Medical Device Component Development Engineer Job at PB consulting, Blue Ash, OH

YnpuS1ZDY3Q0T0puL1Y4RitMVDI3emdzVlE9PQ==
  • PB consulting
  • Blue Ash, OH

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

Job Tags

Full time

Similar Jobs

VetsEZ

Business Analyst (Remote Opportunity) Job at VetsEZ

 ...We are currently looking for a Business Analyst for a 100% remote position supporting a large federal government healthcare modernization project. The Business Analyst will drive the technical and functional integration of the Payment Integrity Validation and Oversight... 

Grandma's Coffee House

Barista/Cashier/Food Runner/Dishwasher/Prep/Stock/Baker Job at Grandma's Coffee House

**Job Title: Barista/Cashier/Food Runner/Dishwasher/Prep/Stock/Baker****Location:** Grandma's Coffee House **Job Type:** Part-Time...  ...or equivalent preferred. - Previous experience in a caf or restaurant setting is a plus. - Strong customer service skills and a passion... 

Amrecco

Urgent Customs Broker — JFK area (Mandarin speaking) Job at Amrecco

One of the large Asia/US eCommerce logistics companies is looking for a detail-oriented Licensed Customs Broker to support cross-border operations in the JFK / New York area . This role focuses on monitoring inbound/outbound shipments, preparing customs documentation...

Carenest Health Services

Registered Nurse - Interventional Radiology Job at Carenest Health Services

 ...Requirements: Active Ohio RN License (Required) BLS (Required) ACLS (Required) Minimum 2 years of experience Interventional Radiology experience required EPIC experience preferred Call Requirements: 2 shifts of call during contract Schedule Notes: Every other or every... 

Schlumberger

Reservoir Engineer Job at Schlumberger

 ...the planned integration. We are searching for a Reservoir Engineer for our Technology team located in Sugar Land, Texas . As a...  ...analytics Minimum Qualifications: ~ Bachelor's degree in Petroleum, Chemical or Mechanical Engineering ~6 years of relevant...