Iso 13485 jobs in burlingame, ca

Foster City, California

•

Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 117,895.00 - 152,570.00 per year

Sr Clinical Engineer

Campbell, California

•

Today

Title: Sr Clinical Engineer This position is based in our Campbell, California offices. This position is on-site and full time. Why Imperative Care? Do you want to make a real impact on patients? As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs o

Full-time

USD 140,000.00 - 150,000.00 per year

COMPONENT ENGINEER 3

Sunnyvale, California

•

2d ago

Description: Position Overview The Supplier Engineer is responsible for ensuring suppliers reliably support plant production by meeting Intuitive requirements for quality, delivery, capacity, cost, and service. This role is highly execution-focused and serves as the primary technical interface between the plant and suppliers to resolve line-impacting issues, improve supplier manufacturing processes, and maintain stable production operations across multiple product families. The Supplier

Easy Apply

Contract, Third Party

$60 - $75

QMS Analyst

Burlingame, California

•

Today

Job#: 3045579 Job Description: Apex Systems is seeking a Quality System Analyst to support a clients Hearing Enhancement and wearable technology programs. This role will focus on post-market surveillance (PMS), complaint investigations, and customer quality activities supporting regulated products. The ideal candidate will have experience handling product complaints, conducting root cause investigations, supporting CAPA activities, and working within a Quality Management System in a regulated en

Easy Apply

Full-time

$35 - $45 per hour

Sr. Engineer, R&D - Pleasanton, CA

Pleasanton, California

•

Today

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Leads hands-on innovation for medical devices, focusing on early-stage co

Full-time

USD 120,000.00 - 135,000.00 per year

Sr. Mechanical Engineer / Project Manager

Milpitas, California

•

Today

Acorn is looking for an experienced Sr. Mechanical Engineer that can also manage projects to take a technical leadership position and help guide our team of engineers to create innovative, world class products. This position requires a broad design engineering background in robotics and automation. Acorn has 33 years' experience as an industry leader in product development consulting, partnering with clients ranging from high profile start-ups to Fortune 100 & 500 companies. Every day we are pri

Full-time

Senior Mechanical Engineer / Project Manager- Milpitas

Milpitas, California

•

Today

Full-time

Software Engineer - Medical Applications & Algorithms

San Francisco, California

•

Today

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integr

Full-time

USD 130,000.00 - 150,000.00 per year

Regulatory Affairs Specialist 4

Sunnyvale, California

•

2d ago

Primary Function of Position The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses. Essential Job Duties Provide regulatory guidance to product teams, develop regulatory plans, a

Easy Apply

Third Party, Contract

$60 - $60

Mechanical Engineer

Dublin, California

•

Today

Roles & Responsibilities: Act as technical lead for mechanical design within electromechanical medical device programs. Own the mechanical architecture and interfaces for electro-mechanical subsystems including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations. Lead end-to-end mechanical design activities from concept, feasibility, and prototyping to design freeze and production release. Translate user needs, system requirements, and electrical/software

Full-time

Systems Engineer

Dublin, California

•

Today

Responsibilities: Lead system-level design, development, and integration of medical device products across hardware, software, mechanical, and electrical domains. Design and review hardware architectures, including sensors, actuators, controllers, and embedded subsystems. Develop and validate control systems for precise XYZ multi axis mechanical motion, motion profiling, and closed-loop feedback systems. Collaborate with mechanical engineers to define and validate kinematic designs, tolerances,

Full-time

Sr Sourcing Engineer

Campbell, California

•

Today

SUMMARY: An individual in this role uses solid experience to collaborate with materials management team in sourcing identification, in change or improvement assessments of quality and service level including analysis of cost on sourced components and evaluation of supplier manufacturing processes. This position serves as key liaison between suppliers and production units, executing supplier/company-initiated changes and resolving technical problems. ESSENTIAL DUTIES AND RESPONSIBILITIES include

Full-time

USD 109,000.00 - 127,000.00 per year

Director of IT, Engineering and PLM Applications

Sunnyvale, California

•

Today

Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide. We're a team of engineers, clinicians, and innovators united by one purpose: to make surger

Full-time

USD 223,800.00 per year

Hardware Engineering Manager - Robotics R&D

Santa Clara, California

•

Today

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 134,000.00 - 231,150.00 per year

Staff Optical Engineer

Milpitas, California

•

Today

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biol

Full-time

USD 135,500.00 - 216,800.00 per year

Auditor

Remote or Chicago, Illinois

•

Yesterday

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

Easy Apply

Full-time

$40.0000 - $43.0000

Cold Chain Pharmacy Distribution Engineer

Sunnyvale, California

•

Today

Full-time

USD 139,400.00 per year

Senior Test Engineer

San Francisco, California

•

Today

Full-time

USD 165,000.00 - 205,000.00 per year

Director, ATE Test Engineering

Santa Clara, California

•

Today

Description Invent the future with us. Ampere is a semiconductor design company for a new era, leading the future of computing with an innovative approach to CPU design focused on high-performance, energy efficient AI compute. As a pioneer in the new frontier of energy efficient high-performance computing, Ampere is part of the Softbank Group of companies driving sustainable computing for AI, Cloud, and edge applications. Join us at Ampere and work alongside a passionate and growing team - we'd

Full-time

USD 279,500.00 - 419,500.00 per year

Principal Clinical Engineer

Campbell, California

•

Today

Title: Principal Clinical Engineer This position is based in our Campbell, California offices. This position is on-site & full-time Why Imperative Care? At Imperative Care, we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke - a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Imperative Care changing the way stroke is treated, but also br

Full-time

USD 188,000.00 - 220,000.00 per year

Iso 13485 jobs in Burlingame, CA, USA