Seeking a balanced and nimble Product Engineer. S/he will report to the VP of R&D and will be responsible for supporting the product development process through direct technical contributions in…
Class III Med Device company specializing in transcatheter aortic valve replacement (TAVR) systems. Job Responsibilities: Develop components or subsystems for transcatheter heart valves and delivery systems in accordance with quality…
This is a new position focused on NPI, and will help develop new manufacturing processes and transfer products from R&D into Manufacturing. Devices: Catheter-based Interventional devices, plastic components, NiTinol Components,…
The person in this role will handling challenging new product development assignments in a fast paced, small team environment. Needing a versatile engineer with a strong medical device background, who…
ESSENTIAL FUNCTIONS: Identifies issues to be addressed and areas of concern where IVDR may hinder the registration and sale of Quidel products Prepares and communicates IVDR project-related documentation and budgets…
This role will need verification test expertise to all levels of product development, from hardware subsystem and prototype testing, to system level verification and software testing, and medical device compliance…
What are the day to day responsibilities? • Product working: new Infusion pump – 3-8+ years in V&V background (Validation & verification) and Test Method Validation (TMV) -Team focused on…
We are searching for a Senior R&D Engineer with catheter development experience for a highly regarded, rapidly growing, Class III medical devices company located in Irvine, CA. The Senior R&D…
As a Project Manager – you will be responsible for coordination, planning, and ensuring regulatory requirements are met for ongoing medical device and software product development at Wave Neuroscience. Engage…
The Project Engineer operates in a matrix organization to transfer designs, products, technologies, equipment, and acquired company assets to the site and where applicable into production at the site. The…
The Regulatory Specialist helps create, develop and maintain materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. Works independently as…
Education and Experience: Bachelor’s Degree in Engineering or Scientific field Required Desired Skills: Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)…
Job Overview: This is a Quality Engineering role (design assurance) and will support manufacturing transfer and DHF remediation. Responsibilities may include the following and other duties may be assigned: Support…
Responsibilities Work with our customer base in the medical device industry to develop strong working relationships on an ongoing basis while implementing, troubleshooting resolving issues as they arise, and helping…
Key Responsibilities Guide the development, planning, and execution of regulatory submission strategies in line with corporate and program goals and timelines through alignment of key activities Lead the preparation and…
Day to Day: Going through documentation for a new product they recently launched Staying compliant to internal SOPs and communicating any gaps to Monica and other engineering and regulatory personnel…
The Senior Regulatory Affairs Specialist will lead the team in preparing global regulatory documents and submissions, according to standards, for all products. This key team member will play a crucial…
Job Description: Responsibilities:- Creates investigation files in the Client Global complaint system (Trackwise). Performs complaint investigations for all BMD and OEM manufactured products. Manages completion of assigned complaint investigation files and…
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program,…
Looking for a talented Electrical Compliance Engineer to join our team and working with a medical device manufacturing organization located in the Bay Area. You will be responsible for leading…