Support and manage Design History File (DHF) activities for medical device projects. * Review ... Review engineering documents for completeness, accuracy, and compliance with quality system ...
Support and manage Design History File (DHF) activities for medical device projects. * Review ... Review engineering documents for completeness, accuracy, and compliance with quality system ...
Quality Engineer Medical Device
Roseville, MN · On-site
$100K - $115K/yr
... Engineer in a regulated industry, preferably medical devices. * Experience with FDA regulations, ISO 13485, and other medical device quality standards. * Proficiency in quality tools and ...
Quick apply
Quality Engineer Medical Device
Roseville, MN · On-site
$100K - $115K/yr
... Engineer in a regulated industry, preferably medical devices. * Experience with FDA regulations, ISO 13485, and other medical device quality standards. * Proficiency in quality tools and ...
Medical device engineer
North Chicago, IL · On-site
... days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance ... Evaluate and integrate relevant engineering advances for improving or solving problems Understand ...
Medical device engineer
North Chicago, IL · On-site
... days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance ... Evaluate and integrate relevant engineering advances for improving or solving problems Understand ...
Service Engineer I -- Medical Device Repair amp; Support STORZ MEDICAL America | Kennesaw, GA | On-site, minimal travel | $52,000-$60,000 annually About the Role STORZ MEDICAL America is the U.S ...
Service Engineer I -- Medical Device Repair amp; Support STORZ MEDICAL America | Kennesaw, GA | On-site, minimal travel | $52,000-$60,000 annually About the Role STORZ MEDICAL America is the U.S ...
This role focuses on supporting Design History File (DHF) activities for medical device development projects, ensuring compliance with regulatory and quality system requirements. The engineer will be ...
This role focuses on supporting Design History File (DHF) activities for medical device development projects, ensuring compliance with regulatory and quality system requirements. The engineer will be ...
Quality Engineer Medical Device
Roseville, MN · On-site
$100K - $115K/yr
... Engineer in a regulated industry, preferably medical devices. * Experience with FDA regulations, ISO 13485, and other medical device quality standards. * Proficiency in quality tools and ...
Quick apply
Quality Engineer Medical Device
Roseville, MN · On-site
$100K - $115K/yr
... Engineer in a regulated industry, preferably medical devices. * Experience with FDA regulations, ISO 13485, and other medical device quality standards. * Proficiency in quality tools and ...
Medical Device Assembler
Westford, MA · On-site
$19 - $21.51/hr
Medical Device Assembler Location : Westford, MA Employment Type : Full-Time| 6 Month contract | W2 ... tier consulting and staffing solutions across industries like technology, engineering ...
Medical Device Assembler
Westford, MA · On-site
$19 - $21.51/hr
Medical Device Assembler Location : Westford, MA Employment Type : Full-Time| 6 Month contract | W2 ... tier consulting and staffing solutions across industries like technology, engineering ...
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Medical Device Assembler
Westford, MA · On-site
$19 - $21.50/hr
Medical Device Assembler Location : Westford, MA Employment Type : Full-Time| 6 Month contract | W2 ... tier consulting and staffing solutions across industries like technology, engineering ...
Quick apply
Be Seen First
Medical Device Assembler
Westford, MA · On-site
$19 - $21.50/hr
Medical Device Assembler Location : Westford, MA Employment Type : Full-Time| 6 Month contract | W2 ... tier consulting and staffing solutions across industries like technology, engineering ...
Medical Device Test Engineer
Waukesha, WI · On-site
As a Medical Device Test Engineer, you will be part of the Quality Assurance department supporting ... Supportive team dedicated to innovation and quality Upon completion of waiting period consultants ...
Medical Device Test Engineer
Waukesha, WI · On-site
As a Medical Device Test Engineer, you will be part of the Quality Assurance department supporting ... Supportive team dedicated to innovation and quality Upon completion of waiting period consultants ...
Manufacturing Engineer - Medical Device (Process
Irvine, CA · On-site
$78K - $105K/yr
Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting ... Our client, a medical device manufacturer, is seeking a Manufacturing Engineer to support ...
Quick apply
Manufacturing Engineer - Medical Device (Process
Irvine, CA · On-site
$78K - $105K/yr
Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting ... Our client, a medical device manufacturer, is seeking a Manufacturing Engineer to support ...
Medical Device Assembler
Santa Rosa, CA · On-site
$22 - $24/hr
Pay Rate Low: 22 | Pay Rate High: 24 A medical device manufacturer is seeking a Production/Assembly ... Collaborate with supervisors, engineers, and technicians to resolve line issues and suggest ...
Medical Device Assembler
Santa Rosa, CA · On-site
$22 - $24/hr
Pay Rate Low: 22 | Pay Rate High: 24 A medical device manufacturer is seeking a Production/Assembly ... Collaborate with supervisors, engineers, and technicians to resolve line issues and suggest ...
