Input and review for design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client ...
Input and review for design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client ...
Development Engineer
Warsaw, IN · On-site
Supports Design History File and Risk Management File creation and maintenance * Work directly with surgeons and surgical staff in an Operating Room environment to generate and validate user needs.
Development Engineer
Warsaw, IN · On-site
Supports Design History File and Risk Management File creation and maintenance * Work directly with surgeons and surgical staff in an Operating Room environment to generate and validate user needs.
Assistant Teaching Professor of Art History
Muncie, IN · On-site
$52K - $55K/yr
Programs at the BA, BS, and BFA levels include art education, art history, graphic design, animation production, illustration, game art/design, visual effects, and a studio art program that includes ...
Assistant Teaching Professor of Art History
Muncie, IN · On-site
$52K - $55K/yr
Programs at the BA, BS, and BFA levels include art education, art history, graphic design, animation production, illustration, game art/design, visual effects, and a studio art program that includes ...
Component Design Engineer
Indianapolis, IN · Hybrid
$98K - $160K/yr
Component Design Engineer Working Pattern: Full time Working location: Indianapolis, IN/Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
Component Design Engineer
Indianapolis, IN · Hybrid
$98K - $160K/yr
Component Design Engineer Working Pattern: Full time Working location: Indianapolis, IN/Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
Component Design Engineer
Indianapolis, IN · On-site
$98K - $160K/yr
Component Design Engineer Working Pattern: Full time Working location: Indianapolis, IN/Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
Component Design Engineer
Indianapolis, IN · On-site
$98K - $160K/yr
Component Design Engineer Working Pattern: Full time Working location: Indianapolis, IN/Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
Mechanical/Structural Design Engineer
$74K - $100K/yr
With a 56-year history, Bergvik is growing and strengthening its design and engineering capabilities in North America while maintaining its focus on resilient infrastructure and mission-critical ...
New
Mechanical/Structural Design Engineer
$74K - $100K/yr
With a 56-year history, Bergvik is growing and strengthening its design and engineering capabilities in North America while maintaining its focus on resilient infrastructure and mission-critical ...
New
Mechanical/Structural Design Engineer
South Bend, IN · On-site
$75K - $100K/yr
With a 56-year history, Bergvik is growing and strengthening its design and engineering capabilities in North America whilemaintaining its focus on resilient infrastructure and mission-critical ...
New
Quick apply
Mechanical/Structural Design Engineer
South Bend, IN · On-site
$75K - $100K/yr
With a 56-year history, Bergvik is growing and strengthening its design and engineering capabilities in North America whilemaintaining its focus on resilient infrastructure and mission-critical ...
New
Mechanical Design Engineer
Indianapolis, IN · On-site
$66K - $107K/yr
Mechanical Design Engineer Working Pattern: Full time Working location: Indianapolis, IN./Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
Mechanical Design Engineer
Indianapolis, IN · On-site
$66K - $107K/yr
Mechanical Design Engineer Working Pattern: Full time Working location: Indianapolis, IN./Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
Mechanical Design Engineer
Indianapolis, IN · Hybrid
$66K - $107K/yr
Mechanical Design Engineer Working Pattern: Full time Working location: Indianapolis, IN./Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
Mechanical Design Engineer
Indianapolis, IN · Hybrid
$66K - $107K/yr
Mechanical Design Engineer Working Pattern: Full time Working location: Indianapolis, IN./Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
Senior Component Design Engineer: Turbomachinery - Cold End Design
Indianapolis, IN · On-site
$114.40 - $185.90/hr
Senior Component Design Engineer: Turbomachinery - Cold End Design (Fans, Compressors, and ... We want to ensure that the excellence and ingenuity that has shaped our history continues into our ...
Senior Component Design Engineer: Turbomachinery - Cold End Design
Indianapolis, IN · On-site
$114.40 - $185.90/hr
Senior Component Design Engineer: Turbomachinery - Cold End Design (Fans, Compressors, and ... We want to ensure that the excellence and ingenuity that has shaped our history continues into our ...
LibertyWorks SEE Design Engineer
Indianapolis, IN · Hybrid
$73K - $118K/yr
We want to ensure that the excellence and ingenuity that has shaped our history continues into our ... Drive coordination of effort between the design, purchasing, manufacturing engineering teams with ...
LibertyWorks SEE Design Engineer
Indianapolis, IN · Hybrid
$73K - $118K/yr
We want to ensure that the excellence and ingenuity that has shaped our history continues into our ... Drive coordination of effort between the design, purchasing, manufacturing engineering teams with ...
LibertyWorks SEE Design Engineer
Indianapolis, IN · On-site
$73K - $118K/yr
We want to ensure that the excellence and ingenuity that has shaped our history continues into our ... Drive coordination of effort between the design, purchasing, manufacturing engineering teams with ...
LibertyWorks SEE Design Engineer
Indianapolis, IN · On-site
$73K - $118K/yr
We want to ensure that the excellence and ingenuity that has shaped our history continues into our ... Drive coordination of effort between the design, purchasing, manufacturing engineering teams with ...
Software Quality Engineer
Indianapolis, IN · On-site
$55 - $64/hr
Support regulatory filings and registrations, including 510(k) submissions and Design History File (DHF) creation * Provide technical support for audits of software suppliers and consultants ...
