Overview
On Site
BASED ON EXPERIENCE
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
QUALITY
QA
DESIGN
PRODUCT DEVELOPMENT
NEW PRODUCT DEVELOPMENT
NPD
DESIGN CONTROLS
DESIGN CONTROL
DESIGN VERIFICATION
DESIGN VALIDATION
VERIFICATION AND VALIDATION
V and V
ISO 13485
ISO 14971
ISO 10555
ISO 80369
ISO 7864
FDA
FDA QSR
QSR
EUMDR
MDR
MEDICAL DEVICE COMPANY
MEDICAL DEVICE COMPANIES
BOSTON SCIENTIFIC
MEDTRONIC
BIOTECH
MEDICAL DEVICES
MEDICAL DEVICE
THERMO FISHER
HOLOGIC
SIEMENS
PERKINELMER
HAEMONETICS
COVIDIEN
MERCK
PFIZER
JOHNSON AND JOHNSON
J and J
MEDTRONIC
STRYKER CORPORATION
BOSTON SCIENTIFIC
ABBOTT LABORATORIES
ZIMMER BIOMET
3M HEALTH CARE
THERMO FISHER SCIENTIFIC
EDWARDS LIFESCIENCES
BAXTER INTERNATIONAL
GE HEALTHCARE
PHILIPS HEALTHCARE
DANAHER CORPORATION
VARIAN MEDICAL SYSTEMS
CARDINAL HEALTH
ILLUMINA
INC.
DENTSPLY SIRONA
ALIGN TECHNOLOGY
HILL-ROM HOLDINGS
SIEMENS HEALTHINEERS
BD BECTON
DICKINSON AND COMPANY
SMITH and NEPHEW
HOLOGIC
INC.
RESMED
BAUSCH HEALTH
EXACT SCIENCES
ABIOMED
TELEFLEX INCORPORATED
INTEGRA LIFESCIENCES
ORASURE TECHNOLOGIES
GLOBUS MEDICAL
CANTEL MEDICAL CORP
CONVATEC
DRAEGER MEDICAL SYSTEMS
CAGENT VASCULAR
B. BRAUN MEDICAL INC.
JOHNSON and JOHNSON
Job Details
Quality Engineer III
Qualifications:
Preferred:
If this job is a match for your background, we would be honoured to receive your application!
Job Summary: Talent Software Services is in search of a Quality Engineer for a contract position in Arden Hill, MN. The opportunity will be one year with a strong chance for a long-term extension.
Position Summary: This Senior Design Assurance Engineer on the Design Quality Assurance (DQA) team directly supports medical device product development from concept through commercialisation and sustainment within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This engineer will support the DQA team in various quality-related activities within high-performing teams on high-visibility issues impacting Active Implantable & Accessories product performance. This individual will collaborate and partner with Research & Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post Market, and other Quality organizations to achieve optimal results.
Primary Responsibilities/Accountabilities:
- Understanding and application of design engineering concepts and tools, including Design Failure Modes and Effects Analysis (DFMEA), Design Verification & Validation, Benchmarking, Test Method Validation, and Design Transfer.
- Apply sound, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues, including CAPA work.
- Review and approve quality records, including product specifications, design verification test protocols, and design verification test reports.
- May lead or contribute to collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Not.
- Creates, maintains, and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues.
- Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.
- Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Monitors and ensures compliance with company policies and procedures.
- Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Qualifications:
- Bachelor's degree in an engineering or related discipline with 5+ years of relevant experience
- Experience in the medical Device industry; Knowledgeable in Quality System Regulations, Medical Device Regulation, ISO 14971 and ISO 13485 Quality Standards with a focus on design controls and design optimization.
- Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
- Ability to collaborate and influence across multiple, cross-functional teams
- Demonstrated technical problem-solving & data analysis capabilities
Preferred:
- Experience in design engineering or process development, including test method validation, process validation, and continuation engineering.
- Experience writing specifications, test protocols, and technical reports.
- Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, and 5 Why's.
- Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA).
- Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).
- Adaptable and effective collaborator in a team environment or in self-directed work.
- Strong ability to successfully multitask and demonstrate adaptability
- Strong communication skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise.
If this job is a match for your background, we would be honoured to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!
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