24 systems engineering jobs found in Maple Grove, MN

Quality Technician/Engineer Job Description: We are seeking a Quality Technician/Engineer to support the process development of tissue processing and implement quality inspections. The ideal candidate has hands-on experience with structural heart implants and quality inspection processes, and understands GMP requirements for the manufacture of a sterile medical device. Responsibilities: Execute lab-based process development runs in a laboratory setting to develop tissue processing of bovine pericardium. Implement quality controls during process development to ensure tissue performance, biocompatibility, and repeatability. Establish tissue-specific manufacturing procedures, inspection criteria, and in-process controls. Develop and maintain relationships with testing vendors for ongoing testing and process development characterization. Maintain test schedules and coordinate sample drop-off and pickup. Review technical documentation, such as...

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. Job Description Senior Project Manager, Clinical Evaluation The function of a Clinical Evaluation Report Project Manager supporting our Structural Heart Clinical Evaluation Products combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the European Commission Guidelines on Medical Devices: Clinical Evaluation : A Guide for Manufacturers and Notified Bodies under (MEDDEV 2.7/1 Rev 4) and EU Regulation 2017/745. The CER...

Job Title: Mechanical EngineerJob Description We are seeking a Mechanical Engineer with a strong background in new product development, particularly within regulated industries such as medical device design. This role requires a blend of technical expertise and project management skills to lead product design, development, and implementation efforts. Responsibilities Lead product design and development initiatives. Complete Design History File (DHF) document deliverables. Apply principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials. Design medical products and validate designs using methodologies and tools such as FEA, GD&T, and CFD. Collaborate with suppliers and manufacturing facilities to ensure designs are manufacturable. Identify and efficiently resolve technical problems and issues. Communicate effectively with clients for small scale programs. Research and analyze experimental data to...

Are you looking for an exciting job where you can put your skills and talents to work at a company you can feel proud to be a part of? Do you want a workplace that will challenge you and offer you opportunities to learn and grow? A position at Xcel Energy could be just what you’re looking for. Position Summary Standard Operations Position. Provide end-to-end project management, leadership and coordination for large complex projects or as a part of a transformational project work stream with responsibility for project scope, schedule, cost and risk management. Ensure alignment of financial and operational goals between projects and the business unit. Provide work team direction to achieve approved project scope, develop strategic sequencing and detailed milestone schedules, project-level cost tracking and reconciliation. Ensure availability or seek out adequate resources for projects. Essential Responsibilities Financial Management: Function as project controller....

Job Title: Controls Engineer Job Description We are seeking a Product & OEM Controls Engineer to bring leadership and technical expertise to our Product & OEM automation group. This role focuses on automation projects and customer service within the concrete industry, with minimal weekend travel. The candidate will design, install, and maintain PLC-based controls in a manufacturing setting. Responsibilities Design and engineer concrete batching control systems that integrate new and existing hardware/software for comprehensive operation. Program, configure, and troubleshoot Rockwell PLCs, Panelviews, VFDs, and industrial communication networks. Troubleshoot controls, instruments, and electrical issues impacting manufacturing processes. Perform on-site commissioning and provide training. Assist and train maintenance, production, and other technicians with technical or troubleshooting matters. Evaluate system equipment to optimize...

Quality Technician/Engineer Job Description: We are seeking a Quality Technician/Engineer to support the process development of tissue processing and implement quality inspections. The ideal candidate has hands-on experience with structural heart implants and quality inspection processes, and understands GMP requirements for the manufacture of a sterile medical device. Responsibilities: Execute lab-based process development runs in a laboratory setting to develop tissue processing of bovine pericardium. Implement quality controls during process development to ensure tissue performance, biocompatibility, and repeatability. Establish tissue-specific manufacturing procedures, inspection criteria, and in-process controls. Develop and maintain relationships with testing vendors for ongoing testing and process development characterization. Maintain test schedules and coordinate sample drop-off and pickup. Review technical documentation, such as...

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 Duties 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...

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...

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...

Seeking an OT Analyst to deploy asset inventory identification system to help understand deployed technologies in manufacturing. Defines operational technology systems and operational technology processes by using appropriate methods and tools. Partnering with business and manufacturing customers to understand requirements. Supports implementation of operational technology systems and processes by creating and communicating well-written documentation and presentations. Developing and executing test specifications, and implementing project and quality plans, while working with quality assurance analysts to improve quality processes. Creates and provides training material for user assistance and system usage. Resolves issues related to manufacturing use of implemented systems or processes by working with systems or manufacturing owners to find acceptable solutions. May support multiple project activities simultaneously, working with internal and external cross-functional groups....

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...

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...

Senior Regulatory Affairs Specialist Date: Jan 9, 2026 Location: Maple Grove, MN, US Company: Teleflex Expected Travel : Up to 10% Requisition ID :13226 About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit...

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. SUMMARY This position is responsible for performing and maintaining certification of 0-5 functions of cleaning, inspecting, identifying, function testing, packaging and sealing medical devices. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Chemically clean and reprocess medical devices Functional Testing with electronic...

Job Description: This position offers the opportunity to support process development and product commercialization throughout the global plant network. You will work cross-functionally to lead process development of complex technologies on new products, drive new business activities, and ensure efficient and effective transfer of products into production. This role is ideal for a highly motivated individual who can solve complex technical problems both independently and in a team setting. The environment is fast-paced and will require collaboration across multiple functions within a global company. Your technical skills, passion for innovation, and continuous improvement will be key in driving growth through efficient commercialization of new products. Responsibilities: Partner with R&D to develop design specifications, draft test methods, and drive material selection. Provide Design for Manufacturability (DFM) input to the engineering print package....

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. SUMMARY This position is responsible for performing and maintaining certification of 0-5 functions of cleaning, inspecting, identifying, function testing, packaging and sealing medical devices. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Chemically clean and reprocess medical devices Functional Testing with electronic test...

Job Description: The Quality Engineer is responsible for developing new processes and products, validating new equipment and technology, assisting production with continuous improvement on the shop floor, managing customer complaints, and handling CAPA/NCR activities. This role also involves leading change requests with customers and ensuring compliance with ISO, FDA, and other applicable standards. The Quality Engineer collaborates closely with QA Technicians and Quality Inspectors (QAR). Responsibilities: Develop new processes and products and revise existing ones. Create and update project-specific quality plans, ensuring adherence to customer requirements. Work as part of a cross-functional team to develop methods to measure products to ensure they meet quality standards. Troubleshoot measurement methods and equipment to ensure accuracy and reliability. Lead validation of new products and technology (IQ, OQ, PQ) and act as QA lead for...

Job Description The Packaging Engineer is responsible for packaging engineering activities with specific areas of responsibility including providing technical expertise and support for packaging design activities, material/component selection, maintaining specifications, artwork/labeling design, and packaging equipment design, troubleshooting, and optimization. Responsibilities Collaborate with external artwork suppliers, printers, packaging component suppliers, contracted customers, and internal partners during artwork and package generation to select packaging components, define equipment needs/constraints, provide suggestions on potential cost savings, and optimize packaging design. Develop and maintain die lines and inspection plans for printed components. Update and approve labeling specifications. Develop, document, and manage packaging specifications and standards for packaging materials such as bottles, cartons, shippers, foils, and films. Update...

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,...