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Director Engineering Medical Device Jobs in Indiana

Flotec

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Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical field preferred. * Experience in medical device manufacturing or another regulated manufacturing environment.

Imh

Python Programing Experience * Quality Assurance and Risk Analysis. * Medical Device design ... Highly self-motivated and directed with high level of attention to detail. Physical Requirements

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Showing results 21-40

All JobsEngineering Medical Device JobsDirector Engineering Medical Device JobsDirector Engineering Medical Device Jobs in Indiana

Director Engineering Medical Device information

See Indiana salary details

$69.5K

$185.3K

$241.7K

How much do director engineering medical device jobs pay per year?

As of Aug 23, 2026, the average yearly pay for director engineering medical device in Indiana is $185,278.00, according to ZipRecruiter salary data. Most workers in this role earn between $134,600.00 and $240,700.00 per year, depending on experience, location, and employer.

What is a director engineering medical device?

A Director of Engineering in the medical device industry leads the design, development, and testing of medical technologies while ensuring compliance with regulatory standards. They manage engineering teams, oversee project timelines, and collaborate with cross-functional departments, including R&D, quality assurance, and manufacturing. Their role involves strategic planning, resource allocation, and risk management to drive innovation and bring safe, effective medical devices to market.

What are the key skills and qualifications needed to thrive in the director engineering medical device position?

To excel as a Director Engineering Medical Device, you need extensive experience in engineering management, regulatory compliance (such as FDA and ISO standards), and a background in medical device design or related technical fields. Proficiency with product lifecycle management (PLM) tools, design control systems, and quality management certifications like Six Sigma or PMP are highly valuable. Outstanding leadership, strategic thinking, and the ability to communicate effectively across multidisciplinary teams help set top performers apart. These capabilities are crucial to successfully guide high-stakes projects, ensure regulatory compliance, and drive innovation in a highly regulated industry.

What are the typical challenges faced by a director of engineering in the medical device industry?

A Director of Engineering in the medical device field often navigates complex regulatory requirements while balancing innovation and speed-to-market. They frequently manage cross-functional teams, oversee rigorous testing and verification processes, and must ensure that all products meet strict quality and safety standards. Collaboration with regulatory, clinical, and marketing teams is essential to align technical development with business objectives. Additionally, adapting to evolving technology and changes in regulatory landscapes can present ongoing challenges, making strong leadership and adaptability key assets.

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What job categories do people searching Director Engineering Medical Device jobs in Indiana look for?

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What cities in Indiana are hiring for Director Engineering Medical Device jobs?

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Director Engineering Medical Device jobs near you
Infographic showing various Director Engineering Medical Device job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 16% Part Time, and 6% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $185,278 per year, or $89.1 per hour.

Medical Device Design Control Engineer

Prophecy Technologies

Indianapolis, IN • On-site

$123K - $148K/yr

Full-time

Posted 27 days ago

Job description

Role Overview:
This role involves supporting Design History File (DHF) activities and comprehensive risk management for medical device development projects. The engineer will be responsible for reviewing, updating, and maintaining critical documentation such as FMEAs, PHAs, Product Characterization, and Product Specifications, ensuring compliance with regulatory and quality standards throughout the product lifecycle.
Key Responsibilities:
  • Support Design History File (DHF) activities for medical device development projects.
  • Review, update, and maintain Global dFMEA documentation ensuring risks are adequately identified, analyzed, and mitigated.
  • Review, update, and maintain Global uFMEA documentation based on product use scenarios and user-related risks.
  • Develop and update Preliminary Hazard Analysis (PHA) documentation in accordance with risk management procedures.
  • Support creation and maintenance of product risk management files throughout the development lifecycle.
  • Prepare, review, and update Product Characterization documents to define product performance and design intent.
  • Create and maintain Product Specification Documents (PSD) ensuring alignment with design requirements and customer needs.
  • Develop and update Critical-to-Quality (CTQ) documents and establish measurable quality requirements.
  • Support development and maintenance of Design Input, Design Output, Verification, and Validation documentation.
  • Ensure traceability between user needs, design inputs, risk controls, verification activities, and design outputs.
  • Collaborate with Design, Quality, Regulatory, Manufacturing, and Project Management teams to support product development deliverables.
  • Participate in design reviews and provide 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 gaps in documentation 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.
  • Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.

Required Skills:
  • Ability to establish document traceability between User Needs, Design Inputs, Design Outputs, Risk Management, Verification, and Validation records within Cockpit Cognition.
  • Experience 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.

Qualifications:
  • Experience: N/A

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