31 Design Controls Jobs

Job Description Job Title: Regulatory Affairs No of Vacancy:1 Job Location: Andheri West Years of Experience: 1-4 years Working Days: Monday to Saturday Job Summary: We are seeking a motivated and detail-oriented Regulatory Affairs Executive to join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with domestic and international regulations across global markets including India, the US, and the EU. This role requires strong coordination skills and a proactive approach to support product registrations, audits, and technical submissions. Key Responsibilities: Conduct gap analysis of existing regulatory and technical d...

As a Human Factors Engineer 3 at Terumo Blood and Cell Technologies, you will be a key player in designing medical devices that support blood and cell therapies. Your role will involve leading human-centered design initiatives to ensure the safety, intuitiveness, and effectiveness of products for both clinicians and patients. Collaborating with various teams including R&D, Quality, Regulatory, and Clinical, you will conduct user research, usability testing, and risk assessments to optimize device interfaces and workflows. If you are passionate about innovation, improving patient outcomes, and thrive in a fast-paced, mission-driven environment, this is an opportunity for you to make a signifi...

Key Skills: Information Security, Cloud Security, Cyber Security, Informationcyber Security, Design controls, Certification Roles and Responsibilities: Monitor current and future security trends and incorporate them into security architecture guidance. Produce written technical documentation and reports; develop presentations on security approaches and solutions. Maintain a centralized Information Security Architecture data repository. Provide technical and security expertise to IT and business teams. Develop reference architectures, design patterns, and associated security standards. Understand security protocols, cryptography, authentication, and authorization best practices. Influence IT ...

As an Architectural & Interior Designer at our company, you will handle projects independently under the guidance of the Head Designs / Senior Architect. Your primary responsibilities will include project planning, coordination, material procurement, project site manpower management, and implementation of Architectural & Interior designing projects. You will be accountable for managing customer and contractor resources, ensuring quality and design checks, and maintaining control over the project outcomes. Additionally, you will collaborate with vendors for samples and meetings. Your key duties and responsibilities will include: - Handling projects independently while being guided by the Head...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Software Design Quality engineer to support CST ET products. Responsibilities may include the following and other duties may be assigned Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Hands on experience with tools package release process for both Software...

Role Overview: As a Project Architect / Interior Designer in the Architecture & Interior Designing department, you will handle projects independently under the guidance of the Head Designs or Senior Architect. Your main responsibilities will include project planning, coordination, material procurement, project site manpower management, and implementation of Architectural & Interior designing projects. You will be accountable for managing customer and contractor resources to ensure the successful completion of projects. Additionally, you will assist the Head Design / Senior Architect in all aspects of the site. Key Responsibilities: - Handle projects independently, under the guidance of Head ...

Job Title Senior Design Quality Engineer - Products & Systems Job Description Job Title: Design Quality Engineer Products & Systems Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical products so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. Closely work with the post market teams to bring back the learnings f...

Job Description Job Title: Software Design Quality Engineer Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. You are responsible for Ensure that appropriate project plan and quality plans are made that include all stages ...

Job Description Job Title: Design Quality Engineer u2013 Products & Systems Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical products so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. Closely work with the post market teams to bring back the learnings from the fielded products (Installed base) and work with ...

Job Title Software Design Quality Engineer Job Description Job Title: Software Design Quality Engineer Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. You are responsible for Ensure that appropriate project plan and qual...

Job Title Senior Design Quality Engineer - Products & Systems Job Description Job Title: Design Quality Engineer - Products & Systems Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical products so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. Closely work with the post market teams to bring back the learnings...

As the Lead of the Mechanical team at our company, you will be responsible for designing and developing advanced medical diagnostic devices. Your role will involve driving innovation in mechanical systems while ensuring reliability, manufacturability, and compliance with medical device standards. You will be expected to deliver robust solutions that seamlessly integrate with optical, microfluidic, electronic, and software subsystems. **Key Responsibilities:** - Lead product design and development from concept to validation and transfer to manufacturing, ensuring technical and process integrity. - Provide technical leadership in developing mechanical subsystems that integrate seamlessly with ...

