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Freelance Medical Device Product Development Jobs

OH · On-site

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 ...

Product Development Engineer III

Saint Paul, MN · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

At Forj Medical, we work side by side with more than 100 medical device companies from startups to ... Product Development Engineer III applies advanced engineering principles and medical device product ...

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Medical Device Component Development Engineer

PB consulting

Loveland, OH • On-site

Full-time

This job post has expired today. Applications are no longer accepted.


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