FDA Jobs in Minneapolis, MN

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W2 only Software Quality Assurance Consultant - EST/CST Only - regulatory affairs Medical Devices, software development life cycle risk management and configuration management FDA

APN Software Services, Inc

•

Remote

Contract

Please contact Abdul on "" OR email me at "" Job Responsibilities: Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements. 2. Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test pl
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Posted 6 days ago | Updated 1 day ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 58 days ago | Updated moments ago

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit Consulting

•

Remote

Contract

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Software Program Manager NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099) Candidate must be authorized to work in USA without requiring sponsorship Position: Medical Devices Software Program Manager(Job Id - # CFNJP00051124) Location: San Diego CA 92130 (Remote) Duration: 6 months + Contract to
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Posted 9 days ago | Updated moments ago

Sr. Engineer - Disposables R&D, Sustaining - Hybrid

VIVA USA INC

•

Plymouth, Minnesota, USA

Contract

Title: Sr. Engineer - Disposables R&D, Sustaining - Hybrid Mandatory skills: Medical Device, medical product development, Design for Six Sigma, CAD, PDM enterprise software, Creo, Solidworks, FDA Design Controls, ISO, Quality Management Systems, ANSI, AAMI, Risk Management, FMEA, Human Factors Engineering, statistical software, plastics materials, plastics processing, injection molding, extrusion, ultrasonic welding, UV, solvent bonding, sterilization, design changes, suppliers, materials, label
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Posted 30 days ago | Updated 24 days ago

Business Quality Assurance (BQA)

Activesoft, Inc.

•

Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)
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Posted 25 days ago | Updated 3 hours ago

PTC Arena Consultant

Teknikoz

•

Remote

Third Party, Contract

Key Responsibilities:Lead the technical delivery of PLM solutions using PTC Windchill and Arena PLM/QMS. Guide a team of engineers and consultants across India and the USA. Configure, customize, and maintain PLM modules such as BOM, Change Management, Document Control, and Lifecycle Management. Collaborate with business stakeholders to gather requirements and design scalable PLM workflows. Oversee PLM/ERP integrations and ensure data integrity across systems. Provide mentorship, code reviews, an
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Posted 23 hours ago | Updated 23 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

Maple Grove, Minnesota, USA

Full-time

Responsibilities: To ensure the quality of our client's software applications and equipment by validating/qualifying to specifications. Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations. Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCAD pplications, and system
Posted 22 days ago | Updated 7 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Maple Grove, Minnesota, USA

Full-time

Responsibilities: Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures. Provide project estimates independently. Review estimates for Engineer I's. Submit specification, protocol and report for approvals and documentation control vi Change Request. Develop
Posted 22 days ago | Updated 7 hours ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

•

Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot
Posted 22 days ago | Updated 7 hours ago

Sr. Engineer Disposables R&D, Sustaining

Katalyst Healthcares and Lifesciences

•

Plymouth, Minnesota, USA

Full-time

Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features, suppliers, materials, labeling, CAPA/Client, cost reduction, remediation). Identify, investigate, and solve engineering problems utilizing risk-based and customer focused app
Posted 20 days ago | Updated 7 hours ago

Principal R&D Engineer

Katalyst Healthcares and Lifesciences

•

Plymouth, Minnesota, USA

Full-time

Job Description: This section focuses on the main purpose of the job in one to four sentences. Leads design and development of product changes within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Schedule, budget, and lead engineering projects with minimal guidance. Serve as the technical expert for design
Posted 22 days ago | Updated 7 hours ago

Senior Sustaining Engineer

Stryker

•

Bloomington, Minnesota, USA

Full-time

Work Flexibility: Hybrid The Senior Sustaining Engineer will be responsible for the technical support and maintenance of the product and documents after its release, ensuring its continued operation and addressing any issues that arise throughout its lifecycle. Provide engineering expertise to cross-functional project teams.Support a portfolio of small to intermediate size sustaining engineering projects. Potentially lead smaller projects. Sustaining projects and activities typically originate
Posted 2 days ago | Updated 7 hours ago

