Job Search Results for medical device

Job Summary:Driven by our purpose to enable healthier lives everywhere, every day, we are seeking a talented and experienced Electrical Engineer to join a growing R&D department in our Surgical... More Division to contribute to new product development of both Capital and Disposable products. Our team is customer focused, working to enhance the user's experience through improving our system's performance, compliance and reliability through state of art hardware design and selection, robust testing, and analysis. In this role you will have the opportunity of working cross functionally with groups such as Quality, Regulatory, and Manufacturing as part of the development cycle.The Lead Electrical Engineer, NPD, delivers value by driving the design and selection of HW that meets the needs of both the customer and the business. This role will be responsible for prototyping, analyzing, and documenting design concepts throughout the NPD cycle. As such, this role requires robust familiarity with design and troubleshooting tools. This role will also support senior level EEs in the design and development of PCBs for control of various subsystems within our capital portfolio. As such, this role will be a champion for state-of-art design practices, including robust design reviews. The Lead Electrical Engineer has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Determines methods and procedures on new assignments and coordinate activities of other personnel as a Team Lead.Essential Duties and Responsibilities: ?Functions as a technical lead for the electrical engineering discipline and can effectively coordinate and contribute to simultaneous programs or projects of varying sizes. ?Participates in product and cross functional product and project teams. ?Represents Electrical Engineering and department culture through example, leadership and excellent communication skills. ?Owns architectural specifications of electrical and electronic systems and subsystems for medical device development. ?Performs and guides lower-level engineers in electrical design, design reviews, and design for manufacturability.?Specifies, evaluates, and selects electronic and electro-mechanical components to meet product specifications. ?Leads design responsibilities such as design, analysis or trouble shooting of printed circuit assemblies, cable and harnessing design, power conversion circuits, analog conversion, filtering circuits, power distribution, and developing CAD schematics for electrical assembly or PCB design. ?Develops, builds, and maintains electrical test fixtures, test control apparatus and equipment to support the development process.?Develops methods of verification of electrical components, PCBs, and subsystems.?Drives a culture of continuous learning and improvement. Champions opportunities to introduce new technologies, systems, methods, and controls and deliver design, quality, cost or time-to-market improvements. ?Works with contract manufacturers and vendors/suppliers to ensure device design and parts meet functionality and medical device quality and regulatory standards. ?Establishes collaborative relationships with all stakeholders within the division and create links with experts within the Hologic network and outside.?Stays current with emerging technologies and processes to support ongoing innovation. ?Trains and mentors lower-level engineers to further develop and impact the organization. Compensation: $150,000 to $170,000. Exact compensation may vary based on several factors, including skills, experience, and education.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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

A large medical device company in Irvine, CA is looking for a Product Stewardship Engineer to support material compliance and regulatory activities for critical care medical devices. This individual... More will support product stewardship efforts across the product lifecycle, including material compliance, restricted substance tracking, BOM review, and regulatory documentation. The role will work closely with R&D, Engineering, Quality, Regulatory, and Supply Chain teams to ensure products meet global material and environmental regulations.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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 seeking an experienced, highly skilled Quality Engineer to support an established medical supply client out of Chicago, IL. The Quality Engineer will provide cross-divisional... More support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR?s, product specifications, design control files, and CE technical files.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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's customer is seeking a mid-level Test Engineer to join a growing team responsible for testing software that controls robotic medical devices in Durham, NC. This role will require... More coming onsite 2-3 days each week.This role was created to support new projects and reduce current testing bottlenecks as development efforts continue to scale. You?ll work closely with software engineers and QA leadership to ensure high-quality, reliable software in a highly regulated, patient-impacting environment. The work is hands-on and detail-oriented, combining manual testing, system setup, and physical device interaction, with a gradual transition toward test automation.Responsibilities:? Develop detailed test plans, scenarios, and scripts.? Execute, analyze, and document test results.? Troubleshoot issues and collaborate with developers on corrective actions.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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