Software Quality Engineer
Indianapolis, IN · On-site
$55 - $64/hr
Support regulatory filings and registrations, including 510(k) submissions and Design History File (DHF) creation * Provide technical support for audits of software suppliers and consultants ...
Mechanical Design Engineer
Indianapolis, IN · Hybrid
$66K - $107K/yr
Mechanical Design Engineer Working Pattern: Full time Working location: Indianapolis, IN./Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
Mechanical Design Engineer
Indianapolis, IN · Hybrid
$66K - $107K/yr
Mechanical Design Engineer Working Pattern: Full time Working location: Indianapolis, IN./Hybrid (3 ... our history continues into our future. It's a bold pursuit, and we never stop striving to go ...
AE Defense Fans & Compressors Design Engineer
Indianapolis, IN · On-site
$98K - $160K/yr
Experience with generic design processes as well as component specific design guidance Our vision is to ensure that the quality and dynamism that shaped our history continues into our future. It's a ...
AE Defense Fans & Compressors Design Engineer
Indianapolis, IN · On-site
$98K - $160K/yr
Experience with generic design processes as well as component specific design guidance Our vision is to ensure that the quality and dynamism that shaped our history continues into our future. It's a ...
Connector Product Design Engineer
New Albany, IN · On-site
$119K - $143K/yr
Design the Next Generation of Interconnect Solutions Are you an engineer who thrives on solving ... history or genetic information, or any other status protected by applicable laws.Privacy Policy:
Connector Product Design Engineer
New Albany, IN · On-site
$119K - $143K/yr
Design the Next Generation of Interconnect Solutions Are you an engineer who thrives on solving ... history or genetic information, or any other status protected by applicable laws.Privacy Policy:
Mechanical/Structural Design Engineer
South Bend, IN · On-site
$75K - $100K/yr
S. With a 56-year history, Bergvik is growing and strengthening its engineering capabilities in ... Design and evaluate steel members, base plates, footplates, brackets, adapter plates, bolted ...
New
Mechanical/Structural Design Engineer
South Bend, IN · On-site
$75K - $100K/yr
S. With a 56-year history, Bergvik is growing and strengthening its engineering capabilities in ... Design and evaluate steel members, base plates, footplates, brackets, adapter plates, bolted ...
New
AE Defense Fans & Compressors Design Engineer
Indianapolis, IN · On-site
$98K - $160K/yr
Experience with generic design processes as well as component specific design guidance Our vision is to ensure that the quality and dynamism that shaped our history continues into our future. It's a ...
AE Defense Fans & Compressors Design Engineer
Indianapolis, IN · On-site
$98K - $160K/yr
Experience with generic design processes as well as component specific design guidance Our vision is to ensure that the quality and dynamism that shaped our history continues into our future. It's a ...
Design Records Specialist
Muncie, IN · On-site
$38K - $42K/yr
Position Title: Design Records Specialist Compensation: $38,376.00 - 42,302.00 Department ... Bachelor's degree or equivalent in library science, records management, history , museum studies or ...
Design Records Specialist
Muncie, IN · On-site
$38K - $42K/yr
Position Title: Design Records Specialist Compensation: $38,376.00 - 42,302.00 Department ... Bachelor's degree or equivalent in library science, records management, history , museum studies or ...
Design Records Specialist
Muncie, IN · On-site
$38K - $42K/yr
Position Title: Design Records Specialist Compensation: $38,376.00 - 42,302.00 Department ... Bachelor's degree or equivalent in library science, records management, history , museum studies or ...
New
Design Records Specialist
Muncie, IN · On-site
$38K - $42K/yr
Position Title: Design Records Specialist Compensation: $38,376.00 - 42,302.00 Department ... Bachelor's degree or equivalent in library science, records management, history , museum studies or ...
New
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 25 days ago
Job description
Working at Freudenberg: We will wow your world!
Responsibilities:Lead development of accuratemanufacturing cost models, make-vs-buy decisions, work-center costs, and support quote generation and pricing strategy for new business or large sustaining initiatives.
Establish, track, and report key performance metrics for development, project progression, and launch; champion continuous-improvement and Lean/Six Sigma activities to boost quality, delivery, and cost.
Gather and translate user, customer, clinician, and/or market needs and inputs into clear product and business requirements; present data-driven recommendations to stakeholders.
Maintain project documentation in line with internal procedures and notified-body expectations, supporting audits and ensuring robust change-control and traceability. Prepare reports and project summaries to communicate the status of projects on a regular basis.
Provide technical and project-management leadership, set priorities, allocate tasks, mentor team members, and foster a culture of efficiency, innovation, and regulatory excellence across the organization.
Manages a few discrete projects with teams, operating within a defined PDP process delivering to achieve defined scope, schedule, and budget performance goals.
Familiarity with and managing efforts for compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements.
Input and review for design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client, regulatory, and business needs.
Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
3+ years' experience in Medical Device or related industry
2+ years' experience in leading teams in a manufacturing or engineering environment, with demonstrated experience of managing work within a project plan framework, including managing a schedule, budget, scope, progress, and reporting.
Understanding of scientific principles and manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used.
Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971, and 45001. Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States, and EU MDR).
Demonstrated experience using Lean/Six Sigma tools as necessary for new and continuous improvement projects.
Demonstrated experience providing leadership and managing multiple projects of low to medium complexity.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
Freudenberg Medical LLC