Support the creation and maintenance of product risk management files throughout the development ... Experience in medical device development environments, particularly with Design History File (DHF ...
Support the creation and maintenance of product risk management files throughout the development ... Experience in medical device development environments, particularly with Design History File (DHF ...
Medical Device Assembler
Carmel, IN · On-site
$20 - $23/hr
Medical
Dental
Vision
Life
Retirement
Accurately complete paper and electronic documentation to maintain full product traceability and ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...
Medical Device Assembler
Carmel, IN · On-site
$20 - $23/hr
Medical
Dental
Vision
Life
Retirement
Accurately complete paper and electronic documentation to maintain full product traceability and ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...
Medical Device Coder
Carmel, IN · On-site
$18.50 - $24.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$18.50 - $24.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Indianapolis, IN · On-site
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
New
Medical Device Coder
Indianapolis, IN · On-site
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
New
Medical Device Coder
Indianapolis, IN · On-site
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
New
Medical Device Coder
Indianapolis, IN · On-site
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
New
Medical Device Coder
Indianapolis, IN · On-site
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
New
Medical Device Coder
Indianapolis, IN · On-site
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
New
Medical Device Coder
Indianapolis, IN · On-site
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Indianapolis, IN · On-site
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$18.50 - $24.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$18.50 - $24.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
$18 - $24/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
Medical Device Coder
Carmel, IN · On-site
$17.75 - $23.75/hr
Medical
Dental
Vision
Life
Retirement
PTO
Productive. Committed. Willing and able to go above and beyond. Passionate about making a ... Previous experience in supply chain management or medical device industry preferred. * Certified ...
The engineer will be responsible for managing risk documentation, product specifications, and ... Support Design History File (DHF) activities for medical device development projects. * Review ...
The engineer will be responsible for managing risk documentation, product specifications, and ... Support Design History File (DHF) activities for medical device development projects. * Review ...
Medical Device Sales Rep
Fort Wayne, IN · On-site
... the medical device industry. Our client is a rapidly growing organization that provides an FDA ... product that truly improves patient outcomes while joining a company with tremendous growth ...
Quick apply
Medical Device Sales Rep
Fort Wayne, IN · On-site
... the medical device industry. Our client is a rapidly growing organization that provides an FDA ... product that truly improves patient outcomes while joining a company with tremendous growth ...
Machinist / Inspector - Medical Device Manufacturing
Avon, IN · On-site
$40K - $55K/yr
Medical
Dental
Vision
Machinist / Inspector - Medical Device Manufacturing Company Overview Flotec is an Indianapolis ... We manufacture precision medical products including oxygen regulators, flowmeters, fittings, valves ...
Quick apply
Machinist / Inspector - Medical Device Manufacturing
Avon, IN · On-site
$40K - $55K/yr
Medical
Dental
Vision
Machinist / Inspector - Medical Device Manufacturing Company Overview Flotec is an Indianapolis ... We manufacture precision medical products including oxygen regulators, flowmeters, fittings, valves ...
Medical Device Design Control Engineer
Indianapolis, IN · On-site
$123K - $148K/yr
Support Design History File (DHF) activities for medical device development projects. * Review ... Support creation and maintenance of product risk management files throughout the development ...
Medical Device Design Control Engineer
Indianapolis, IN · On-site
$123K - $148K/yr
Support Design History File (DHF) activities for medical device development projects. * Review ... Support creation and maintenance of product risk management files throughout the development ...
Product Manager Medical Device information
See Indiana salary details
$59.24 - $60.47
7% of jobs
$60.47 - $61.70
11% of jobs
$62.77 is the 25th percentile. Wages below this are outliers.
$61.70 - $62.92
9% of jobs
$62.92 - $64.15
9% of jobs
$64.15 - $65.38
9% of jobs
The median wage is $66.11 / hr.
$65.38 - $66.61
11% of jobs
$66.61 - $67.83
9% of jobs
$67.83 - $69.06
9% of jobs
$69.52 is the 75th percentile. Wages above this are outliers.
$69.06 - $70.29
9% of jobs
$70.29 - $71.51
11% of jobs
$71.51 - $72.74
9% of jobs
$59
$66
$72
How much do product manager medical device jobs pay per hour?
What are some common challenges faced by product managers in the medical device industry, and how can they be addressed?
What does a product manager do in the medical device industry?
The job duties of a medical device product manager may include managing the technical aspects of product design and development, and defining the target market that the product serves. Your responsibilities in this role may consist of planning the process that the company uses to develop a medical device. This process may include obtaining relevant documentation and approval from medical regulatory bodies. Some medical device product managers focus on marketing products by developing a marketing strategy, defining a target market, and coming up with a pricing strategy.
What are the key skills and qualifications needed to thrive as a product manager in medical devices, and why are they important?
What is the difference between Product Manager Medical Device vs Regulatory Affairs Specialist in the medical device industry?
| Aspect | Product Manager Medical Device | Regulatory Affairs Specialist |
|---|---|---|
| Required Credentials | Bachelor's degree, experience in product management, knowledge of medical devices | Bachelor's degree, certification in regulatory affairs, knowledge of FDA regulations |
| Work Environment | Cross-functional teams, product development, marketing | Regulatory compliance, documentation, liaising with authorities |
| Employer & Industry Usage | Medical device companies, healthcare firms | Medical device manufacturers, regulatory agencies |
| Common Search & Comparison Intent | Understanding roles in product development | Understanding regulatory responsibilities |
The Product Manager Medical Device focuses on developing, launching, and managing medical device products, ensuring market success. In contrast, the Regulatory Affairs Specialist ensures products meet regulatory standards and obtain necessary approvals. Both roles are essential in the medical device industry but serve different functions within the product lifecycle.
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- Director Orthopedic Device Sales
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- Diabetes Territory Manager
- Contract Medical Device Design
- Orthopedic Device Sales
- Internship Orthopedic Device Sales

Full-time
Posted 17 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