Job Search Results for medical device regulations

We are seeking a Senior iOS Developer to join a globally distributed mobile engineering team supporting a medical device mobile application. This role is heavily hands-on while also providing... More technical leadership and mentorship to junior engineers across multiple locations.You?ll work on a native iOS application used to control Bluetooth-enabled hearing aids and provide health-related features such as fall detection, activity tracking, and device configuration.Key ResponsibilitiesDesign and develop native iOS applications using SwiftBreak down complex product requirements into clear, executable technical solutionsGuide and mentor junior and mid-level engineers (approximately 30?40% of the role)Collaborate daily with offshore development teams (India, China, Israel)Participate in design discussions, code reviews, and architectural decisionsWork closely with product, verification, and hardware teamsBuild stable, regulated software within a medical device environment (quality, documentation, review-heavy process)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.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

R&D Manager ? Product Engineering (Capital Sustaining)Location: Marlborough / Greater Boston AreaWork Model: Onsite ? 5 days per week (flexibility expected over time, but the role should be... More positioned as onsite)Division: Research & DevelopmentTeam Size: 3 engineers currently (including 2 Lead Engineers, with planned growth)About the RoleA leading medical device organization is seeking an R&D Manager ? Product Engineering to support the sustaining and evolution of a complex capital equipment portfolio. This role is accountable for ensuring product reliability, regulatory compliance, and long-term lifecycle viability across Class II medical devices.This is a highly hands-on, onsite leadership position that requires close, day-to-day collaboration with Manufacturing, Design Assurance, Quality, Lifecycle Management, and Post-Market teams. The ideal candidate is comfortable operating in ambiguity, can effectively triage competing priorities, and is willing to step in where needed to keep critical workstreams moving forward.A significant focus of this role will be on legacy portfolio visibility, remediation efforts, and lifecycle decision-making. The manager will play a key role in strengthening overall quality, compliance, and sustaining engineering practices across the broader organization.Key ResponsibilitiesProduct Sustaining & Lifecycle Management? Lead sustaining engineering activities for a portfolio of capital medical devices, balancing technical, regulatory, and business priorities.? Own and guide end-of-life (EOL) strategies, including component obsolescence, product replacement planning, re-testing, rationalization, and next-generation replacement efforts.? Drive decision-making around when to remediate, redesign, replace, or retire products, ensuring patient safety, compliance, and continuity.? Act as a ?player-coach?, stepping in as needed to fill technical or execution gaps and keep initiatives moving forward.Remediation, Quality & Compliance? Partner closely with Quality and Design Assurance to lead and execute remediation programs across legacy products and multiple business units.? Improve the overall approach to quality and compliance, driving visibility, structure, and accountability across the legacy portfolio.? Ensure products and engineering activities remain aligned with internal QMS, FDA Design Controls, Risk Management requirements, and ISO 13485 standards.? Support and lead CAPA-driven remediation efforts, working hands-on with quality partners to define and execute corrective actions.? Provide a strong engineering perspective when working with quality teams?constructively pushing back where needed to ensure remediation plans are technically sound, risk-based, and pragmatic.? Maintain awareness of compliance considerations such as EMI/EMC and applicable regulatory testing requirements.Cross-Functional & Manufacturing Collaboration? Work closely and daily with Manufacturing teams, lifecycle management partners, and post-market colleagues to resolve field issues, manufacturing challenges, and customer-reported defects.? Triage incoming demands from multiple stakeholders, helping prioritize work that delivers the greatest impact and makes the most technical and business sense.? Serve as a primary interface between Engineering, Manufacturing, Quality, Design Assurance, and Post-Market teams, clearly communicating tradeoffs and priorities.Team Leadership & Vision? Lead and develop a small but critical team of engineers, currently consisting of 2 Lead Engineers, with plans to grow.? Establish a clear vision for a new and evolving team, including how the group should scale, where capabilities need to expand, and what success looks like.? Balance people development and technical credibility?this role values both strong leadership acumen and deep engineering experience.? Manage performance, provide coaching and feedback, and support professional growth.? Bring prior people management experience, while remaining comfortable working within a lean team environment.Program & Execution Management? Apply strong program management discipline to manage multiple parallel initiatives across remediation, sustaining engineering, and lifecycle updates.? Allocate resources effectively across Lifecycle Management, Quality, and Compliance initiatives.? Communicate clearly and effectively with both technical and non-technical stakeholders through documentation, presentations, and regular updates.? Advocate for and manage the team?s budget and resourcing needs.Compensation: $122,000 to $190,000. 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