Senior Medical Device Engineer
Blue Ash, OH · On-site
$96K - $131K/yr
Senior Medical Device Lifecycle Engineer Location: Blue Ash, OH Duration: 6 Months Contract We are seeking an experienced Senior Medical Device Lifecycle Engineer to lead product lifecycle and ...
Senior Medical Device Engineer
Blue Ash, OH · On-site
$96K - $131K/yr
Senior Medical Device Lifecycle Engineer Location: Blue Ash, OH Duration: 6 Months Contract We are seeking an experienced Senior Medical Device Lifecycle Engineer to lead product lifecycle and ...
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Medical Device Assembler - 30537_M
Scottsdale, AZ · On-site
$17 - $19/hr
Medical Device Assembler Location: Scottsdale, AZ (85255) Employment Type: 12-month Contract ... tier consulting and staffing solutions across industries like technology, engineering ...
Quick apply
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Medical Device Assembler - 30537_M
Scottsdale, AZ · On-site
$17 - $19/hr
Medical Device Assembler Location: Scottsdale, AZ (85255) Employment Type: 12-month Contract ... tier consulting and staffing solutions across industries like technology, engineering ...
Medical Device Controls Engineer
Maple Grove, MN · On-site
$85K - $110K/yr
Medical Device Controls Engineer Client: Medical Device Industry Duration: 12 Months Contract Location: Maple Grove, MN 55311 Medical Device Controls Engineer About This Role: This is an opportunity ...
Medical Device Controls Engineer
Maple Grove, MN · On-site
$85K - $110K/yr
Medical Device Controls Engineer Client: Medical Device Industry Duration: 12 Months Contract Location: Maple Grove, MN 55311 Medical Device Controls Engineer About This Role: This is an opportunity ...
Working remotely you will have direct interface with medical device engineering and purchasing ... personnel to identify opportunities for our key principle products and technologies. This will ...
Working remotely you will have direct interface with medical device engineering and purchasing ... personnel to identify opportunities for our key principle products and technologies. This will ...
Working remotely you will have direct interface with medical device engineering and purchasing ... personnel to identify opportunities for our key principle products and technologies. This will ...
Working remotely you will have direct interface with medical device engineering and purchasing ... personnel to identify opportunities for our key principle products and technologies. This will ...
Medical Device Assembler - 30471
Scarborough, ME · On-site
$26 - $28.06/hr
Medical Device Assembler Location: Scarborough, ME 04074 Employment Type: W2 Contract - 3 Months ... tier consulting and staffing solutions across industries like technology, engineering ...
Medical Device Assembler - 30471
Scarborough, ME · On-site
$26 - $28.06/hr
Medical Device Assembler Location: Scarborough, ME 04074 Employment Type: W2 Contract - 3 Months ... tier consulting and staffing solutions across industries like technology, engineering ...
Be Seen First
Medical Device Assembler - 30471
Scarborough, ME · On-site
$26 - $28/hr
Medical Device Assembler Location: Scarborough, ME 04074 Employment Type: W2 Contract - 3 Months ... tier consulting and staffing solutions across industries like technology, engineering ...
Quick apply
Be Seen First
Medical Device Assembler - 30471
Scarborough, ME · On-site
$26 - $28/hr
Medical Device Assembler Location: Scarborough, ME 04074 Employment Type: W2 Contract - 3 Months ... tier consulting and staffing solutions across industries like technology, engineering ...
Medical Device Design Quality Engineer
Pittsburgh, PA · On-site
$37 - $42/hr
As a Medical Device Design Quality Engineer, you will be part of the Quality Assurance department ... Upon completion of waiting period consultants are eligible for: * Medical and Prescription Drug ...
Medical Device Design Quality Engineer
Pittsburgh, PA · On-site
$37 - $42/hr
As a Medical Device Design Quality Engineer, you will be part of the Quality Assurance department ... Upon completion of waiting period consultants are eligible for: * Medical and Prescription Drug ...
AAC Consultant
Hattiesburg, MS · On-site
Cook Medical Supply is looking for highly motivated individuals who want to be a part of our growing team!! We are currently seeking Full-time Speech Device Consultants to market AAC (Augmentative ...
Quick apply
AAC Consultant
Hattiesburg, MS · On-site
Cook Medical Supply is looking for highly motivated individuals who want to be a part of our growing team!! We are currently seeking Full-time Speech Device Consultants to market AAC (Augmentative ...
Medical Device Consultant Engineer information
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Medical Device DHF Engineer
Indianapolis, IN • On-site
Full-time
Re-posted 15 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
Industry
Professional, scientific, and technical services
Company size
11 - 50 Employees
Headquarters location
Irvine, CA, US