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

Insight Global is looking to hire Service Desk Consultants for a large healthcare client transitioning from legacy systems to the new province-wide Oracle Health CIS (Cerner Millennium).The primary... More responsibilities will include providing tier 2 telephone or computer support to healthcare operations centers, providers, and clinicians specifically operating bedside medical devices (Anesthesia units, Fetal Monitoring systems, Infusion Management, Patient Monitors, Renal dialysis, Ventilators). Medical devices are used by clinicians in the support of patient care. Medical device interoperability enables clinicians to improve patient care by connecting and integrating medical devices that can share patient data with the Clinical Information System (CIS). Integrating medical devices will improve clinical workflow, data quality, and enhance clinical decision support and patient safety.Bedside Medical Device Integration, or BMDI, facilitates connectivity of bedside medical devices to the CIS, allowing the automatic upload of patient data from bedside medical devices (equipment attached to a patient, such as physiological monitors, anesthesia machines, fetal monitors) directly into the electronic patient record within the CIS.The benefits include timely access to realtime data; improved accuracy of data; improved clinical decisionmaking; reduced duplication of data; ability to trend and monitor patients remotely; reduced paper charting and associated costs (storage and scanning); and safer patient transitions.The support consultants will respond to internal full-time employees and clinicians using various devices, handling an estimated volume of 10-30 tickets daily. You will support medical device integration using IBUS (CareAware) software and possess strong knowledge of IT infrastructure. Each team member should be very resolution focused, offering a complete solution to any internal stakeholder with white glove service and professional follow-up. Each Support Consultant will also be trained on the complex, multiple systems that are used but should feel confident in their ability to adopt new software quickly. The candidates joining the team will receive thorough training and development so it's essential that each person is committed to the duration of the contract and eager to join a growing team and a fast moving project.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 seeking a highly skilled and execution-focused Product Manager to join our team in the medical device space. This role is ideal for someone with a strong background in hardware product... More development, particularly with COTS (Commercial Off-The-Shelf) components and customization, and a proven track record of commercial product launches. You will play a critical role in driving product execution, ensuring compliance with quality systems, and delivering innovative solutions to market on time.Key Responsibilities Lead the end-to-end product lifecycle from concept through commercialization for hardware-based medical devices. Collaborate cross-functionally with engineering, quality, regulatory, and marketing teams to ensure successful product development and launch. Translate customer and market needs into clear product requirements and roadmaps. Manage timelines, deliverables, and resources to meet aggressive deadlines. Ensure all product development activities comply with Quality Management System (QMS) standards and regulatory requirements. Work closely with hardware engineering teams to guide technical decisions and resolve issues. Rapidly ramp up on new technologies and product lines to contribute immediately to ongoing initiatives.Compensation:$60/hr to $ 75/hr Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401K retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.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 seeking a Remote Technical Writer to join their Digital Transformation team working in the east coast time zone. The technical writer will be joining a leader in the medical device... More industry and their primary responsibility will be for the development of new and revised Standard Operating Procedures (SOP), Work Instructions, & Computer System Validation (CSV) Test Scripts. The Goal of this project is to deploy new digital capabilities to enable automation of product release processes. This remote technical writer will ideally have medical device industry knowledge and be able to work in both the English and Spanish languages. Other daily responsibilities will include: support training materials development and deployment, support draft of User Acceptance Test scripts, manage change control process in PLM system for all documentation, track progress and report task statusWe 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

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

One of our large Life Sciences clients is looking for a motivated individual with 3D printing experience and experience with methods such as injection molding, stamping, and machining to join their... More team. This role is ideal for someone who enjoys working in a dynamic lab and interacting with several different stakeholders to make their protype ideas come to life. They are supporting R&D and are interacting with several lab and engineering teams on a daily basis. They are working to problem solve and troubleshoot these ideas and must be mechanically inclined. They will be working with 5-10 different types of laser printers and are helping dictate location of supplies, resources, etc. for people to work on their projects and that they are maintained and inventory is ordered.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

Duties and Responsibilities include the below but are not limited to, as your manager may ask you to perform tasks outside of normal job description.Works independently with general instruction and... More broad work expectations. Configures the VIPER software specific to customer needs and/or Spectrum Medical goals. Configures Live Vue and collaborates with field clinical sales team optimize Informatics build. Works with other Spectrum Depts. on the development of IFUs, training materials, etc. for customer use. Travel to customer sites for implementations, training and/or support. Extended and overnight stays may be necessary. Assists and/or completes device connectivity and aids in whatever manner required for customer implementations. Assists with validation of software. Assists and tests customer settings before, during and after software updates. Provides customer support via phone, email and/or text to aid customers in troubleshooting and/or improving their experience and utilization of Spectrum software. Coordinate with other Spectrum Depts. to be sure any customer issues are reported and documented in compliance with Spectrum Quality Processes (SOP).Organizes and prioritizes tasks and meets deadlines. Coordinates training and meeting schedules. Takes ownership of trouble shooting and customer service to Users, advising on the clinical and technical use of Quantum Informatics, to include the Customer Support Line and associated documentation.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