ISO 13485 jobs

R&D Engineer Medical device exp (ISO 13485, ISO 14971)

Franklin Lakes, New Jersey

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2d ago

R&D Engineer Prior experience mandatory in medical devices domain, Plan & execute validation activities in alignment with ISO 13485, ISO 14971, Responsible for managing and overseeing the daily operations and projects at a clients location, acting as the primary link between the client, project team, Experience in R&D New product development & Design Change Management. Experience in Product life cycle management, developing, Risk Management activities Design Verification & validation activities

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Third Party, Contract

$60 - $70

Sr Engineer Process

California

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Today

Job Description Dar seguimiento a problemas de calidad relacin con Almacn y Produccion.Gestionar No Conformidades (NCs) y acciones correctivas/preventivas (CAPA).Coordinar liberacin de material y producto en almacn bajo estndares regulatorios.Liderar y soportar auditoras internas, externas y de clientes.Implementar y dar seguimiento a indicadores de calidad en procesos de almacn y distribucin.Colaborar con equipos multifuncionales (produccin, logstica, compras, proveedores).Ingeniera Industrial

Full-time

Regulatory Compliance Specialist

Minneapolis, Minnesota

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7d ago

TITLE: Regulatory Compliance Specialist LOCATION: Plymouth, Minnesota ANTICIPATED DURATION: 6 Month Contract to Hire Synergis client, a leading veterinary health company, has engaged us in a search for a Regulatory Compliance Specialist to augment their growing team to launch a new product! The Regulatory Compliance Specialist will play a key role in making sure that the products and company processes comply with the laws, standards, and regulations that govern these new products. Regulatory

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Contract

$45 - $50

Sr. Software Instrument Verification & Validation Engineer (Lead)

Hybrid in Rochester, New York

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Today

Sr. Software Instrument Verification & Validation Engineer (Lead) Location: Rochester, NY Hybrid (4 days onsite, 1 day remote) Employment Type: Full-Time | Direct Hire with Client Travel: Up to 10% Overview Our client, a leader in the medical device industry, is seeking a Senior Software Instrument Verification & Validation Engineer (Lead) to drive the formal verification and validation of complex medical devices in compliance with FDA regulations. This individual will lead a highly collabora

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Full-time

Up to $100,000

Automation Engineer

Indianola, Pennsylvania

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8d ago

Are you interested in working with the World s leading AI-powered Quality Engineering Company? Ready to advance your career, team up with global thought leaders across industries and make a difference every day? Join us at Qualitest! We are looking for an Automation Engineer to join our growing team in Indianola, PA United States! Skill & Competency Requirements: Bachelor s degree in Engineering, preferably Computer, Electronics, Electrical.Minimum of 5 years or more experience in automated test

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Full-time

$70,000 - $90,000

Lead System Designer

Waukesha, Wisconsin

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Today

A client of Innova Solutions is immediately hiring a Lead System Designer Position type: Contract Duration: Long Term Contract Location: Waukesha, WI (Onsite) As a Lead System Designer, you will need: Must-have skills for this role: Develop the system architecture based on user needs, functional requirements, and design inputs.Decompose high-level requirements into subsystem and component-level specifications.Lead trade-off studies (performance, cost, reliability, manufacturability).Define inte

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Contract, Third Party

$50 - $55

Senior QMS Process Engineer

Remote or New Jersey

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Today

Responsibilities: Draft, update, and optimize QMS procedures to align with Code beamer upgrades, organizational standards, and regulatory requirements. Collaborate with cross-functional Quality and R&D teams to ensure procedures accurately reflect best practices and compliance expectations. Translate technical and regulatory requirements into clear, practical documentation for end users. Support change management processes, ensuring procedural updates are properly controlled and communicated. En

Full-time

Mechanical Engineer

Chicago, Illinois

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Today

Job Description: We are seeking a hands-on, technically accomplished, Mechanical Engineer. This individual will Create mechanical design of complex infusion hardware with core focus on including their loading, actuation, safety systems, and performance under all clinical conditions. Responsibilities: Create the mechanical design of complex infusion hardware with core focus on. Pumping mechanism design and optimization. Fluid path layout and actuation systems. Loading interfaces that ensure intu

Full-time

Lead System Designer

Waukesha, Wisconsin

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Today

A client of Innova Solutions is immediately hiring for a Lead System Designer Position type: Contract Location: Waukesha, WI-Onsite As a Lead System Designer, you will be responsible for: Job Description: Develop the system architecture based on user needs, functional requirements, and design inputs.Decompose high-level requirements into subsystem and component-level specifications.Lead trade-off studies (performance, cost, reliability, manufacturability).Define interfaces (mechanical, electric

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Contract

$50 - $55

Sr. Mechanical Builder

Normal, Illinois

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7d ago

Title: Mechanical Builder Length of contract: 2-3 months Hours: 40 hours per week Start Date: 10/6-12/22 Location: Normal, IL (2 weeks training Lawrenceville, GA, first) Interview Process: Resume select/review/ Hire (no interview) Interview Times: Send resumes to me and CC Bill, we will send a batch to manager by COB Tuesday, he will let us know which ones to onboard. Product/Application: Assemble control panels, pneumatics, and machines (Automotive) Brief Position Overview: Looking for a Sr.

