R&D Medical Device Engineer
By Abras Life sciences At Dallas, TX, United States
2-3 years of relevant experience in Research and Development within the Medical Device Industry.
Independently conduct smaller approved projects, making suggestions for improvements based on current technical knowledge.
Strong multitasking skills to work efficiently under pressure and meet project deadlines.
Bachelor's Degree in Engineering or a related field from an accredited university.
Solve routine design and engineering challenges with minimal assistance, demonstrating technical expertise in your field.
appropriate techniques and methods to complete assignments within negotiated deadlines, following general instructions.
Sr. Medical Device Manufacturing Design Engineer (Min 5+ Years Exp/Must Have Exp In Catheters, Implants, Ancillary Products Or Similar)- Greencard Or Usc
By JobsPro Staffing (JPS) At Campbell, CA, United States
Required Skills, Abilities & Experience
Design, execute, and analyze experiments using sound statistical methodology. Participate in risk management activities, including development and ownership of process FMEAs.
Experience with quality system documentation requirements and test protocols.
Develop manufacturing processes by applying engineering knowledge and product design, fabrication, assembly, tooling, and materials.
Improve manufacturing efficiency through planning and evaluation of workflow, space requirements and equipment layout.
Calculate production, labor, and material costs; manage and adjust production schedules to meet demand.
Medical Device Verification Engineer (Not A Qa Role)
By Systems Ally At San Jose, CA, United States
1) Python (hands on, able to build automation)
Design and Implement appropriate test protocols, test harnesses and test automation tools
Work with complex electro-mechanical systems, deploying new software releases and running the test protocols on the systems
Write thorough test plans/test protocols, test cases, test scripts and test scenarios.
Submit FDA valid documents and reports for all the products mentioned above.
Have a good understanding of FDA forms and protocols is a plus
Quality Engineer Ii - Medical Device
By Abbott Laboratories At , Santa Clara $72,100 - $144,100 a year
Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
Risk Management - Applies basic Risk Management principles to work.
Participates in the development or modification of Risk management files.
Complaint Evaluation - Investigates complex complaints with management oversight.
Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g.FMEAs).
Staff Engineer, Hardware, Mechanical R&D - Medical Device
By Werfen At , San Diego, 92121
Solidworks Data Management experience is required.
Minimum Knowledge & Experience required for the position:
Eight (8) years previous relevant industry experience required, preferably within a regulated medical device or pharmaceutical environment.
Evaluate and select appropriate components and technologies, considering both performance and manufacturing requirements.
Experience with the following tools/methods: FEA, Six Sigma, DOE, FMEA, Minitab, Arduino, Word, Power Point, Excel is highly desired.
Provide technical leadership to project teams.
Medical Device Defense Engineer
By HonorHealth At , Scottsdale, 85258

Overview: Looking to be part of something more meaningful? At HonorHealth, you’ll be part of a team, creating a multi-dimensional care experience for our patients. You’ll have opportunities to make ...

Quality Engineer(Medical Device, Otc, Drug + Cosmetic) - Hartland, Wi
By Medline Industries Inc At , Hartland
Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
Knowledge / Skills / Abilities
Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
At least 2 years of experience in the Quality or Engineering.
Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook ).
Chemical Engineer Medical Device
By BD At , Glens Falls
Knowledgeable on materials for product designs in areas of responsibility.
Demonstrates strong communication skills across all levels of the organization, both internal and external.
General knowledge of basic physics and chemistry.
Basic knowledge of structure-property-process relationships of polymer systems.
Hands on experience working in a polymer chemistry laboratory.
Experience in a regulated environment.
Sr Medical Device Engineer
By Dexcom At , San Diego, Ca $91,400 - $152,300 a year
You have knowledge and direct experience handling raw and processed datasets of various sizes
You bring a track record of demonstrated knowledge and experience in biosensor development and testing
You have experience with modeling stochastic processes (Monte Carlo or similar)
You have strong analytical and experimental skills for characterization of materials and biosensor components
You have excellent collaboration, communication (written and verbal), and interpersonal skills
A full and comprehensive benefits program.
Quality Engineer (Medical Device)
By Regeneron At , East Greenbush, Ny
You have experience with device risk management activities
Participating in device risk management activities including UFMEA, DFMEA, PFMEA
You have knowledge of the combination device development process
Reviewing design and development paperwork and records for compliance to internal procedures and regulations
Ensuring accurate justification of statistical analysis and hypothesis testing
Reviewing technical reports as well as documents for Design History Files
Equipment Validation Engineer(Medical Device)
By Saraca Solutions At , , Nj
Must have experience in medical device process and equipment validation
Experience in medical device technical writing
Experience is ISO 13485, ISO 14971, 21 CFR Part 11
Follow all safety and current Good Manufacturing (cGMP) requirements within the plant
Develop and execute Field Acceptance Testing (FAT) and Site Acceptance Testing (SAT) using User Requirement Specifications (URS)
Lead validation engineering activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities
Executive Assistant, Device Design Group
By Amazon At Sunnyvale, CA, United States
Management of complex calendar scheduling.
