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Research And Development Engineer Medical Device Jobs in Indiana

... R&D experience. * Experience participating in product development projects from concept through ... Experience in the medical device, healthcare, consumer products, or other regulated industry.

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Read and interpret engineering drawings, work instructions, inspection plans, routings, and manufacturing documentation. * Verify dimensional accuracy, surface finish, threads, features, and critical ...

The Development Engineer supports the Project Core Team over the course of a project, performing ... Candidates with medical device industry experience are strongly preferred, especially those with ...

R&D Formulation Scientist

Columbus, IN ยท On-site

$27 - $30/hr

Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to support product development ... cosmetics, medical device, or consumer products industries. * Familiarity with GLP, GMP, USP ...

Manufacturing Engineer

Warsaw, IN ยท On-site

$70K - $90K/yr

Role : Medical Device Manufacturing Engineer Location: Warsaw, IN Duration: 6+ months Experience Required 4 - 6 years (Prior Zimmer Biomet experience is preferred) Technical/Functional Skills:

Showing results 21-40

Research And Development Engineer Medical Device information

What does a Research and Development Engineer do in the medical device industry?

A Research and Development (R&D) Engineer in the medical device industry is responsible for designing, developing, and testing new medical devices and technologies. They work closely with cross-functional teams to ensure products meet regulatory standards, are safe for patient use, and address clinical needs. Their tasks may include prototyping, conducting experiments, analyzing data, and collaborating with manufacturing teams to bring products from concept to market. R&D Engineers also stay updated on technological advancements and regulatory changes to ensure innovation and compliance.

What is the difference between Research And Development Engineer Medical Device vs Quality Assurance Engineer Medical Device?

AspectResearch And Development Engineer Medical DeviceQuality Assurance Engineer Medical Device
Primary FocusDesigning, developing, and testing new medical device productsEnsuring products meet quality standards and regulatory requirements
Required CredentialsEngineering degree, knowledge of product developmentEngineering or science degree, knowledge of quality systems
Work EnvironmentResearch labs, product development teamsManufacturing facilities, quality control departments
Industry UsageInvolved in innovation and product creationInvolved in compliance, validation, and process improvement

While both roles require engineering knowledge and are integral to the medical device industry, Research And Development Engineers focus on creating and testing new products, whereas Quality Assurance Engineers ensure these products meet safety and quality standards throughout production.

What are some common challenges faced by Research and Development Engineers in the medical device industry?

Research and Development Engineers in the medical device industry often face challenges such as navigating complex regulatory requirements, managing tight project timelines while ensuring product safety and efficacy, and collaborating with cross-functional teams like quality assurance and clinical affairs. Additionally, adapting to rapid technological advancements and integrating feedback from clinicians and end-users into the design process can be demanding. These challenges require strong problem-solving skills, adaptability, and effective communication to deliver innovative and compliant medical devices.

What are the key skills and qualifications needed to thrive as a Research and Development Engineer in Medical Devices, and why are they important?

To excel as a Research and Development Engineer in Medical Devices, you need a solid background in biomedical engineering or a related field, strong problem-solving skills, and experience with product development cycles. Familiarity with CAD software, prototyping tools, regulatory standards like ISO 13485, and relevant certifications (such as Six Sigma) is highly valued. Excellent teamwork, creativity, and effective communication are crucial soft skills for collaborating across multidisciplinary teams and driving innovation. These competencies ensure the design and launch of safe, effective, and compliant medical devices that improve patient outcomes.
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Infographic showing various Research And Development Engineer Medical Device job openings in Indiana as of July 2026, with employment types broken down into 1% As Needed, 76% Full Time, 17% Part Time, and 6% Contract. Highlights an 93% Physical, 1% Hybrid, and 6% Remote job distribution.

Medical Device Design Control Engineer

Prophecy Technologies

Indianapolis, IN โ€ข On-site

$123K - $148K/yr

Full-time

Posted 7 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