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Medical Device Manufacturing Engineer Jobs in Ohio

PB consulting

We are seeking a Medical Device Component Development Engineer to support component development ... Support manufacturing transfer, IQ/OQ/PQ, pilot builds, and production readiness. * Apply Design ...

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Medical Device Manufacturing Engineer information

See Ohio salary details

$45.2K

$81.4K

$114.1K

How much do medical device manufacturing engineer jobs pay per year?

As of Aug 23, 2026, the average yearly pay for medical device manufacturing engineer in Ohio is $81,392.00, according to ZipRecruiter salary data. Most workers in this role earn between $69,400.00 and $89,400.00 per year, depending on experience, location, and employer.

What does a medical device manufacturing engineer do?

A Medical Device Manufacturing Engineer is responsible for designing, developing, and optimizing manufacturing processes for medical devices. They ensure that products are produced efficiently, safely, and in compliance with regulatory standards such as FDA or ISO guidelines. Their work involves collaborating with design teams, troubleshooting production issues, implementing quality control procedures, and continuously improving manufacturing methods to enhance product quality. Ultimately, they play a key role in bringing safe and effective medical devices to market.

What are the key skills and qualifications needed to thrive as a medical device manufacturing engineer?

To excel as a Medical Device Manufacturing Engineer, you need a solid background in engineering principles, manufacturing processes, and regulatory compliance, typically supported by a degree in biomedical, mechanical, or industrial engineering. Familiarity with CAD software, Six Sigma/Lean methodologies, and knowledge of FDA or ISO 13485 standards is essential. Strong problem-solving, teamwork, and communication skills help manage cross-functional projects and ensure product quality. These competencies are crucial for developing safe, effective devices in a highly regulated industry where precision and compliance are paramount.

What are some common challenges faced by medical device manufacturing engineers during product development?

Medical Device Manufacturing Engineers often encounter challenges in balancing strict regulatory compliance with efficient production processes. Adapting to frequent design changes, ensuring high product quality, and validating manufacturing processes are crucial tasks. Additionally, they collaborate closely with cross-functional teams—including quality assurance, R&D, and supply chain—to troubleshoot production issues and implement improvements. Addressing these challenges requires strong problem-solving skills and a keen attention to detail.

What is the difference between Medical Device Manufacturing Engineer vs Quality Assurance Engineer?

AspectMedical Device Manufacturing EngineerQuality Assurance Engineer
CredentialsBachelor's in engineering or related field; certifications like ASQ CQE beneficialBachelor's in engineering, quality assurance, or related; certifications like ASQ CQE or CQA common
Work EnvironmentManufacturing plants, production lines, R&D labsQuality labs, manufacturing sites, regulatory agencies
Industry UsageDesign, develop, and optimize manufacturing processesEnsure product quality, compliance, and process improvements

While both roles work within the medical device industry and require similar credentials, the Medical Device Manufacturing Engineer focuses on manufacturing processes and product development, whereas the Quality Assurance Engineer emphasizes maintaining quality standards and regulatory compliance.

What are popular job titles related to Medical Device Manufacturing Engineer jobs in Ohio?

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

What job categories do people searching Medical Device Manufacturing Engineer jobs in Ohio look for?

The top searched job categories for Medical Device Manufacturing Engineer jobs in Ohio are:

Medical Device Manufacturing Engineer jobs near you
Infographic showing various Medical Device Manufacturing Engineer job openings in Ohio as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 12% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $81,392 per year, or $39.1 per hour.

Medical Device Component Development Engineer

PB consulting

Cincinnati, OH • On-site

Full-time

Posted 10 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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