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Contract

$40 - $50

Senior Manufacturing Engineer

Hybrid in Burlington, Massachusetts

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Today

Details Position: Senior Manufacturing Engineer Needs to have 7+ years of medical device experience Location: Burlington, MA area Duration: Full-Time/Direct (W2)Domain: Medical DeviceInterview: Teams Meetings (2) then potential onsite interview (client pays)VISA: US, , no GC_EAD Industries/Domains to target Medical Device Job Description Senior Manufacturing Engineer Medical Device (Hands-On Role) We re seeking a hands-on Senior Manufacturing Engineer to support daily production and process

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Full-time

$120,000 - $130,000

Junior Medical Devices Quality Associate (1st Shift)(2 Openings)(ONSITE)(No C2C/H1B)

Cedar Creek, Texas

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Today

(No C2C/H1B) Please note that this is a 6 to 18-month contract position. Only local candidates need to apply. Notes: needs to have medical device or life science experience. Also should understand these compliance terms: Ensures compliance with relevant regulations and guidelines, ISO 13485, 21 CFR Paart 820, and IVDR. Shift 1st start time is usually anytime between 8am-9am and plan on working 8 hours days Job Posting Qualifications Bachelor s degree required.Experience ISO 13485, 21 CFR Paart 8

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Contract

Depends on Experience

ATE Software Validation Engineer

Skaneateles, New York

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Today

Roles & Responsibilities: Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or diagnostic devices. Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 CFR Part 820, Part 11, and ISO 13485. Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to define software validation requirements and risk-based testing strategies. Perform IQ/OQ/PQ for ATE systems and ensure traceability from requirements to

Full-time

Senior Validation Engineer

Warsaw, Indiana

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Today

Roles & Responsibilities: Develops and Executes Process Validation Strategies Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment. Ensures Regulatory Compliance Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. nalyses Data and Reports Findings Compiles and analyzes validation data, writes comprehensive reports, and identifies trends for proc

Full-time

Process Validation Engineer

Warsaw, Indiana

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Today

Role & Responsibilities: Develops and Executes Process Validation Strategies Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment. Ensures Regulatory Compliance Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. nalysis Data and Reports Findings Compiles and analyses validation data, writes comprehensive reports, and identifies trends for proce

Full-time

Software Validation Engineer

Plymouth, Minnesota

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Today

Roles & Responsibilities: Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field. Minimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries. Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles. Experience in handling SW development and verification tools. Good exp

Full-time

Staff Validation Engineer (West Hills, CA)

Los Angeles, California

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardotoxic materials Job Description When you're part of Thermo Fisher Scientific, you'll do exciting work and be part of a team that values performance, quality, and innovation. As part of a su

Full-time

USD 103,100.00 - 154,700.00 per year

Product Development Engineer

Southington, Connecticut

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Today

Job Description: Our client, a leading medical device manufacturer, is seeking a Product Development Engineer to join their dynamic R&D team. This individual will play a critical role in the design, development, and validation of innovative medical devices that improve patient outcomes. The engineer will collaborate cross-functionally to translate user needs into design requirements, support prototype development, and ensure products meet all regulatory and quality standards. Responsibilities:

Full-time

Senior Engineer, Quality Assurance

Washington

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Today

Work Flexibility: Hybrid Senior Engineer, Quality Assurance Redmond, WA Join a team where your expertise directly impacts patient safety and product performance. As a Senior Quality Assurance Engineer, you'll lead critical investigations and drive improvements that shape the future of medical technology. This is a high-impact role for someone passionate about solving complex problems and ensuring quality excellence across the product lifecycle. Work Flexibility: Hybrid: Candidates must resid

Full-time

USD 88,800.00 - 142,300.00 per year

Staff Software Verification Engineer, R&D

Washington

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Today

Work Flexibility: Hybrid or Onsite As a Staff Software Verification Engineer you will collaborate with product development teams to coordinate software testing throughout the development lifecycle. Contribute to planning, execution, and documentation of test programs, ensuring compliance with Quality System requirements and best practices. Check out the product you'll support here: Stryker Emergency Care LIFEPAK 35 This role is hybrid expecting at least 3 days a week in the Redmond, WA office

Full-time

USD 115,600.00 - 190,400.00 per year

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