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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Design Engineer, R&D - Mechanical
Portage, MI · On-site
$69K - $110K/yr
Creating and/or refining engineering documentation, such as the Design History File and the Device Master Record. * Following, learning, and contributing to R&D procedures, such as design controls ...
Design Engineer, R&D - Mechanical
Portage, MI · On-site
$69K - $110K/yr
Creating and/or refining engineering documentation, such as the Design History File and the Device Master Record. * Following, learning, and contributing to R&D procedures, such as design controls ...
Demonstrated experience in areas that would complement web and print such as marketing, entrepreneurism, textile design, environment design, art and design history, storyboarding, traditional drawing ...
Demonstrated experience in areas that would complement web and print such as marketing, entrepreneurism, textile design, environment design, art and design history, storyboarding, traditional drawing ...
Demonstrated experience in areas that would complement web and print such as marketing, entrepreneurism, textile design, environment design, art and design history, storyboarding, traditional drawing ...
Demonstrated experience in areas that would complement web and print such as marketing, entrepreneurism, textile design, environment design, art and design history, storyboarding, traditional drawing ...
Adjunct, Graphic Design
Port Huron, MI · On-site
Demonstrated experience in areas that would complement web and print such as marketing, entrepreneurism, textile design, environment design, art and design history, storyboarding, traditional drawing ...
Adjunct, Graphic Design
Port Huron, MI · On-site
Demonstrated experience in areas that would complement web and print such as marketing, entrepreneurism, textile design, environment design, art and design history, storyboarding, traditional drawing ...
Engineer I - Detroit MI
Detroit, MI · On-site
... Design History Files Analyzing data to support design acceptance, performance capability, and failure analysis Creating and driving test protocols, methods, and reports Transferring of technical ...
Engineer I - Detroit MI
Detroit, MI · On-site
... Design History Files Analyzing data to support design acceptance, performance capability, and failure analysis Creating and driving test protocols, methods, and reports Transferring of technical ...
Staff Mechanical Engineer, R&D
Portage, MI · Hybrid
$89K - $148K/yr
Create andmaintainengineering documentation, including Design History Files. * Collaborate cross-functionallyto drive projects from concept through launch. What You Will Need Required Qualifications
Staff Mechanical Engineer, R&D
Portage, MI · Hybrid
$89K - $148K/yr
Create andmaintainengineering documentation, including Design History Files. * Collaborate cross-functionallyto drive projects from concept through launch. What You Will Need Required Qualifications
Product Safety Engineer
Portage, MI · On-site
$69K - $110K/yr
Independently create or refine engineering documentation, such as the Design History file What You Need (Required Qualifications): * Bachelor's degree in EE or related discipline and 0+ years of work ...
Product Safety Engineer
Portage, MI · On-site
$69K - $110K/yr
Independently create or refine engineering documentation, such as the Design History file What You Need (Required Qualifications): * Bachelor's degree in EE or related discipline and 0+ years of work ...
Staff Mechanical Engineer, R&D
Portage, MI · On-site
$89K - $148K/yr
Create and maintain engineering documentation, including Design History Files. * Collaborate cross-functionally to drive projects from concept through launch. What You Will Need Required ...
Staff Mechanical Engineer, R&D
Portage, MI · On-site
$89K - $148K/yr
Create and maintain engineering documentation, including Design History Files. * Collaborate cross-functionally to drive projects from concept through launch. What You Will Need Required ...
Product Safety Engineer
Grand Rapids, MI · On-site
$69K - $110K/yr
Independently create or refine engineering documentation, such as the Design History file What You Need (Required Qualifications): * Bachelor's degree in EE or related discipline and 0+ years of work ...
Product Safety Engineer
Grand Rapids, MI · On-site
$69K - $110K/yr
Independently create or refine engineering documentation, such as the Design History file What You Need (Required Qualifications): * Bachelor's degree in EE or related discipline and 0+ years of work ...
Senior Process Engineer II
Ann Arbor, MI · On-site
$105.06 - $139.59/hr
Maintain documentation and traceability for all engineering activities, including design history files and risk assessments. * Utilizes the systems and processes in place to attract, develop, engage ...
Senior Process Engineer II
Ann Arbor, MI · On-site
$105.06 - $139.59/hr
Maintain documentation and traceability for all engineering activities, including design history files and risk assessments. * Utilizes the systems and processes in place to attract, develop, engage ...
Engineer I - Detroit MI
Detroit, MI · On-site
$100K/yr
... Design History Files Analyzing data to support design acceptance, performance capability, and failure analysis Creating and driving test protocols, methods, and reports Transferring of technical ...
Engineer I - Detroit MI
Detroit, MI · On-site
$100K/yr
... Design History Files Analyzing data to support design acceptance, performance capability, and failure analysis Creating and driving test protocols, methods, and reports Transferring of technical ...
Engineer I - Detroit MI
Detroit, MI · On-site
$100K/yr
... Design History Files Analyzing data to support design acceptance, performance capability, and failure analysis Creating and driving test protocols, methods, and reports Transferring of technical ...
Engineer I - Detroit MI
Detroit, MI · On-site
$100K/yr
... Design History Files Analyzing data to support design acceptance, performance capability, and failure analysis Creating and driving test protocols, methods, and reports Transferring of technical ...
The CAD Designer / Engineer's key responsibilities include: 1. Creating new CAD models of future ... Founded in Shanghai in 1936, Yanfeng's history of innovation and craftsmanship have since expanded ...
The CAD Designer / Engineer's key responsibilities include: 1. Creating new CAD models of future ... Founded in Shanghai in 1936, Yanfeng's history of innovation and craftsmanship have since expanded ...
Design Engineer
Novi, MI · On-site
The CAD Designer / Engineer's key responsibilities include: 1. Creating new CAD models of future ... Founded in Shanghai in 1936, Yanfeng's history of innovation and craftsmanship have since expanded ...
Design Engineer
Novi, MI · On-site
The CAD Designer / Engineer's key responsibilities include: 1. Creating new CAD models of future ... Founded in Shanghai in 1936, Yanfeng's history of innovation and craftsmanship have since expanded ...
Staff Software Systems Engineer- Medical Device
Grand Rapids, MI · On-site
$102K - $171K/yr
Contribute to Design History File (DHF) documentation and ensure adherence to medical device regulations, design controls, and quality system requirements. What You Need (Required Qualifications)
Staff Software Systems Engineer- Medical Device
Grand Rapids, MI · On-site
$102K - $171K/yr
Contribute to Design History File (DHF) documentation and ensure adherence to medical device regulations, design controls, and quality system requirements. What You Need (Required Qualifications)
Staff Software Systems Engineer- Medical Device
Portage, MI · On-site
$102K - $171K/yr
Contribute to Design History File (DHF) documentation and ensure adherence to medical device regulations, design controls, and quality system requirements. What You Need (Required Qualifications)
Staff Software Systems Engineer- Medical Device
Portage, MI · On-site
$102K - $171K/yr
Contribute to Design History File (DHF) documentation and ensure adherence to medical device regulations, design controls, and quality system requirements. What You Need (Required Qualifications)
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?
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.
What are popular job titles related to Design History jobs in Michigan? For Design History jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Design History jobs in Michigan look for? The top searched job categories for Design History jobs in Michigan are:
Full-time
Posted 17 days ago
Job description
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.
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In This Position, You Will Have the Opportunity to:
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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.
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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.
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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.