18 engineering software jobs found in Maple Grove

Design Quality Engineer Job Description: The Design Quality Engineer leads design control efforts to develop new and improve existing medical devices. This role involves close collaboration with various functions, including R&D and Product Development core teams, to ensure appropriate design controls are established and achievable. Additionally, the position supports process development, manufacturing-related design changes, maintaining regulatory compliance, manufacturability improvements, and cost reduction efforts. Responsibilities: Own the creation and implementation of all design control deliverables. Lead on-time Design Verification and Design Validation and support Process Validation IQ/OQ/PQ/PPQ planning and execution. Actively participate in and contribute to core team and customer-facing meetings. Drive the meaningful translation of user requirements into discrete, objective, measurable, verifiable, and traceable product requirements....

Packaging/Labeling Engineer Job Description: This position serves as the packaging and labeling subject matter expert responsible for defining, designing, verifying, and documenting all packaging and labeling solutions for a complex medical device system, including capital equipment, reusables, disposables, and multi-component kits. This role requires a high level of autonomy, technical depth, and familiarity with medical device regulatory requirements. Responsibilities: Serve as the sole subject matter expert for packaging design across capital, reusable, disposable, and kit-based device configurations. Develop protective packaging solutions in compliance with applicable packaging, distribution, and sterilization standards. Create packaging specifications, drawings, CAD models, and BOMs for all packaging components. Select materials and evaluate designs based on performance, manufacturability, and cost. Integrate packaging with sterilization,...

Job Title: Manufacturing Engineer IVJob Description As a Manufacturing Engineer IV, you will lead clinical build lines and manage process development deliverables, such as process validation documentation. This role supports commercialization activities and requires onsite presence. Responsibilities Work cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success. Consistently generate innovative and unique solutions to meet department goals. Complete complex engineering work and contribute to new product development teams and product support, including technology development, test of materials or products, preparation of specifications, Six Sigma process study, process improvements, and report preparation. Select process improvement techniques to solve complex problems and make sound equipment and process recommendations. Summarize, analyze, and...

Job Description Insight Global is seeking a Software Engineer to join on of our medical device clients R&D team working an intravascular ultrasound imaging system that helps identify blockages in the heart. The team is enhancing the product with machine learning to make ultrasonic images easier to interpret. You'll be part of a 5-person project team (within a broader group of 20), collaborating closely with a software lead in an agile environment. This is a hands-on, mid-to-senior role. Key Responsibilities Design, develop, and ship Windows desktop applications in C#/.NET with WPF for a regulated medical imaging product. Implement features and UI components that support product imaging workflows; contribute 50-70% of your time to hands-on coding. Apply imaging and machine learning techniques to improve ultrasound image interpretation. Author and maintain documentation aligned to IEC 62304 (software life-cycle standard) and meet internal SDLC...

Job Description Insight Global is seeking a Software Engineer to join on of our medical device clients R&D team working an intravascular ultrasound imaging system that helps identify blockages in the heart. The team is enhancing the product with machine learning to make ultrasonic images easier to interpret. You'll be part of a 5-person project team (within a broader group of 20), collaborating closely with a software lead in an agile environment. This is a hands-on, mid-to-senior role. Key Responsibilities Design, develop, and ship Windows desktop applications in C#/.NET with WPF for a regulated medical imaging product. Implement features and UI components that support product imaging workflows; contribute 50-70% of your time to hands-on coding. Apply imaging and machine learning techniques to improve ultrasound image interpretation. Author and maintain documentation aligned to IEC 62304 (software life-cycle standard) and meet internal SDLC...

This is an opportunity for a Software Controls Engineer to be part of a team that designs custom equipment/software solutions for R&D, process development and manufacturing needs. Use your knowledge and passion for automation, manufacturing, and medical devices to help shape the needs of company and the medical device industry. As a Software Controls Engineer, you will be part of an on-site team of talented engineers and automation specialists who create and support automated solutions for our manufacturing and new product development customers. You will support the development, implementation, and support of automated equipment and software systems for medical device manufacturing. This role has a hands-on approach in equipment development including automation and controls design, electro-mechanical systems, industrial and collaborative robots, and computer hardware and software support. This enables us to support and develop a wide range of legacy and new technology...

