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Latest Jobs

Sep 14, 2021
Primar y Function:  The person in this position is responsible for evaluating novel concepts and developing medical products and processes under design control requirements and within the setting of a project team.   Essentia l Job Function/Duties: Work as an interactive member of a team, communicating with leadership to plan, complete and report results of experiments, tests, prototype development, literature surveys, etc. that contribute to projects. Gather clinical application information, performance requirements and user needs; perform requirements and risk analyses. Remain current with and apply FDA 21CFR820, ISO 13485 and ISO 14971 requirements. Design, coordinate and execute design verification and product, process, and method validation activities. Assure that project deliverables and tasks are technically excellent and completed in a timely fashion. Document deliverables (reports, design documents, manufacturing documents, etc.). Ensure that...
Cook Advanced Technologies West Lafayette, IN, USA Full time
Sep 13, 2021
$80,000 - $100,000 yearly
Dymedso is looking for a medical device engineer to join our growing team in Lachine. The new hire will be part of a small engineering team and will be able to work on multiple projects and various aspects of the products. With a large spectrum of tasks related to product development, prototyping, testing, certification & production, the person will have the opportunity to apply its engineering skills to different sectors in the company. ISO 13485 Write & maintain engineering standard operating procedures Lead the Risk Management Team in the conduct and documentation of process risk analyses Supporting engineering & production change control activities, including maintenance of Control Plans Write and manage ECRs (Engineering change requests) Corrective and Preventive action leadership (CAPA) including root cause analysis and action plans Manage & organize R&D/Production’s electronic documentation IEC 60601 Participate...
Dymedso Lachine, Montreal, QC, Canada Full time
Sep 09, 2021
The Senior Systems Engineer will be working with the product, platform, and software engineering team to provide design contr ol and software/systems development guidance. As a Senior Systems Engineer, you'll apply cutting - edge techniques and technologies, build great products, develop reusable platforms and grow great teams. You'll be a key technology and process leader at Orth ogonal and intimately involved in almost every aspect of a solution lifecycle from project inception, engineering design, implementation to maintenance and continuous improvement. These solutions include cloud - based applications, mobile, web, and web serv ices for the life science industry, and are used to manage, process, and store patient health and medical device data to be used for patient diagnosis and treatment. Important aspect of the role: You're comfortable in a client facing role, being a technology leader as well as a team leader. What will...
Orthogonal Remote (Chicago, IL or Remote) Full time
Sep 09, 2021
Who are we looking for? Orthogonal is seeking a candidate for a Principal Software Engineer who will apply cutting-edge techniques and technologies, build great products and great teams that integrate devices, sensors, mobile and cloud computing. What will you do as a Principal Software Engineer? Given a vision for a product by the client, extract technical requirements that need to be addressed by a software and hardware solution Convert requirements into an architecture and design that will become the blueprint for the solution being created, and that supports a specific set of features Provide leadership in identifying, analyzing and responding to project risk Develop presentations, overviews and documentation that communicates the design to both the client and technical team members Assist in taking the design and converting it to raw epics that can be expanded upon and groomed into specific user stories utilized by the UX and development teams Participate...
Orthogonal Remote (Chicago, IL or Remote) Full time
Sep 02, 2021
$35.00 - $100.00 hourly
This is a part time job for 10-20 hrs/week for 6-8 months with a potential to become full time. The applicant will be asked to help complete Kaya17's eQMS system and assist with completion of the DHF.  The ideal applicant will have had at least one year's experience working with QMS systems in a medical device (Diagnostics) company and will have a Bachelor's degree in a science or engineering subject.  The candidate will be asked to be on site at least one day in the week and will be an independently motivated individual with drive to accomplish the mission.  The position starts immediately.  The candidate should write a short cover letter along with their resume. 
Kaya17, Inc Remote (Combination of remote and onsite (Flexible timings)) Part time
Sep 01, 2021
$65,000 - $85,000 yearly
CenterMed, Inc. is a medical device startup focusing on developing patient-matched maxillofacial surgical plans and accessories. We are looking for a Quality Engineer to join our CenterMed team! In this role, you will be working with other department partners to deliver safe and effective medical device designs for manufacturing, compliant with CenterMed policies and procedures. You will provide quality assurance support to company functions with a focus on process improvements and compliance to design controls in accordance with ISO13485, ISO 14971, 21 CFR Part 820. Job Responsibilities: Have a proven track record as a lead engineer and/or hands-on management Mentor, develop, and empower your team by providing them with the knowledge, confidence, and drive to make independent decisions that will lead to their personal and professional success, as well as the ability to become technical leaders. Create metrics to track success and report both internally and...
CenterMed Full time
Sep 01, 2021
$60,000 - $80,000 yearly
CenterMed, Inc. is a medical device startup focusing on developing patient-matched maxillofacial surgical plans and accessories. We are looking for a Quality Engineer to join our CenterMed team! In this role, you will be working with other department partners to deliver safe and effective medical device designs for manufacturing, compliant with CenterMed policies and procedures. You will provide quality assurance support to company functions with a focus on process improvements and compliance to design controls in accordance with ISO13485, ISO 14971, 21 CFR Part 820. Job Responsibilities: Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained Executes CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis Supports regulatory and...
CenterMed Remote (Walnut Creek, CA, USA) Full time
Sep 01, 2021
$60,000 - $80,000 yearly
Job description CenterMed, Inc. is a medical device startup based in the exciting bay area. CenterMed, Inc is determined and focused on developing patient-matched maxillofacial surgical accessories. We are looking for a R&D Engineer to join our CenterMed team.   ESSENTIAL DUTIES and RESPONSIBILITIES: ·      Design, develop and optimize patient-matched products ·      Generate work instructions, test methods, engineering models and drawings/prototypes to characterize product and process specifications ·      Develop test strategy based on design requirements derived from voice of customer, and execute protocol, testing, data analysis, and reports required for regulatory submissions ·      Identify issues, conduct root cause analysis, and map out resolution when designing parts, components and sub-assemblies using engineering first principles and appropriate test evaluations ·      Create and update design control documents, including updating risk analysis...
CenterMed Remote (Walnut Creek, CA, USA) Full time
Aug 30, 2021
We’re looking for an experienced Director of Quality Assurance and Regulatory Affairs to join our team of high-performing entrepreneurs and professionals to ensure all necessary compliance of our tests and instruments both under development and in the future. The Director of QA/RA, reporting directly to the Chief Operations Officer, works in conjunction with executive management and company leadership to develop strategic and tactical plans to ensure compliance with national and international quality management system requirements. This individual has the overall responsibility for maintenance and continuous monitoring and improvement of the company's Quality Management System, in conformance with ISO standards, FDA's QSR/GMP requirements, and any other applicable regional in-vitro diagnostic (IVD) regulations. Responsibilities are: Lead and develop the Quality Assurance team Further develop and implement UOL’s Quality Strategic Plan for diagnostic medical devices....
Uh-Oh Labs Full time