Support and manage Design History File (DHF) activities for medical device projects. * Review, update, and maintain Global dFMEA and uFMEA documentation, identifying and mitigating risks. * Develop ...
Support and manage Design History File (DHF) activities for medical device projects. * Review, update, and maintain Global dFMEA and uFMEA documentation, identifying and mitigating risks. * Develop ...
Support Design History File (DHF) activities for medical device development projects. * Review ... Collaborate with Design, Quality, Regulatory, Manufacturing, and Project Management teams to ...
Support Design History File (DHF) activities for medical device development projects. * Review ... Collaborate with Design, Quality, Regulatory, Manufacturing, and Project Management teams to ...
Medical Device Coder
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
$18 - $24/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
$18 - $24/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
S. health plans, retail pharmacies, and pharmacy benefit managers; and millions of healthcare ... Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical ...
Engineering Project Manager
Fishers, IN · On-site
We are a dynamic and innovative medical device startup developing a point-of-care portable blood coagulation testing device. Job Summary: We are looking for an experienced Engineering Project Manager ...
Quick apply
Engineering Project Manager
Fishers, IN · On-site
We are a dynamic and innovative medical device startup developing a point-of-care portable blood coagulation testing device. Job Summary: We are looking for an experienced Engineering Project Manager ...
Engineering Project Manager
Fishers, IN · On-site
We are a dynamic and innovative medical device startup developing a point-of-care portable blood coagulation testing device. Job Summary: We are looking for an experienced Engineering Project Manager ...
Engineering Project Manager
Fishers, IN · On-site
We are a dynamic and innovative medical device startup developing a point-of-care portable blood coagulation testing device. Job Summary: We are looking for an experienced Engineering Project Manager ...
Stay current with ISO 13485, governmental regulations, medical device standards, and drug-device ... Track and manage project deliverables to ensure timely and quality completion * Adjust schedules ...
Stay current with ISO 13485, governmental regulations, medical device standards, and drug-device ... Track and manage project deliverables to ensure timely and quality completion * Adjust schedules ...
Stay current with ISO 13485, governmental regulations, medical device standards, and drug-device ... Track and manage project deliverables to ensure timely and quality completion * Adjust schedules ...
Quick apply
Stay current with ISO 13485, governmental regulations, medical device standards, and drug-device ... Track and manage project deliverables to ensure timely and quality completion * Adjust schedules ...
Technical Project Manager
Indianapolis, IN · On-site
$85 - $115/hr
Stay current with ISO 13485, governmental regulations, medical device standards, and drug-device ... Track and manage project deliverables to ensure timely and quality completion * Adjust schedules ...
Technical Project Manager
Indianapolis, IN · On-site
$85 - $115/hr
Stay current with ISO 13485, governmental regulations, medical device standards, and drug-device ... Track and manage project deliverables to ensure timely and quality completion * Adjust schedules ...
Provide technical and project-management leadership, set priorities, allocate tasks, mentor team ... Understanding of scientific principles and manufacturing processes used in medical device ...
Provide technical and project-management leadership, set priorities, allocate tasks, mentor team ... Understanding of scientific principles and manufacturing processes used in medical device ...
Medical Device Design Control Engineer
Indianapolis, IN · On-site
$123K - $148K/yr
This role involves supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The engineer will be responsible for reviewing, updating ...
Medical Device Design Control Engineer
Indianapolis, IN · On-site
$123K - $148K/yr
This role involves supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The engineer will be responsible for reviewing, updating ...
About Us: We are a dynamic and innovative medical device startup developing a point-of-care ... Ideal team members thrive under pressure, manage multiple projects, and adapt as company needs ...
Quick apply
About Us: We are a dynamic and innovative medical device startup developing a point-of-care ... Ideal team members thrive under pressure, manage multiple projects, and adapt as company needs ...
About Us: We are a dynamic and innovative medical device startup developing a point-of-care ... Ideal team members thrive under pressure, manage multiple projects, and adapt as company needs ...