The Senior Mechanical Engineer will select technologies, methodologies and define requirements for individual projects; research and analyze data such as experimental data, customer design proposals, specifications, and documentation; direct and coordinate actions from product conception through design transfer to ensure products and systems conform to engineering design, standards and customer specifications; resolve technical issues and problems; effectively communicate their work and status; and delegate work and leverage engineering technicians and designers. Responsibilities: Apply principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials. Design medical products and confirms correctness using methodologies and tools such as FEA, GD&T, CFD, etc. Evaluate mechanical and electromechanical systems and products by designing and conducting research programs. Lead and complete medical standard document deliverables. Identify and efficiently resolve...

Summary: This Design Engineering position will report to the R&D Engineering Manager and provide support to the design and upkeep of drug / device combination products. The desired candidate will possess a strong emphasis in mechanical design with expertise in design controls and design validation; excellent cross functional team interaction; initiative and drive to meet goals on time. Project Details: Able to support changes to existing device products following design control procedures Generate test reports that are clear in hypothesis, procedure and conclusion Find innovative solutions to technical problems Job Experience: One to two years overall engineering experience. Medical device experience a plus. Hourly Rate: 51-66 Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected...

The Senior Electrical Engineer will be responsible for the development of new products, including electronic architecture design, detailed circuit design and analysis, prototyping, implementing designs, test, and discovering innovative solutions to complex problems and systems. Primary Responsibilities: Performs detailed electronic designs for electronic components, products, or systems for commercial, industrial, medical, military, or scientific applications. Analyzes customer needs and determines electrical system requirements and cost to develop a system plan. Ability to evaluate current systems/processes to recommend design modifications or equipment repair/updates. Develop testing procedures for electronic components and equipment; includes leading and supporting prototype build and test activities. Writes technical documents such as design specifications, verification test plans and reports. Plans and develops applications and modifications for electronic properties used in...

Seeking a talented Principal Electrical Engineer to join our innovative team. As a Principal Electrical Engineer, you will play a critical role in the design, development, and testing of electrical and electronic systems for medical devices. You will work collaboratively within a multidisciplinary engineering team and engage directly with clients to ensure product excellence and compliance with regulatory standards. DUTIES AND RESPONSIBILITIES: Lead and manage the design and implementation of complex electronic systems. Oversee and mentor junior engineers and technical staff. Collaborate with cross-functional teams to define product requirements and specifications. Conduct analysis of electrical systems, creating schematics and detailed technical documentation. Implement testing protocols to verify adherence to performance and functional criteria. Resolve technical challenges and perform root cause analysis on issues that arise. Act as the primary technical interface with...

Summary: The Process Development Engineer is responsible for developing processes to scale up from R&D formulation, optimize process flow, reduce variability within the process, improve operating capabilities, and help product safety. Their main objective is to identify, develop, verify, validate, and transfer ownership processes/products from their early developmental stages, product trials, to manufacturing operations. Additionally, a process development engineer evaluates and analyzes current processes and provides recommendations for process improvements as needed. Project Details: Project a professional image and organized working environment Work closely with R&D Technologists, R&D Technicians, and engineering on new products and processes Responsible for the transfer of new products and processes from innovation stage to commercial production, including lab scale ups and plant trials Develop processes for operations to ensure new products are manufactured...

Job Description The role of Supplier Quality Engineer is to drive exceptional product quality for customer value beyond expectations while ensuring regulatory assurance and optimized cost quality. Through effective and accurate supplier quality processes, this position ensures product quality, cost-effectiveness, and safe and efficient equipment operation. Responsibilities Develop and manage supplier quality plans through appropriate risk analysis. Support ISO 9000 Quality Process Requirements. Support implementation of initiatives related to supplier processes and improvements. Ensure Corrective and Preventive Action plans are developed and executed at assigned suppliers. Evaluate the need for quality data/reports and provide required quality information beneficial to the specified processes. Perform supplier quality audits as required by the verification plan or by the Quality Manager. Identify non-conforming materials and...