An employer is seeking NPD Equipment Engineer with a strong focus on manufacturing data collection, pilot execution, and process control to support medical device production in the Blue Ash, OH area.... More This role bridges manufacturing execution with data systems to enable robust process monitoring, capability analysis, and continuous improvement. The ideal candidate excels in pilot build coordination, manufacturing data systems, and translating production data into actionable insights that support compliance, efficiency, and scalability. Core responsibilities will include:-Support New Product Development (NPD) and manufacturing scale-up in compliance with FDA, ISO 13485, and internal quality systems.-Plan and execute engineering and pilot builds, coordinating cross-functionally to transition processes into full production.-Develop and execute process characterization plans to identify and optimize CPPs and CQAs.-Design and execute DOE and statistical analyses; establish process capability metrics (Cp/Cpk, Pp/Ppk).-Define and implement process control limits, control plans, and monitoring strategies using manufacturing data systems.-Lead Measurement System Analysis (MSA) and Gage R&R activities to ensure data integrity and measurement reliability.-Provide hands-on manufacturing support during development, qualification, validation, and production stabilization.-Author and execute protocols and audit-ready completion reports in support of process validation and regulatory inspections.-Support validation and troubleshooting of PLC-controlled manufacturing systems in collaboration with automation and controls teams.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

The Urology R&D organization is seeking a highly skilled and motivated Electrical Engineer, with a focus in Test Method Validation to support an acquisition and integration project for a duration of... More 9 months, with the option to extend.In this role, you will be responsible for creating, validating, and documenting test methods for electrical and medical electrical equipment, ensuring compliance with work instructions, SOPs, and applicable standards. A major focus of this position is test method development and validation, including the creation of approximately 60 test method protocols, execution or oversight of validation activities, and preparation of final technical reports. This role will assess acquired company test methods to determine validation needs, perform or coordinate validation testing (e.g., Gauge R&R), and update documentation to justify when validation testing is not required. You will also support technician scheduling and training, perform statistical data analysis using Minitab, and generate final validation and engineering reports.As a key team member, you will provide technical testing solutions and engineering support under guidance from subject matter experts, applying your background in electrical/systems engineering, test method design, test method validation, verification testing, and statistical analysis.Test Method Development & Validation-Develop, write, and maintain test method protocols, with an expected workload of approximately 60 test method protocols during the project.-Create new test methods and improve existing methods for electrical and medical electrical equipment.-Perform and/or oversee test method validation activities, including Gauge R&R and other statistical validation techniques, to ensure compliance with Boston Scientific standards.-Assess acquired company test methods to determine whether validation is required and either execute appropriate validation testing, or update technical documentation with a sound engineering rationale when validation is not required.-Identify gaps in test method validation compliance and define strategies to close those gaps.Testing Execution & Technical Support-Provide hands-on technical support for verification and validation testing activities.-Assess feasibility and soundness of alternative test methods, engineering processes, products, or equipment.-Complete complex or novel assignments requiring the development of new or improved testing techniques and procedures.-Support efficient and effective integration of acquired medical device technologies into the Boston Scientific portfolio.Technician Coordination & Training-Assist with scheduling test technicians to support validation and verification activities.Ensure technicians are properly trained on test methods, protocols, and procedures.Provide technical guidance to technicians during test execution.Data Analysis & Reporting-Perform statistical data analysis using Minitab, including Gauge R&R and process capability studies.-Analyze test results, draw conclusions, and make engineering recommendations based on data from multiple sources.-Write clear, concise final reports, including test method validation reports and technical summaries.Complete high-quality engineering documentation in accordance with Boston Scientific quality systems.Communication & Project Support-Provide input to project goals, timelines, and progress.-Communicate technical progress, risks, and trade-offs to project leadership.-Recommend revisions to testing strategies, documentation, or plans as needed.-Demonstrate strong knowledge of Technology Development and Product Development systems through delivery of high-impact deliverables.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 Med Tech Client is looking for a Software Quality Engineer to lead quality activities throughout the SDLC for Software as a Medical Device. This person would be responsible for... More formalizing a validation plan, testing and executing validation strategy, and providing documentation that shows the impact to the product. The Software Engineer will be working across several tools, applications and software to understand what is tied to the product to understand the impact as the company is going through a divestiture. This person should understand the appropriate level of validation needed, understand pass/fail requirements, risk management and have strong problem solving skills. Experience in Cybersecurity would be a plus. The Software Quality Engineer should also be familiar with IEC 62304.