About Us: We are a dynamic and innovative medical device startup developing a point-of-care ... Ideal team members thrive under pressure, manage multiple projects, and adapt as company needs ...
Global GxP Quality Project Manager - Pharmaceutical (Hybrid - Indianapolis, IN) Contract
Indianapolis, IN · On-site
Job Summary: The Global GxP Project Manager will support enterprise-level Global Quality ... Drug and medical device experience * Experience supporting inspection readiness or regulatory ...
Global GxP Quality Project Manager - Pharmaceutical (Hybrid - Indianapolis, IN) Contract
Indianapolis, IN · On-site
Job Summary: The Global GxP Project Manager will support enterprise-level Global Quality ... Drug and medical device experience * Experience supporting inspection readiness or regulatory ...
Seasonal Medical Device Project Manager information
What is the difference between Seasonal Medical Device Project Manager vs Medical Device Quality Assurance Specialist?
| Aspect | Seasonal Medical Device Project Manager | Medical Device Quality Assurance Specialist |
|---|---|---|
| Credentials | Project management certification (PMP), relevant industry experience | ISO 13485 training, quality assurance certifications |
| Work Environment | Project teams, manufacturing sites, regulatory agencies | Quality departments, laboratories, compliance offices |
| Employer & Industry Usage | Medical device companies during peak seasons or product launches | Manufacturers ensuring product quality and regulatory compliance |
| Search & Comparison Intent | Understanding project management roles in medical device industry | Quality assurance roles and compliance responsibilities |
The Seasonal Medical Device Project Manager focuses on managing projects during specific seasons or product launches, coordinating teams, and ensuring timely delivery. In contrast, the Medical Device Quality Assurance Specialist concentrates on maintaining product quality, compliance with regulations, and conducting audits. Both roles require industry-specific certifications and work within the medical device manufacturing environment, but their core responsibilities differ significantly.
Full-time
Posted 14 days ago
Job description
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, updating, and maintaining critical documentation such as dFMEA, uFMEA, and Preliminary Hazard Analysis (PHA), ensuring compliance with regulatory and quality standards throughout the product lifecycle.
Key Responsibilities:
- Support and manage Design History File (DHF) activities for medical device projects.
- Review, update, and maintain Global dFMEA and uFMEA documentation, identifying and mitigating risks.
- Develop and update Preliminary Hazard Analysis (PHA) in line with risk management procedures.
- Support the creation and maintenance of product risk management files throughout the development lifecycle.
- Prepare, review, and update Product Characterization documents, Product Specification Documents (PSD), and Critical-to-Quality (CTQ) documents.
- Support the development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
- Ensure robust traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
- Collaborate cross-functionally with Design, Quality, Regulatory, Manufacturing, and Project Management teams.
- Participate in design reviews, providing technical input on risk management and DHF compliance.
- Support engineering change assessments and associated documentation updates.
- Review engineering documents for completeness, accuracy, and compliance with quality system requirements.
- Identify documentation gaps and recommend corrective actions.
- Support audits, inspections, and compliance activities related to design control and risk management documentation.
- Contribute to continuous improvement initiatives for product development and design control processes.
- Ensure all deliverables comply with applicable regulatory, quality, and Zimmer Biomet procedures and standards.
Required Skills:
- Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
- Experience in supporting DHF gap assessments, document linking, metadata management, and compliance reviews.
- Familiarity with digital DHF structure, document hierarchy, and traceability matrix development.
- Knowledge of DHF remediation projects and legacy design documentation migration into Cockpit Cognition.
- Strong written and verbal communication skills for project plans and inter-departmental collaboration.
Qualifications:
- Experience in medical device development environments, particularly with Design History File (DHF) and risk management processes.
About Prophecy Consulting
Sourced by ZipRecruiter
Company size
11 - 50 Employees
Headquarters location
Irvine, CA, US
Year founded
2018