Develop and update Preliminary Hazard Analysis (PHA) in line with risk management procedures ... Experience in medical device development environments, particularly with Design History File (DHF ...
Develop and update Preliminary Hazard Analysis (PHA) in line with risk management procedures ... Experience in medical device development environments, particularly with Design History File (DHF ...
Medical Device Coder
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
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Carmel, IN · On-site
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Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
$18 - $24/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
$18 - $24/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Medical Device Coder
$17.75 - $23.75/hr
Ability to use approved AI tools, including ChatGPT Projects and Custom GPTs, to support medical device coding research, HCPCS data analysis, content validation, audit review, and workflow efficiency.
Support Design History File (DHF) activities for medical device development projects. * Review ... Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk ...
Support Design History File (DHF) activities for medical device development projects. * Review ... Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk ...
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Develop complex data processing software and manage large data analysis. * Develop a user-friendly ... Experience working in the medical device industry. * Familiarity with Agile development ...
Senior Software Engineer for Medical Device Startup
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$115K - $152K/yr
Develop complex data processing software and manage large data analysis. * Develop a user-friendly ... Experience working in the medical device industry. * Familiarity with Agile development ...
Senior Software Engineer for Medical Device Startup
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$115K - $152K/yr
Develop complex data processing software and manage large data analysis. * Develop a user-friendly ... Experience working in the medical device industry. * Familiarity with Agile development ...
Quick apply
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Sr. Medical Writer ICON is a global healthcare intelligence and clinical research organisation ... affairs, to interpret and analyze clinical trial data, summarize scientific findings
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$123K - $148K/yr
Support Design History File (DHF) activities for medical device development projects. * Review ... Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk ...
Medical Device Design Control Engineer
Indianapolis, IN · On-site
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Support Design History File (DHF) activities for medical device development projects. * Review ... Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk ...
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Medical Device Sales Representative - Entry Level
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$50K - $60K/yr
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Medical Device Sales Representative - Entry Level
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Senior Medical Device Analyst information
What is the difference between Senior Medical Device Analyst vs Medical Device Analyst?
| Aspect | Senior Medical Device Analyst | Medical Device Analyst |
|---|---|---|
| Required Credentials | Bachelor's degree, experience in medical device industry, possibly certifications | Bachelor's degree, entry-level experience |
| Work Environment | Regulatory agencies, medical device companies, R&D labs | Manufacturers, quality assurance, regulatory teams |
| Employer & Industry Usage | Used in larger organizations for advanced roles | Entry to mid-level roles across the industry |
| Common Search & Comparison | Often compared for career progression | Base role for medical device industry professionals |
The main difference between a Senior Medical Device Analyst and a Medical Device Analyst lies in experience and responsibilities. Senior analysts typically have more industry experience, handle complex projects, and may oversee junior staff. Both roles require relevant credentials and work within similar environments, but the senior position indicates a higher level of expertise and leadership within the medical device industry.
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Full-time
Posted 12 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