Job Search Results for medical device regulations

We are seeking an experienced Operations Supervisor to oversee 75% of our operations lifecycle, including staging, filling, demolding, and other processes. This role will manage a team of 20... More employees across four departments, ensuring efficient and compliant operations.Key Responsibilities:Supervise and coordinate daily operations across staging, filling, demolding, and other processes.Manage and lead a team of 20 employees, providing guidance and support.Ensure compliance with Good Manufacturing Practices (GMP) and quality standards.Oversee safety documentation and ensure adherence to safety protocols.Conduct regular quality checks and audits to maintain high standards.Collaborate with other departments to optimize workflow and productivity.Implement process improvements to enhance efficiency and reduce costs.Required Qualifications:Bachelor's degree in a related field (e.g., Engineering, Manufacturing, Operations Management).Minimum of [X] years of experience in manufacturing, preferably in the medical device industry.Proven experience in safety documentation and familiarity with GMP.Strong leadership and team management skills.Excellent organizational and problem-solving abilities.Effective communication skills, both written and verbal.Preferred Qualifications:Experience with quality checks and audits in a manufacturing environment.Knowledge of regulatory requirements for medical device manufacturing.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

About the Role: We are seeking a highly skilled and experienced Quality Engineer to join our team in the medical device industry. The ideal candidate will have a strong manufacturing background and a... More proven track record in quality engineering, particularly in the assembly of complex, low-volume medical devices. This role involves close collaboration with various teams to ensure the highest standards of quality and regulatory compliance for post market hemostasis products.Key Responsibilities:Reviewing Engineering Change Orders: Evaluate and approve changes to engineering designs and processes, ensuring compliance with medical device regulations.Attending Standup Operation Meetings: Participate in daily standup meetings to discuss ongoing operations and project updates.Joining Change Review Meetings for Software: Collaborate with the software team to ensure hardware and software integration is seamless, focusing on medical device functionality.Design Change Risk Assessments: Conduct risk assessments for design changes to identify potential issues and mitigate risks, adhering to medical device standards.Supply Chain Issue Resolution: Assist procurement in identifying and resolving supply chain issues, including inventory management, with a focus on medical device components.Performing Supplier Audits: Conduct FDA audits and ensure suppliers meet regulatory standards specific to medical devices.Manufacturing Background: Work closely with assembly teams to ensure quality standards are met for medical devices.GD&T Knowledge: Apply Geometric Dimensioning and Tolerancing principles in quality assessments for medical device components.ISO 13485 Compliance: Utilize ISO 13485 standards in quality management processes for medical devices.Assessing Changes Against ISO 14971: Evaluate changes against ISO 14971 standards to ensure risk management compliance for medical devices.Supporting Hemostasis Product Lifecycle: Focus on maintaining and improving the quality of 'on market' hemostasis products, ensuring their sustainability and compliance.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

We are looking for a mid-level Embedded Software Test Engineer to join a close-knit test team at one of our largest medical device clients. These testers will be responsible for ensuring the quality,... More privacy, compatibility, and reliability of all medical devices. This candidate should be skilled with manual and automation testing, as well as writing and understand the test cases and stories, however a bulk of the work for this current project will be in manual testing. The ideal background will be with C/C++/C# languages. Day-to-day responsibilities are as followed:Develop and follow through with manual and automated test plans, test cases, and test scripts for embedded firmware in the medical industry.Collaborate with other teams involved in the SDLC to help drive streamlined solutionsPerform code reviews with focus on quality, FDA standards, compatibility, and security.Analyze test results and share with stakeholders to clearly describe results and provide recommendations, along with comprehensive documentation.Daily agile and SDLC responsibilitiesWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Insight Global is looking for a Quality Control Inspector for a medical device client in the Irvine, CA area. They will be responsible for in-line inspections, both top assemblies and finished goods.... More This position is for 1st shift (7am-3:30pm, Monday-Friday). They will then learn and be apart of receiving inspections once comfortable with training.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

