jobs in plymouth, mn, us

Plymouth, Minnesota

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3d ago

Roles & Responsibilities: Perform the activities associated with the systems engineering of one or more products in various stages of the product lifecycle from new product development to post-market surveillance Understand clinical and user needs and apply them to product realization Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc. Use knowledge of technology, process, and/or therapy domains to dr

Full-time

Sr. Industrial Engineer

Minneapolis, Minnesota

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3d ago

Primary Responsibilities: Operational Excellence Leadership Lead Lean and Six Sigma initiatives. Improve quality, cost, delivery, and manufacturing performance. Drive sustainable operational improvements. Process Improvement Identify manufacturing process inefficiencies. Reduce waste and non-value-added activities. Improve process capability and efficiency. Implement standardized work practices. Continuous Improvement Activities Conduct Value Stream Mapping sessions. Facilitate Kaizen workshops.

Full-time

CSV Validation Engineer

Plymouth, Minnesota

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3d ago

Summary: We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN. Roles & Responsibilities: Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports. Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports. Perform risk assessments, impact assessments, traceability, and change control activities. Support validation of GxP-regulated compu

Full-time

Mold Validation Engineer

Minneapolis, Minnesota

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3d ago

Primary Responsibilities: Executes mold trials (Functional Test, Gate Freeze, D3, Characterization) Captures RJG data & defines validated process windows Updates PODs & FW redlines Prepares draft OQ/PQ plans Coordinates daily with Healthcare ME, Ops, Quality, and Tooling pproves POD redlines & validation documents Ensures compliance with QMS & regulatory standards Run trials, collect RJG data, set process windows Prepare PODs, FW redlines, OQ/PQ drafts Coordinate with Healthcare teams Define mol

Full-time

Equipment Engineer

Minneapolis, Minnesota

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3d ago

Responsibilities: Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols specifically for blood glucose monitoring sensor manufacturing equipment. Define and document critical process parameters (CPPs) and equipment capabilities to ensure stable sensor performance within specification limits. Establish preventive maintenance plans, calibration schedules, and critical spare parts lists. uthor validation plans, validation protocols, test reports, includin

Full-time

Senior RAVE Clinical Database Programmer

Remote or New Jersey

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3d ago

Job Description: The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution. Key Responsibilities:

Full-time

Validation Engineer

Minneapolis, Minnesota

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3d ago

Job Summary: We are seeking an experienced Test/Validation Engineer with expertise in manufacturing validation, automated test equipment qualification, and Verification & Validation (V&V) within regulated industries. The ideal candidate will have hands-on experience in LabVIEW, NI Test Stand, IQ/OQ/PQ validation, functional testing, and preparation of validation documentation to support manufacturing equipment qualification and compliance. Roles & Responsibilities: Perform Installation Qualifi

Full-time

Senior Rave Clinical Database Programmer

Remote or New York, New York

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3d ago

Summary: The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution. Key Responsibilities: Serve as

Full-time

RWE Programmer (SAS)

Remote or New Jersey

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3d ago

Job Summary: We are seeking an experienced Real World Evidence (RWE) Programmer with strong SAS, SQL, and R programming expertise to support observational research and healthcare data analytics initiatives for pharmaceutical and biotechnology clients. The ideal candidate will have hands-on experience working with large-scale healthcare claims and Electronic Health Record (EHR) databases, developing patient cohorts, and creating high-quality analysis datasets for real-world evidence studies. This

Full-time

Senior SAS programmer (RWE)

Remote or New York, New York

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3d ago

Summary: The senior programmer position will be responsible for manipulating large databases and generating reports to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS and SQL programming skills and the ability to implement complex logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful eye for outliers and errors. Prior experience building patient cohorts and evaluating patien

Full-time

CQV Engineer

Remote or New Jersey

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3d ago

Summary : This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manuf

Full-time

Systems Engineer (medical devices)

Plymouth, Minnesota

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3d ago

Summary The Systems Engineer will support the overall technical direction of Acute Therapies products. This role involves contributing across the full product development lifecycle-from feasibility to post-market-focusing on requirements management, risk analysis, system integration, and verification/validation within a regulated medical device environment.Roles & Responsibilities: Support systems engineering activities across all product lifecycle stages (NPD to post-market) Translate clinical

Full-time

MODA Systems Analyst

Remote or New Jersey

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3d ago

Job Description: We are seeking a high-level Lab Systems Administrator for a fully remote position to execute administration, maintenance, and master data activities specifically for the MODA platform in support of the Massachusetts Biologics Operations (MBO) site. This role maintains system workflows, handles instrument interfaces, provides first-tier remote end-user support, and coordinates closely with Global system owners regarding system changes and communications. All requests, issues, and

Full-time

Medical Device V&V engineers

Remote or New Jersey

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3d ago

Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve

Full-time

Labeling Engineer

Minneapolis, Minnesota

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3d ago

Job Description: We are seeking a highly skilled and detail-oriented Medical Device Labeling Engineer with experience in onsite leadership and customer coordination to support global medical device programs. The ideal candidate will have 5-10 years of experience in medical device labeling, regulatory compliance (US and EU), and cross-functional project execution. In addition to core labeling engineering responsibilities, this role requires planning, coordination, and leadership of labeling imple

Full-time

Senior Automation Engineer

Remote or New Jersey

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3d ago

Roles & Responsibilities: Role requires a senior level automation engineer comfortable operating independently while supporting others. No CSV authorship responsibility: CSV activities are supported indirectly through automation execution and issue resolution. DeltaV DCS automation experience in pharmaceutical / biopharma manufacturing Strong troubleshooting and problem solving skills in live manufacturing environments, including commissioning, issue triage, and rapid resolution under GMP constr

Full-time

Verification Test Engineer

Chaska, Minnesota

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3d ago

Job Description: The Verification Test Engineer (Contract) will support verification activities for complex instrumentation systems. This role is responsible for instrument maintenance, execution of verification protocols, and configuration management of test instruments. The position requires hands on work in the lab and close collaboration with engineering, quality, and test method development teams. Roles & Responsibilities: Instrument Maintenance Perform routine maintenance, calibration, and

Full-time

Sterilization Engineer II

Remote or New Jersey

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3d ago

Summary: The Sterilization Engineer is responsible for intermediate activities related to Development Services product and process development, fabrication, and sterilization of materials as work order needs dictate. The ideal candidate should have 7+ years of relevant experience in sterilization engineering within pharmaceutical or medical device environments. Roles & Responsibilities: Turnover, controls, care, and custody from EPCM to client. Signature authority on equipment turnover. Fo

Full-time

Mechanical Engineer

Remote or New Jersey

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3d ago

Job Description: The successful candidate will be responsible for the design modification packages for mechanical systems and/or components for nuclear power plants. Requirements: Must have commercial nuclear and design modification package experience. Prefers candidates who have lead and driven the modification process. Bachelor of Science degree in Mechanical Engineering from ABET accredited school. 7-10+ years relevant work experience is considered necessary. Working knowledge of codes,

Full-time

AI Engineer - Clinical Data Science

Remote or New York, New York

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3d ago

Job Description: We are looking for an AI Engineer to join our Data Science team, building AI-powered solutions for clinical data processing and analysis within a major pharmaceutical organization. You will design, develop and deploy generative AI systems that automate clinical reporting workflows, extract intelligence from documents, and accelerate data-driven decision making. This is a hands-on engineering role - you'll be writing production code, not just building prototypes. Responsibilities

Full-time

jobs in Plymouth, MN, USA