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Manager Medical Device Operations Jobs in Indiana

Flotec

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Machinist / Inspector - Medical Device Manufacturing

Avon, IN · On-site

$40K - $55K/yr

Machinist / Inspector - Medical Device Manufacturing Company Overview Flotec is an Indianapolis ... Flotec is classified as a "Healthcare & Public Health Operation" and is EXEMPT from the Stay at ...

Flotec

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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 ... Flotec is classified as a "Healthcare & Public Health Operation" and is EXEMPT from the Stay at ...

TGG Accounting

Medical Device Controller

Plainfield, IN

$108K - $130K/yr

Manage cash flow and help transition the organization from receivables-based financing toward ... ownership, operations, engineering, sales, purchasing, outside advisors, and investors. * A ...

New

TGG Accounting

Medical Device Controller

Plainfield, IN · On-site

$125K - $150K/yr

Manage cash flow and help transition the organization from receivables-based financing toward ... ownership, operations, engineering, sales, purchasing, outside advisors, and investors. * A ...

New

TGG Accounting

Medical Device Controller

Plainfield, IN · On-site

$108K - $130K/yr

Manage cash flow and help transition the organization from receivables-based financing toward ... ownership, operations, engineering, sales, purchasing, outside advisors, and investors. * A ...

New

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Manager Medical Device Operations information

What is a manager medical device operations?

A Manager Medical Device Operations oversees the daily activities and processes involved in manufacturing, distributing, and maintaining medical devices. They ensure that operations comply with regulatory standards, manage teams, and work to optimize efficiency, quality, and safety. This role often involves coordinating with other departments, handling audits, and implementing process improvements to meet organizational goals. They play a critical role in ensuring that medical devices reach healthcare providers and patients safely and on time.

What are the key skills and qualifications needed to thrive as a manager medical device operations?

To excel as a Manager Medical Device Operations, you need expertise in supply chain management, regulatory compliance (such as FDA and ISO standards), and operational leadership, typically supported by a bachelor’s degree in engineering, life sciences, or business. Familiarity with ERP systems, quality management software, and relevant certifications like Six Sigma or PMP are commonly required. Strong communication, problem-solving, and team leadership skills help drive cross-functional collaboration and continuous improvement. These competencies are essential for ensuring product quality, regulatory adherence, and efficient operations in a highly regulated industry.

What are some common challenges faced by a manager medical device operations, and how can they be addressed?

Managers in Medical Device Operations often face challenges such as ensuring compliance with strict regulatory standards, coordinating cross-functional teams, and managing supply chain complexities. Staying proactive with regulatory updates, fostering open communication among departments, and implementing robust quality management systems can help address these issues. Additionally, investing in staff training and process improvement initiatives can streamline operations and minimize delays or compliance risks.

What are popular job titles related to Manager Medical Device Operations jobs in Indiana?

For Manager Medical Device Operations jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Manager Medical Device Operations jobs in Indiana look for?

The top searched job categories for Manager Medical Device Operations jobs in Indiana are:

What cities in Indiana are hiring for Manager Medical Device Operations jobs?

Cities in Indiana with the most Manager Medical Device Operations job openings:

Manager Medical Device Operations jobs near you
Infographic showing various Manager Medical Device Operations job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, and 5% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution.

Medical Device DHF Engineer

Prophecy Technologies

Indianapolis, IN • On-site

Full-time

Re-posted 8 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