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Seasonal Medical Device Project Manager Jobs in Indiana

ATR International

Medical Device Assembler

Westfield, IN · On-site

$21.50 - $23/hr

The ability to communicate effectively, manage small components, and prioritize work efficiently is essential. No travel is required, and day or evening shifts are typical. On-the-job training is ...

Hearst Health

Medical Device Coder

Carmel, IN · On-site

$18.50 - $24.75/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 ...

First Databank

Medical Device Coder

Indianapolis, IN · On-site

$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 ...

Hearst

Medical Device Coder

Carmel, IN · On-site

$18.50 - $24.75/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 ...

Levisonics Inc

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 ...

Flotec

Be Seen First

Customer Service Advocate - Medical Device Manufacturing

Avon, IN · On-site

$40K - $60K/yr

Coordinate with production, quality, shipping, purchasing, and management to support customer needs ... Experience in medical device, healthcare, manufacturing, distribution, or regulated industries.

Compass Group

CAPITAL PROJECT MANAGER

Mount Vernon, IN · On-site

$100K - $150K/yr

... medical device, chemical, or other regulated manufacturing environments. * Demonstrated experience managing projects involving facility expansion, manufacturing equipment, process systems, utilities ...

Compass Group

CAPITAL PROJECT MANAGER

Mount Vernon, IN

$100K - $150K/yr

... medical device, chemical, or other regulated manufacturing environments. * Demonstrated experience managing projects involving facility expansion, manufacturing equipment, process systems, utilities ...

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All JobsMedical Device Project JobsSeasonal Medical Device Project Manager JobsSeasonal Medical Device Project Manager Jobs in Indiana

Seasonal Medical Device Project Manager information

What is the difference between Seasonal Medical Device Project Manager vs Medical Device Quality Assurance Specialist?

AspectSeasonal Medical Device Project ManagerMedical Device Quality Assurance Specialist
CredentialsProject management certification (PMP), relevant industry experienceISO 13485 training, quality assurance certifications
Work EnvironmentProject teams, manufacturing sites, regulatory agenciesQuality departments, laboratories, compliance offices
Employer & Industry UsageMedical device companies during peak seasons or product launchesManufacturers ensuring product quality and regulatory compliance
Search & Comparison IntentUnderstanding project management roles in medical device industryQuality 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.

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Seasonal Medical Device Project Manager jobs near you

Medical Device DHF Engineer

Prophecy Technologies

Indianapolis, IN • On-site

Full-time

Re-posted 5 days ago

Job description

Role Overview:
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.

Apply