Experience with Microsoft Office products and applications
5+ years of executive assistant experience
Bachelor’s Degree or equivalent experience
Intermediate knowledge of MAC products.
Experience with domestic and international travel coordination.
Quality Engineer - Medical Device Manufacturer
By Jobot At Anaheim, CA, United States
Collection and trending of key quality indicators for management review.
ASQ Certifications such as Manager of Quality/Organizational Excellence, Quality Engineer, Quality Auditor, Supplier Quality Professional, etc.
Conduct internal quality audits to ensure compliance to Quality System and regulatory requirements.
Facilitate receiving inspection and first article inspection activities. Help establish receiving inspection requirements for materials and any needed
Facilitate calibration activities. Help establish calibration requirements for measuring equipment and test fixtures as needed.
Assure Quality System Processes are in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device
Medical Device Electrical Engineer
By HCP Technologies LLC At Cambridge, MA, United States
Lead communication with remote teams as Electrical Engineering lead
Must have experience integrating, testing, and verifying complex electrical systems.
Experience with schematic capture and PCBA testing
Extensive experience working with consultants, outside partners, contract manufacturer and suppliers.
Responsible for electrical system design and documentation compliance with medical safety and EMC/EMI standards
Create documentation adhering to quality procedures, regulations, standards, and industry best practices under Design Control.
Quality Engineer (Medical Device)
By Abras Life sciences At Greenville, NC, United States
• Conduct risk assessments to identify potential hazards and to ensure that products meet safety requirements.
• Ensure compliance with regulatory requirements, including FDA regulations, ISO standards, and other applicable regulations.
• Minimum of 3 years of experience as a Quality Engineer in the medical device industry.
·Knowledge of design control and verification/validation processes.
• Develop and implement quality control plans and procedures, including documentation, training, and auditing processes.
• Conduct statistical analysis of quality data to identify trends and opportunities for improvement.
Research And Development Medical Device Engineer
By Cresilon At Brooklyn, NY, United States
Working knowledge of FDA requirements as per 21 CFR 820 and ISO 9001, ISO 13485:2003 and ISO 14971:2007 is strongly preferred.
Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety.
Apply strong problem-solving skills to find solutions to complex problems.
Manage part-time staff as a research leader and mentor for ongoing research projects.
Responsibilities may include other duties as assigned and as requiread
Experience gathering user needs, translating them to technical inputs, developing viable V&V (Design Verification and Validation) plans required.
Medical Device Electrical Engineer
By TMC At , New York, Ny
Proven experience in designing electrical systems and components for medical devices or similar regulated industries.
Knowledge of safety considerations, electromagnetic compatibility (EMC), and electrical safety standards for medical devices.
Experience with prototyping, testing, and measurement equipment for electrical systems.
Excellent problem-solving skills and ability to troubleshoot and debug complex electrical systems.
Effective communication and teamwork abilities to collaborate with cross-functional teams.
Yearly training personal budget for Coaching & Education
Validation Quality Engineer Ii (Medical Device)
By STAAR Surgical At Monrovia, CA, United States
• Excellent project management, organization, writing, communication and presentation skills required.
10. Compile Quality metrics, analyze trends and report to Quality Management.
13. Perform additional duties as assigned by Management.
• Bachelor’s degree, preferably in Engineering or sciences or equivalent combination of education/experience.
9. Coordinate contractor qualification activities with appropriate departments.
• Experience in vision care or intraocular lens industry preferred.
Validation Quality Engineer (Medical Device)
By STAAR Surgical At Lake Forest, CA, United States
•Excellent project management, organization, writing and presentation skills required.
.Prepare and report appropriate metrics to executive management.
•Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.
•A Bachelor of Science (BS) in science or engineering, advanced degree preferred.
•Solid understanding of investigation techniques including design of experiments and root cause analysis.
•Demonstrated understanding and application of Quality System Auditing and Analysis
Principal Mechanical Engineer, Medical Device Solutions
By Battelle At Columbus, OH, United States
Work with management and Team Leads to participate in developmental activities for junior staff
Project or technical task leadership experience in medical device design in an ISO13485 operational environment
Design for manufacturing experience e.g. in plastic injection molding, machined parts, sheet metal, packaging of electronics/cables, etc.
Consumer product design engineer experience
Hands on general lab skills e.g. building and testing prototypes
Experience using FEA analysis tools with a strong preference for ANSYS and/or Abaqus and plastic part experience