FDA Jobs in Minneapolis, MN

1 - 20 of 93 Jobs

Senior Regulatory Affairs SpecialistJob Title - Senior Regulatory Affairs Specialist

Sunrise Systems, Inc.Company Name - Sunrise Systems, Inc.

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Chaska, Minnesota, USA

Contract

Our client, a leading medical devices manufacturing company, is looking for a Senior Regulatory Affairs Specialist. This is for an initial duration of 18 months and is located in Chaska, MN. Job Type: Contract (Candidates must be able to work on W2 without VISA sponsorship) 3 must haves: Experience with design changes, demonstrated RA leadership on high visibility core team, IVDR or EMDR experience Job Description: The Senior Specialist Regulatory Affairs is an individual contributor and subject

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)Job Title - Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

JobotCompany Name - Jobot

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Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Design/Build Solutions to meet our Clients

Quality EngineerJob Title - Quality Engineer

Talent Software Services, IncCompany Name - Talent Software Services, Inc

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Maple Grove, Minnesota, USA

Contract

Quality Engineer IIJob Summary: Talent Software Services is in search of a Quality Engineer for a contract position in Maple Grove, MN. The opportunity will be seven months with a strong chance for a long-term extension.Position Summary: Develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)Job Title - Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

JobotCompany Name - Jobot

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Full-time

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)Job Title - Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

JobotCompany Name - Jobot

•

Full-time

Sr Mechanical/Process Design Engineer - Technical Lead (Cleanrooms/Pharma/Healthcare/cGMP) - Remote (East Coast Preferred) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Des

SAP PP/PM ConsultantJob Title - SAP PP/PM Consultant

Innova Solutions, IncCompany Name - Innova Solutions, Inc

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Saint Paul, Minnesota, USA

Contract

Innova Solutions is immediately hiring for a SAP PP/PM Consultant. Position type: Full-time Contract Duration: 6+ Months Location: St. Paul, MN 55144 (Hybrid Role- 3 days in office) As a(n) SAP PP/PM Consultant, you will: Experience: 10+ years Job Summary: Seeking a highly experienced SAP PP/PM implementation specialist with deep domain expertise in pharmaceutical manufacturing and equipment maintenance.The consultant will lead comprehensive manufacturing implementations, bringing extensive kno

IBM Maximo EAM SpecialistJob Title - IBM Maximo EAM Specialist

Transcend IT SolutionsCompany Name - Transcend IT Solutions

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Remote

Contract, Third Party

Position Title: IBM Maximo EAM Specialist Location: 100% Remote (East Coast is preferred,Duration: 6+ Months Job Details:MUST HAVE PAST THERMO FISHER EXPERIENCE! Maximo Experience is not the only key skill sets for the positions. Experience in Pharma/ Bio Tech is a MUST Maximo Life Science Industry Solution ExpertiseFDA regulatory experiencePharma validation, change managed, calibration data sheets for life sciencesSignature reference using FDA guidelinesGMP experienceTFS key application experie

Business AnalystJob Title - Business Analyst

NTT DATA Americas, IncCompany Name - NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil

LIMS and QC Applications ConsultantJob Title - LIMS and QC Applications Consultant

Expedite Technology SolutionsCompany Name - Expedite Technology Solutions

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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

Principal Engineer - Disposables R&D, SustainingJob Title - Principal Engineer - Disposables R&D, Sustaining

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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. Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets. Manage change controls from initiation through execution. Lead the creation and maintenance of design history files. Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders. Sche

Engineer Disposables and SustainingJob Title - Engineer Disposables and Sustaining

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Responsibilities: Create new 3rd party supplier documentation including design specifications, labelling, design drawings, etc. for peritoneal dialysis disposable sets. Create, modify, and maintain design history files. Perform change control assessments. Work closely with project manager and technical lead to achieve project commitments. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. Requirements:

Clinical SAS ProgrammerJob Title - Clinical SAS Programmer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Minneapolis, Minnesota, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures, and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.

R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MNJob Title - R&D Engineer Sustaining, Medical Devices (Disposables) - Plymouth, MN

Cube Hub, Inc.Company Name - Cube Hub, Inc.

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Plymouth, Minnesota, USA

Contract

Job Title: Principal R&D Engineer Sustaining, Medical Devices (Disposables) **Workers can be remote/hybrid but must be local and able to come into the office at least three days a week** Job Location: Plymouth, MN Job Duration: 12 months Summary: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. Essential Duties and Responsibilities: This section contains a list of prima

Principal EngineerJob Title - Principal Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Job Description: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure 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. Manage a new 3rd-party supplier documentation strategy for peritoneal dialysis disposable sets. Manage change controls from init

Development Process EngineerJob Title - Development Process Engineer

ExperisCompany Name - Experis

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Saint Paul, Minnesota, USA

Full-time

Title: Development Process Engineer Location: St. Paul, MN (100% Onsite) Duration: 12 Months Pay Range : $30/hr to $33/hr (On W2) We are looking for a "Development Process Engineer" to join one of our Fortune 500 clients. Job Responsibilities: Establish processes based on product specifications, evaluate process and design alternatives based on Design for Manufacturability principles Understand principles of Cost of Goods Sold, manage program compliance with Quality Control requirements (i.e.

Engineer Disposables R&D, SustainingJob Title - Engineer Disposables R&D, Sustaining

StefaniniCompany Name - Stefanini

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Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Vipul Bhardwaj - call: / email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets.Create, modify, and maintain design history files.Perform change control assessments.

Principal Engineer Disposables R&D, SustainingJob Title - Principal Engineer Disposables R&D, Sustaining

StefaniniCompany Name - Stefanini

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Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Principal Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Tuhin Podder- call: /email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Technical lead for DHF structure within sustaining engineering for disposable medical devices.Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.Manage change controls from initiation th

Validation Engineer IIIJob Title - Validation Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Engineer Disposables and SustainingJob Title - Engineer Disposables and Sustaining

Rose InternationalCompany Name - Rose International

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Plymouth, Minnesota, USA

Full-time

Date Posted: 07/11/2025 Hiring Organization: Rose International Position Number: 485371 Industry: Healthcare Job Title: Engineer Disposables and Sustaining Job Location: Plymouth, MN, USA, 55441 Work Model: Onsite Employment Type: Temp to Hire FT/PT: Full-Time Estimated Duration (In months): 12 Min Hourly Rate($): 30.00 Max Hourly Rate($): 35.00 Must Have Skills/Attributes: Creo, DFMEA, Medical device, Sterilization Experience Desired: Experience in Class II or Class disposables medica

Senior EngineerJob Title - Senior Engineer

ExperisCompany Name - Experis

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Plymouth, Minnesota, USA

Full-time

Our client, a leader in the medical device industry, is seeking a Senior Engineer to join their team. As a Senior Engineer, you will be part of the engineering department supporting critical projects that enhance patient care. The ideal candidate will have strong collaboration skills, a keen attention to detail, and a proactive approach to problem-solving, which will align successfully in the organization. Job Title: Senior Engineer Location: Plymouth, MN (Hybrid - onsite 3 days a week) Pay Rang