you in building a fulfilling life & career:

    • The expected salary range for this position is between $115,000 - $130,000
    • Health Care Plan (Medical, Dental & Vision)
    • Retirement Plan with Company Match
    • Paid Time Off, Personal Days, AND Birthday Holiday!
    • Lifetime Membership Subsidy and Wellness Resources
    • Life Insurance (Basic, Voluntary & AD&D)
    • Short-Term & Long-Term Disability