Job Title: Senior Quality EngineerJob Description The Senior Manufacturing Quality Engineer is a key member of our innovative team working on cutting-edge technologies in the field of cardiology. The primary responsibility of this role is to ensure the design assurance of a heart valve and a delivery catheter system. This position requires a background in the medical device industry, particularly in cardiological devices, including implantable heart valves and transcatheter delivery systems, along with a strong understanding of regulations and standards such as 21 CFR 820. Responsibilities Lead the product development process including key design assurance activities, design reviews, verification and validation activities, development and validation of testing methods, management of product requirements, test case tracing, and risk management. Facilitate the transition of new product development into production. Conduct reviews and enhancements of Quality...

Job Description The Process Engineer II will play a key role in supporting process development and product commercialization across the organization's global plant network. Working in a fast-paced, cross-functional environment, this individual will partner with R&D to define design specifications, develop test methods, and drive material selection while providing Design for Manufacturability input. Responsibilities include innovating and implementing new processes, tooling, and automation; overseeing prototype and initial production builds; authoring and reviewing validation protocols; and ensuring compliance with quality system requirements. The role requires strong engineering fundamentals, problem-solving skills, and the ability to collaborate across functions to deliver efficient product transfers into production. Preferred candidates will bring experience with extrusion processes, polymers, equipment development, DFSS tools, and regulated industry practices, along with...

R&D Test Technician Job Description: The R&D Test Technician will support the engineering team in the hands-on build, assembly, testing, and troubleshooting of medical devices and associated fixtures. This role is critical to ensuring high-quality prototype builds, precise test execution, and reliable documentation in support of design verification, process validation, and product development activities. The ideal candidate is an experienced, detail-oriented technician who is comfortable working in a regulated medical device environment and can collaborate effectively with engineers, quality professionals, and manufacturing teams. Responsibilities: Build and assemble medical devices and associated fixtures. Perform testing and troubleshooting of prototypes. Ensure high-quality prototype builds and precise test execution. Document and support design verification and process validation activities. Collaborate with engineers, quality...

The Equipment Engineering (EE) Project Manager supports product development programs and Operations projects. In addition, EE Project Management leads teams and coordinates deliverables across EE functions to provide quality solutions on time and within budget. The EE Project Manager has operations and/or process development expertise, and the potential ability to lead a team of representatives from multiple Operations/Process development functions. Your Responsibilities Include: Must have demonstrated strong leadership capabilities across multiple functions, an excellent ability to communicate at many levels and an ability to quickly and effectively form strong cross-functional working relationships. Works cross functionally to influence, coordinate and drive activities related to Equipment Engineering deliverables. Participates on cross functional project teams to develop clear specifications, influence project direction, evaluates feasibility of concepts through prototyping...

Job Title: Mechanical DesignerJob Description As a Mechanical Designer, you will be responsible for the layout and design of mechanical parts and systems using 3D Computer-Aided Design (CAD). You will need to understand how designs are applied, interact with other assemblies, and how they will be manufactured. Additionally, you will use engineering calculations, Finite Element Analysis (FEA), and other software tools to prepare and compile necessary calculations to support product designs. You will generate engineering release documentation and verify its accuracy against applicable rules and standards. Your role will also involve determining the feasibility of modifying existing or designing new equipment, considering cost, time limitations, and other technical and economic factors. Furthermore, you will analyze product or equipment specifications and performance requirements to determine possible design improvements. Responsibilities Design mechanical parts and...

Summary: Perform tactical work and review a variety of documents, protocols, and reports. Project Details: Exhibit varying levels of experience and a solid progression of work and/or training Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies Review and approve manufacturing records, change controls, investigations and analytical data Review and approve test methods and method validations Review manufacturing validation protocol and reports Job Experience: Experience in small molecule manufacturing and contract manufacturing Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline A minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical company Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc. Excellent verbal and written communication...