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Research And Development Engineer Medical Device Jobs in Ohio

PB consulting

OH

We are seeking a Medical Device Component Development Engineer to support component development, product lifecycle management, and engineering change activities for regulated medical devices. The ...

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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 are the key skills and qualifications needed to thrive as a research and development engineer in the medical device industry?

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.

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 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 popular job titles related to Research And Development Engineer Medical Device jobs in Ohio?

For Research And Development Engineer Medical Device jobs in Ohio, the most frequently searched job titles are:

What job categories do people searching Research And Development Engineer Medical Device jobs in Ohio look for?

The top searched job categories for Research And Development Engineer Medical Device jobs in Ohio are:

What cities in Ohio are hiring for Research And Development Engineer Medical Device jobs?

Cities in Ohio with the most Research And Development Engineer Medical Device job openings:

Research And Development Engineer Medical Device jobs near you
Infographic showing various Research And Development Engineer Medical Device job openings in Ohio as of August 2026, with employment types broken down into 1% As Needed, 76% Full Time, 16% Part Time, 1% Temporary, 5% Contract, and 1% Nights. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution.

Medical Device Component Development Engineer

West Chester, OH

PB consulting
See more jobs at PB consultingexternal

Full-time

Posted 15 days ago

Job description

We are seeking a Medical Device Component Development Engineer to support component development, product lifecycle management, and engineering change activities for regulated medical devices. The ideal candidate will have expertise in design controls, verification & validation, supplier quality, process validation, and regulatory compliance.

Roles and Responsibilities
  • Lead component development and engineering change projects from concept to implementation.
  • Manage project timelines, risks, and cross-functional coordination.
  • Support Design Verification & Validation (V&V), test protocols, and technical documentation.
  • Partner with suppliers on component qualification, DFM reviews, tooling, and process capability.
  • Support manufacturing transfer, IQ/OQ/PQ, pilot builds, and production readiness.
  • Apply Design Controls, PLM, ECO/ECN/ECR, Risk Management, and Quality System requirements.
  • Review engineering drawings, GD&T, specifications, and acceptance criteria.
  • Drive root cause analysis using CAPA, 8D, 5 Whys, and Fishbone methodologies.
  • Communicate project status, risks, and technical recommendations to stakeholders.
Required Qualifications
  • Experience in Medical Device Component Development or Product Development.
  • Strong knowledge of:
    • Product Lifecycle Management (PLM)
    • Design Controls & Engineering Change Management (ECO/ECN/ECR)
    • Design Verification & Validation (V&V)
    • ISO 14971, DFMEA, PFMEA
    • ISO 13485 & FDA 21 CFR Part 820/QMSR
    • Supplier Quality Engineering & Design for Manufacturability (DFM)
    • Process Validation (IQ/OQ/PQ)
    • GD&T and engineering drawings
  • Strong project management, communication, and problem-solving skills.
  • Experience working with cross-functional teams in a regulated medical device environment.
Preferred Skills
  • Medical Device Product Development
  • Supplier Quality & Component Qualification
  • Risk Management & Regulatory Compliance
  • Manufacturing Transfer & Validation
  • Root Cause Analysis (CAPA, 8D)
  • Stakeholder & Project Management

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