Medical Device Component Development Engineer
Full-time
PB consulting
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
Vacancy posted 29 days ago
Similar jobs that could be interesting for youBased on the Medical Device Component Development Engineer in Blue Ash, OH vacancy
$117k - $201.25k
...Ohio to support our handheld medical device business. This hybrid role... ...procedures.Our team of engineers, designers, and technical specialists... ...to support our New Product Development (NPD) pipeline. You will... ..., metal and electrical components required Knowledgeable in the...Medical deviceFull timeContract workLocal areaImmediate startRelocation3 days per week- Company DescriptionMedical Device/ Pharmaceutical Company.Job DescriptionThe Package Development Engineering Contractor is responsible for... ...group to deliver packaging components in a timely manner for Research... ...for this role along with medical device experience. • Experience...Medical deviceFor contractorsWork experience placement
- Job Title: Systems Engineering (Principal Engineer) Job Summary Johnson & Johnson is seeking... ...to support complex product development programs by applying systems engineering... ...working in regulated industries such as Medical Devices, Healthcare, Life Sciences, or other highly...Medical device
- ...Skills: Understanding of Medical Device domain Know how on ISO... ...Understanding of GD&T, Engineering principles, Product designs... ...in NX, SolidWorks; Concept Development; and Engineering Documentation... ...Coordination with device and/or component suppliers...Medical device
Syntricate Technologies
Blue Ash, OH3 days ago - R&D Engineer Location: Cincinnati, OH (100% On-Site) Engineer the processes that give medical devices a second life. Vein360 is looking for an R&D Engineer to support the design and development of processes behind restoring previously used healthcare products to like...Medical deviceFull timeContract workLocal area
- ...Role Overview: This Senior Medical Device Quality Engineer role involves leading multiple high-priority lifecycle change projects from concept... ...Serve as the technical interface with suppliers for component development, DFM reviews, tooling readiness, process capability,...Medical deviceFull time
Prophecy Technologies
Blue Ash, OHa month ago - ...Role Overview: This Senior Engineer role is critical for leading high-priority lifecycle change projects within the medical device or other regulated industries. The position... ...interface with suppliers for component development, DFM reviews, tooling readiness, process...Medical deviceFull time
Prophecy Technologies
Blue Ash, OH6 days ago - ...Title : Mechanical Product validation Engineer Location: Onsite. Cincinnati, OH... ...reprocessing validation for reusable medical devices. Experienced in developing test methods... ...functional stakeholders. • Support development and completion of associated risk management...Medical device
Ruri Software Technologies LLC
Cincinnati, OH2 days ago - ...Mechanical, Manufacturing, or Industrial Engineer with 5-10 years of experience in medical device equipment development and manufacturing. Expertise in assembly equipment... ...for each assigned station. • Delivers component, assembly, and supply chain strategy project...Medical device
Omni Inclusive
Cincinnati, OH3 days ago - AtriCure, Inc. is seeking a Process Engineer to support manufacturing processes and drive continuous improvement across assembly lines. You will troubleshoot line issues, perform root cause analyses, and lead CAPA activities to ensure product quality and reliability. The...Medical device
- ...Equipment Engineer Our client, a IT Services and Consulting company... ...understanding the equipment development road map, understanding... ...assigned station. Delivers component, assembly, and supply chain... ...5-10 years of experience in medical device equipment development and manufacturing...Medical device
ICONMA
Cincinnati, OH5 days ago - ...Description Job Description R&D Engineering Technician Location:... ...with technology that gives medical devices a second life. Vein360... ...across the full product development life cycle from prototyping... ...lab operations, including component ordering, stock management,...Medical deviceFull timeInternshipWork at officeLocal area
Vein360
Cincinnati, OH26 days ago - We are seeking a Mechanical Product Validation Engineer with hands‑on experience in cleaning, sterilization, and reprocessing validation for reusable medical devices. The ideal candidate will support product development by developing and executing validation studies, creating...Medical device
- Johnson & Johnson MedTech is seeking a Senior Clinical Engineer for the OTTAVA Robotic Surgical System team in Cincinnati, Ohio. You... ...regulatory, clinical, and product teams in a fast-paced medical device environment. #J-18808-Ljbffr 6267-Auris Health Inc. Legal EntityMedical device
- Belcan seeks a Mechanical Product Validation Engineer in Cincinnati to lead cleaning, sterilization, and reprocessing validation for reusable medical devices. You will plan feasibility studies, develop test methods, and perform GR&R analyses to ensure safety and compliance...Medical device