An employer is looking for a Proposal Specialist/Business Representative to join their lab located in Midland, MI. This individual will join a team that writes proposals for chemistry focused studies... More for the following disciplines: consumer products, medical device, pharmaceuticals, specialty chemistry and bioanalytical. A request will come through the website/email and this person will meet with the client to gather specific specs that they are looking to uncover in the study. Then, you will either connect with the lab analyst to discuss how they would conduct the study or use your prior chemistry knowledge to write a proposal for how the study would be conducted. You will also include pricing in the proposal. Once the client accepts the proposal, the lab will begin working on the study. When the lab delivers the study to the client, you will be paid commission for the deal. You could work on anywhere from three to twelve proposals in a day depending on your experience level and the complexity of the proposal. We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Our client, an emerging leader in diabetes-focused medical device innovation, is seeking a Director of Mechanical Engineering to lead the design, development, and manufacturing support of durable,... More complex electromechanical systems. This is a rare opportunity to step into a high-impact leadership role where youll guide product development strategy while staying actively involved in design, prototyping, and hands-on problem solving. Youll manage a small, agile team through all phases of hardware developmentfrom early CAD and prototyping to testing, molding, and production. The right candidate is someone who thrives on taking ownership, bridging gaps between design and execution, and jumping in to resolve issues quickly and effectively. Youll collaborate closely with cross-functional teams across software, electrical, and manufacturing, and report directly to the VP of R&D. This is a unique chance to contribute at a formative stage of a fast-growing medtech companyworking alongside passionate, hands-on leaders to help shape the future of a life-changing product.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Overview:Were hiring two experienced Electrical Engineersone focused on Digital/FPGA design and one on Analog systemsfor a highly specialized team developing cutting-edge medical devices. The right... More candidates will have strong hands-on experience with PCB design, schematic capture, and component-level layout, including 0603-sized components. Youll work cross-functionally on full-cycle board development and testing.Qualifications: Bachelors degree in Electrical Engineering (required) 25+ years of experience in hands-on electrical hardware design Expert-level proficiency in Altium or ORCAD Experience working with 0603-size components Demonstrated experience designing boards with at least 4 layers Strong background in PCBA layout, design for manufacturability, and testingKey Responsibilities: Design and develop multi-layer PCBs (minimum 4 layers) using Altium or ORCAD Lead schematic capture, layout, and component selectionminimum 50 components per board Design with RF4 materials and 18 mil PCB thickness Execute and support PCBA layout and bring-up Collaborate with cross-functional teams to develop high-reliability boards for medical use Ensure robust documentation and adherence to design control processesRole-Specific Duties:Digital/FPGA Engineer: Develop and implement FPGA designs using Verilog or VHDL Write control logic from engineering drawings Strong background in digital controls and embedded hardware Hands-on with schematic entry and digital signal integrityAnalog Engineer: Design and test audio-level signal pathsfocused on performance and fidelity Evaluate frequency response and amplifier quality Design power supply circuits including DC-DC and boost converters Signal chain analysis and testing for human-body level applicationsWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Insight Global is looking for a Sr. Business Analyst to join a leading medical device manufacturing company within the PMO group. You will leverage Project Portfolio Management (PPM) tools and... More solutions to manage daily business operations, including financial support, project assistance, data analysis, and process improvement initiatives. Additionally, you will work closely with cross-functional teams to evaluate current processes and suggest new capabilities to boost the group's operational efficiency.Day to day you will be responsible for serving as the key point of contact for future training and support needs within the division by becoming an expert of the new PPM system. Lead and support the migration to this new Planisware-based PPM system. Collaborate with the Finance team to support the Annual Operating Plan, quarterly forecasts, cost center mapping, and monthly spending. Coordinate with internal and external tool developers to enhance current tools and implement new ones. Create and maintain portfolio analysis reports and dashboards using PPM/BI tools. Support the creation and closure of project codes. Develop training materials, templates, and best practices. Assist with ad-hoc requests and projects for the PMO team. Lead and support continuous improvement efforts for PPM tools, systems, and processes.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

The position is responsible for participating in the plants quality assurance program, ensuring that the medical device and processes meet quality control standards. Responsibilities include reading... More and comprehending instructions, following established procedures, selecting components according to specifications and required schedules, checking output to ensure the highest quality, maintaining equipment in good condition, keeping records of production quantities and time by recording all information on tracking sheets and in the database, reporting on issues, malfunctions, or defective parts, and performing other duties as requiredWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Insight Global is looking for a Lead NPI Engineer to travel 50% of the time to different manufacturing sites supporting the manufacturing and design transfer of medical devices. This person will be... More responsible for giving technical advise to manufacturing teams in the introduction of new medical products, as well as ensuring the adherence of regulatory standards, quality requirements and project timelines.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less