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 in the Cincinnati, OH area is seeking a Equipment Development Engineer for a long-term opportunity. This Equipment Development engineer will support a project focused on a handheld... More commercial product launch. This Engineer will need to have experience overseeing a manufacturing cell and will be required to validate all phases of the manufacturing process (vision systems, component qualification, cell automation and documentation). This will be a mostly high-volume manual production assembly process with 500k units produced per year. The engineer will support validation of suppliers, working cross functionally with the lifecycle team to drive line movement and oversee the ongoing project schedule. Prior experience within the medical device industry will be a plus to help adhere to GMP standards. Minimal local travel will be required and the on-site responsibilities will be 3 days a week in Blue Ash. Comfortable with some international travel, paced to increase in 2027. Both front end development and then back-end process after validation experience, so full Lifecyle.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 Fortune 500 company is seeking a candidate to join a growing quality engineering team supporting the development of a cutting-edge medical device. This individual will work closely within agile... More scrum teams to plan and execute both manual and automated testing across new and existing software features. They will review product requirements to ensure testability, build and maintain automated test scripts, and perform functional, performance, load, and reliability testing to ensure product quality. The role also involves validating design changes, maintaining detailed test documentation, and ensuring compliance with regulated medical device standards. In addition, this individual will support AI-enabled functionality by preparing validation datasets, analyzing model metrics, and identifying test scenarios that have the greatest impact on end users and customers. This role is hybrid, 3 days onsite, Wednesday required.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 in the Cincinnati, OH area is seeking a Equipment Validation Engineer for a long-term opportunity. This Validation Development engineer will support a project focused on a handheld... More commercial product launch. This Engineer will need to have experience overseeing a manufacturing cell and will be required to validate all phases of the manufacturing process (vision systems, component qualification, cell automation and documentation). This will be a mostly high-volume manual production assembly process with 500k units produced per year. The equipment development engineer will be validating equipment while working cross functionally with the lifecycle team to drive line movement and oversee the ongoing project schedule. Prior experience within the medical device industry will be a plus to help adhere to GMP standards. Minimal local travel will be required and the on-site responsibilities will be 3 days a week in Blue Ash. Comfortable with some international travel, paced to increase in 2027. Both front end development and then back-end process after validation experience, so full Lifecyle.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

Our client is seeking a reliable and hardworking Warehouse Associate to join their growing team at their Milwaukee facility. This role is primarily focused on device receiving and inventory... More management during the first 2?3 hours of each shift, after which the associate will transition to support the White Glove onboarding team for the remainder of the day. The ideal candidate is an early riser who is comfortable with physical labor, works well in a team environment, and is eager to learn new systems and processes.Responsibilities?Receive and process incoming device shipments as they arrive at the Milwaukee office?Track and manage device inventory accurately?Lift, move, and organize heavy boxes and equipment throughout the warehouse?Wrap pallets and maintain an organized warehouse environment to support the White Glove onboarding team?Transition to support the White Glove team after completing morning receiving duties to assist with device onboarding?Log and document device activity using ticketing systems (Autotask)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

This role will support a global, mission-driven medical technology company developing cloud-connected, software-driven products that integrate with mobile applications and data platforms in a highly... More regulated environment. The Senior Systems Test Engineer will lead the definition, analysis, and management of software and system requirements for cloud-integrated solutions, partnering closely with product, software engineering, quality, and regulatory teams. This individual will translate user needs and product requirements into clear, testable software and system requirements, maintain end-to-end traceability, and ensure design outputs meet regulatory and quality standards. The role is hands-off from a coding perspective and instead focuses on requirements development, technical reviews, risk management, and alignment across cross-functional stakeholders to support compliant, scalable cloud-enabled products.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