Desktop Support

C4 Technical Services

•

Minneapolis, Minnesota, USA

Contract

Desktop Support Location: Aberdeen SD (Onsite) The analyst is responsible for the IT infrastructure at the site, and may be involved in workstation support, telecom, VOIP support, printers, server support and/or networking Skills: Ability to Configure, Deploy, Install, Migrate, Order, Patch, Replace, Support & Triage Site Infrastructure as follows:WINTEL/LINUX NetPC, Standard & Process PC'sHP & Manufacturing Printers (HP, Zebra, etc.)Telecom - Ethernet, LAN/WAN, Firewall, Routers and Switche
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Posted 44 days ago | Updated moments ago

Disposables R&D Engineer

Stefanini

•

Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring!Stefanini is looking for Disposables R&D Engineer for Plymouth, MN location (Hybrid Work)For quick Apply, please reach out to Ashish Gupta- / for W2 candidates only! **Workers can be remote/hybrid but must be local and able to come into the office at least three days a week** This section focuses on the main purpose of the job in one to four sentences.Leads design and development of product changes within sustaining engineering for disposable medical devices.Schedule,
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Posted 30 days ago | Updated moments ago

Full stack Engineer .NET ONLY W2

MSys Technologies - USA

•

Minneapolis, Minnesota, USA

Contract

We are looking for Fullstack Engineer .NET Position. Below is the Job Description, please have a look and if you are available for this position, please get back to me along with your updated resume in word format with contact number. Job Title: Fullstack Engineer .NET Job location: Hybrid (Minneapolis, MN) Duration: Long term Contract Job Description: We are looking for a Senior Full Stack Engineer with proven experience in modern web development using Angular (v14+), .NET 8, and Cosmos DB with
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Posted 9 days ago

Principal Engineer

Stefanini

•

Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring!Stefanini is looking for Principal Engineer for Plymouth, MN location (Hybrid Work)For quick Apply, please reach out to Gurvinder Singh Bali- / for W2 candidates only! **Workers can be remote/hybrid but must be local and able to come into the office at least three days a week** This section focuses on the main purpose of the job in one to four sentences.Leads design and development of product changes within sustaining engineering for disposable medical devices.Schedule
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Posted 30 days ago | Updated moments ago

.Net developer-Minneapolis, MN-3 days a week

Marlabs LLC

•

Minneapolis, Minnesota, USA

Contract, Third Party

Job Title: Senior full stack .Net Developer, Location: Minneapolis, MN 3 days in office mandatory. Duration: 6-12 months extendable Job Description: 10+ yrs experience is mandatory. About the Role: We are looking for a Senior Full Stack Engineer with proven experience in modern web development using Angular (v14+), .NET 8, and Cosmos DB with Azure cloud ecosystems. You will be working on a connected medical device platform that collects therapy data and transmits it to an Azure-based cloud por
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Posted 9 days ago | Updated 9 days ago

Senior Engineer

Katalyst Healthcares and Lifesciences

•

Plymouth, Minnesota, USA

Full-time

Job Description: You will be responsible for supporting the overall technical direction and work for Client Acute Therapies products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. You will review and approve design concepts/changes and provide general direction to technical staff, including ensuring that quality is built into the design during new product development and/or sustain
Posted 18 days ago | Updated 7 hours ago

Labeling Project Manager

Abbott Laboratories

•

Plymouth, Minnesota, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Yo
Posted 50 days ago | Updated 11 hours ago

Design/Process Engineer

Jobot

•

Saint Paul, Minnesota, USA

Full-time

Design/Process Engineer needed for leading Medical Device Manufacturer! This Jobot Job is hosted by: Jacob Hummel Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $80,000 - $150,000 per year A bit about us: Our organization is an ISO 13485:2016 certified and FDA-registered contract manufacturer specializing in custom plastic injection molding and assembly of medical devices. Our company offers comprehensive services from rapid prototyping to
Posted 2 days ago | Updated 4 hours ago