- ...Tech Services | P5 Group in Cincinnati, OH is seeking a Mechanical Product Validation Engineer responsible for developing and executing validation studies for reusable medical devices, focusing on cleaning, sterilization, and reprocessing validation. The role involves creating...Medical device
$50 - $60 per hour
Job Title: Mechanical Product Validation Engineer Pay Rate: $50-60/hr Duration: 24-... ...Engineer with 5-10 years of experience in the medical device industry, specializing in cleaning,... ..., validation activities, test method development, and GR&R studies to ensure product safety...Medical deviceContract workLocal areaImmediate startBelcan
Cincinnati, OHa month ago- ...for our Mason, OH facility. You will assemble small to medium components into quality finished products under ISO and regulatory... ...a fast-paced environment and opportunities for growth as you contribute to high-quality medical devices. #J-18808-Ljbffr AtriCure, Inc.Medical deviceDay shift
- ...Reference26-00530 Job Summary: Lead mechanical design and development activities for medical device programs Strong focus on 3D stack-up and tolerance... ...Product Development (NPD) lifecycle execution Ensure engineering deliverables are met with high technical ownership Roles...Medical device
- ...Ablation System is the first medical device to receive FDA approval for... ...POSITION SUMMARY: The Process Engineer is responsible for on-going... ...team (quality, product development, regulatory) to address product... ...Review of proposed component tolerances and input to manufacturing...Medical deviceTemporary workLocal areaWorldwide
AtriCure International
Mason, OH1 day ago - ...Job summary : Manufacturing Process Engineer with 5-10 years of experience in manufacturing... ...engineering and operations within the medical device industry. Responsible for driving... ...cost efficiency. Experience in process development, validation (IQ/OQ/PQ), PFMEA, CAPA/Client...Medical device
Omni Inclusive
Cincinnati, OH3 days ago - ...staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India... ..., and long-term client success. Position: Process Engineer Location: Ohio Duration: Long Term Job Overview...Medical device
Stark Pharma Solutions Inc
Cincinnati, OH2 days ago - ...proficiency Roles & Responsibilities • Perform dimensional inspections of medical devices and components using contact and non contact metrology equipment • Collaborate with engineers to understand measurement requirements and recommend optimal inspection...Medical deviceFull time
Diverse Lynx
Blue Ash, OH1 day ago - Belcan Corporation seeks a Mechanical Product Validation Engineer with 5-10 years of medical device experience, focusing on cleaning, sterilization, and... ...Regulatory, and external partners to support product development, design reviews, and launches in a regulated #J-1880...Medical device
- ...experience in dimensional inspection and precision measurement for medical device components. The ideal candidate will be skilled in contact and non-... ..., and white light scanning systems. Read and interpret engineering drawings and GD&T specifications. Collect, analyze, and...Medical device
Neshent Technologies
Silverton, OH4 days ago - ...Manufacturing Engineer Location: Indiana IN & Ohio Employment Type: Contract, Long... ...ideal candidate will have a background in medical device or regulated manufacturing environments... ...Support machining operations, ensuring components meet quality, cost, and delivery goals....Medical deviceContract work
Kasmo Global
Kings Mills, OH2 days ago - ...and problem-solving capability • Familiar with test method development and variety of chemical characterization methods such as... ...Skill • Understanding of GMP and regulated lab environments (medical device/pharma preferred) • Experience supporting IQ/OQ/PQ for lab...Medical deviceFull time
Diverse Lynx
Blue Ash, OH3 days ago - ...skilled Manufacturing Test Engineer to support testing, validation... ...setup, and process development activities within a regulated... ...documentation practices, and medical device regulatory requirements.... ...document test configurations for components, assemblies, and...Medical deviceWork experience placement
Katalyst Healthcares and Life Sciences
Cincinnati, OH2 days ago - ...is looking for a Manufacturing Process Engineer for their Cincinnati, OH location.... ...manufacturing process through a structured process development approach. Perform scrap and cost... ...| Continuous Improvement | Medical Device Manufacturing | Supplier Validation | Root...Medical device
ICONMA
Cincinnati, OH3 days ago - Pentangle Tech Services | P5 Group in Cincinnati, OH seeks an experienced Quality Engineer to support QA, validation, and manufacturing activities for medical device products in a regulated environment. The role emphasizes quality systems, process validation, risk management...Medical device
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Medical Device Component Development Engineer. Be the first to apply!
Related searches
- medical device Blue Ash, OH
- career development Blue Ash, OH
- leadership development Blue Ash, OH
- training development Blue Ash, OH
- application development Blue Ash, OH
- training and development intern Blue Ash, OH
- client development Blue Ash, OH
- r&d engineer medical device
- quality engineer medical device
- medical device compliance engineer