? Manage RST RPM/E (release project management/engineering) portfolio CAPAs, ensuring triage, prioritization, timelines, and escalation? Implement and maintain a CAPA tracking workflow? Monitor due... More dates, milestones, and provide weekly/monthly reporting? Forecast resources and funding for CAPA investigations? Identify emerging risks or future CAPAs using metrics, audits, and trend signals? Support project planning, scheduling, risk management, and communication? Participate in SAFe ceremonies, reporting, and continuous improvement efforts? Partner cross-functionally with Quality, RPE Product Engineering, RPE ITI, and Scrum teamsInsight Global is seeking a CAPA Program Manager to support a top medical device client within their RST RPM/E organization. This consultant will manage and mature the CAPA process across multiple value streams, ensuring efficient intake, tracking, reporting, and cross-functional alignment. The ideal candidate brings medical device CAPA experience, strong project management capabilities, exceptional attention to detail, and comfort working within Agile (preferably SAFe) environments. This role is highly visible, working closely with engineering, quality, and leadership teams to drive quality execution and continuous improvement initiatives.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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 Field Data Engineer for a long term opportunity in the Cincinnati, OH area. This Data Engineer will be tied to multiple NPD projects for a medical device leader and will... More report into the Data Lead over the program. The Field Data Engineer will be required to establish consistency, structure, and scalability across how data is collected, stored, processed, and prepared for deeper analytics. This individual will own the end-to-end data lifecycle for field and test data, driving standardization and enabling reliable downstream analysis. While this is an individual contributor role, it requires strong leadership, initiative, and the ability to independently prioritize work across multiple stakeholders as the stakeholders they will be working with are mechanical and test engineers. Ideally someone with 2+ years in a testing role will be the correct fit for this role. The main responsibilities will include:Data Collection - establish and enforce data collection norms, streamline existing collection processes and participate in data collection. This will be performed utilizing python, git, SQL or other data engineering toolsData Storage: compile, clean, organize, and develop data pipelines and database schemas coming from ~10 collective test stands, including offline equipment. They will also support data transfers via USB and other offline methods, ensuring integrity and traceabilityWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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 seeking a Manufacturing / Validation Engineer to support a top medical device manufacturing client in Raynham, MA. This individual will play a critical role in the launch of a new... More production line, supporting the installation, commissioning, and qualification of new manufacturing equipment. The engineer will work cross-functionally with Quality, Commissioning, and Operations teams to ensure equipment meets regulatory and internal standards and is fully production-ready. This is a hands-on, high-impact role ideal for someone who thrives in fast-paced, highly regulated environments and enjoys bringing new manufacturing capabilities online.Compensation: $45/hr to $48/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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 Senior Equipment Process Engineer to support New Product Development (NPD) and manufacturing scale-up of medical devices in a regulated environment. This role will be long term... More and located in the Blue Ash, OH area. The equipment process engineer will be responsible for the development, qualification, and optimization of custom manufacturing equipment and processes that meet stringent quality, reliability, and regulatory requirements. The ideal candidate brings deep expertise in equipment-centric process development, supplier collaboration, and material-sensitive manufacturing processes, with a strong understanding of FDA and ISO expectations.The core responsibilities will include:-Develop and refine New Product Development (NPD) processes in compliance with FDA, ISO 13485, and internal quality system requirements.-Partner with equipment suppliers to design, build, and qualify new manufacturing equipment and process solutions.-Lead process characterization activities to identify and optimize Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).-Design and execute Design of Experiments (DOE); perform statistical analysis and establish process capability (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies to ensure sustained process performance.-Plan and execute Measurement System Analysis (MSA) and Gage R&R studies to validate measurement methods.-Provide hands-on technical support during equipment development, FAT/SAT, installation, qualification, validation, and production ramp-up.-Qualify and validate PLC-controlled software systems; troubleshoot issues, document changes, and support software fixes.-Collaborate cross-functionally with R&D, Manufacturing, Quality, and Supply Chain to drive compliant, scalable solutions to market.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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 seeking an experienced, highly skilled Sr Quality Engineer to support an established medical supply client out of Redmond, OR. Key Responsibilities:Develop and implement procedures... More for QMS, process control, validation, improvement, testing, and inspection.Partner with suppliers to resolve quality issues, ensuring corrective actions (CAPA, SCAR) are implemented.Provide Quality expertise in Product Development, Design Control, Risk Management, Validation, and QMS processes.Build and maintain Device Master Records (DMRs) in compliance with regulations.Collaborate with Regulatory Groups and internal departments to support 510K submissions and related documentation.Ensure compliance with domestic and international regulations.Perform quality reviews of design documentation, validation documentation, and company quality records.Lead investigations of product/process non-conformances and out-of-specification results.Develop and implement effective corrective and preventive actions.Train and mentor team members and employees on quality processes and best practices.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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 seeking an Operations Manager (1st Shift) to support a medical device manufacturing operation in Norwood, MA. This is a full-time, onsite leadership role responsible for overseeing... More first-shift operations across two manufacturing buildings and leading a high-performing operations team.Day-to-Day Responsibilities-Lead and motivate manufacturing teams across two facilities, fostering a culture of accountability, collaboration, and continuous improvement.-Manage daily production output, quality performance, shop floor controls, and task assignments.-Partner with planning, production supervisors, and engineering to manage day-to-day production activities.-Implement and maintain manufacturing process controls and quality standards to ensure compliance with customer, GMP, and ISO 13485 requirements.-Drive strategies to scale manufacturing operations in support of future growth.-Conduct resource planning and proactively identify staffing, equipment, and capability gaps.-Coach, mentor, and develop supervisors, leads, and production associates, including onboarding and performance development.-Establish and lead Lean manufacturing initiatives, including daily standups, Gemba walks, and continuous improvement projects.-Identify and implement process improvements to increase efficiency and reduce costs.-Collaborate with senior leadership and HR on hiring needs, training requirements, and workforce planning.-Ensure compliance with Quality, EHS, and OSHA requirements, policies, and procedures.-Establish departmental goals, track KPIs, manage budgets, and oversee departmental expenses.-Support performance management activities, including feedback, disciplinary actions, promotions, and performance reviews.-Perform other related duties as assigned.Compensation:$140,000 - $150,000 per year (annual salary)Exact compensation may vary based on skills, experience, and education.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 HR@insightglobal.com.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