Job Description Device Design & Engineering: Develop advanced wearable infusion pump based drug delivery systems. Sensor & Embedded Systems Integration: Implement microcontrollers, infusion mechanism (motor), biosensors, memory storage, real time clock, and real-time monitoring for drug delivery precision. Power Management & Miniaturization: Optimize battery life and ergonomic design for portable use. User interface (UI) Design: Ensure accessibility with clear visuals, alerts, and simple navigation and focus on Intuitive design, buttons, real-time display, customizable settings, alarms, emergency alerts Testing & Validation: Conduct bench, preclinical, and clinical device performance assessm...

Job Requirements Job Description: Sr. Technical Manager Job Summary We are seeking a Sr. Technical Manager with deep domain expertise in medtech products and devices. The selected candidate will lead technical engagements across the full product lifecycle, focusing on design, integration, compliance, and end-to-end lifecycle management of diagnostic imaging and critical care products/systems. This is a high-impact role requiring deep technical expertise and leadership, strong regulatory acumen, hands-on experience, and stakeholder management in complex medical hardware systems. Key Responsibilities Lead technical planning, development, and integration testing of imaging hardware systems. Ove...

Job Description Summary Assocaite Staff Engineer for Product Engineering . Med Tech Back Ground . Design Cntrols expertise . Mechnical Engineering Job Description Position Summary The Associate Staff Engineer is a technical leadership role within a sustaining engineering team who will own, lead and support the end-to-end Design and engineering deliverables and solutions for high-volume medical device products right from Design and Development to Verification and Validation activities. (S)he, working with the local and global stakeholders, will deliver relevant solutions to new and existing products through design calculations, risk-retirement using first principles engineering, technical ana...

The Systems Engineer V&V (Medical Device) will collaborate closely with cross-functional engineering teams and focuses on supporting the execution of test cases and test strategies, ensuring the high performance and reliability of products in Surgical Robotics. Experience: 4-12 Years Location: Hyderabad (Work From Office) - Hybrid Responsibilities may include the following and other duties may be assigned Work in a multi-disciplinary team developing test methods for a complex, electro-mechanical system Test Method Development, Root Cause Analysis, Capability studies, Fixture Qualification, Risk Management & Non-Product software validation Validate HW/SW Fixtures and Test Methods Write valida...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic is seeking a dynamic Associate Engineering Director to lead embedded and platform software development and sustaining engineering programs for its Surgical Robotics platform. This role requires building and managing a high-performing team of engineers, driving both new product development and existing system enhancements. You will oversee cross-functional engineering effortsespecially in software development, verification, an...

As a Design Engineer at our company, you will have the following responsibilities: - Conducting process design of agitator systems based on provided data - Performing mechanical design of agitator systems, including shaft design for various mounting options and impeller blade thickness - Optimizing agitator designs based on process parameters and mechanical considerations to reduce overall costs - Leading communication with suppliers and subcontractors regarding design specifications - Designing and estimating chemical reactors and mixer vessels - Utilizing technical skills for process and mechanical design of agitators - Conducting accurate estimations for agitator designs - Applying critic...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Reporting to a Systems Engineering Manager in the Surgical OU, the Senior Systems Engineer is responsible for both leading and contributing to investigations and root causing of issues associated with the Hugo Robotically Assisted Surgical System. The successful candidate will work with a cross functional team to support sustaining activities, perform impact assessments, evaluate requirements, and document system and subsystem architec...

Job Description Summary Assocaite Staff Engineer for Product Engineering . Med Tech Back Ground . Design Cntrols expertise . Mechnical Engineering Job Description Position Summary The Associate Staff Engineer is a technical leadership role within a sustaining engineering team who will own, lead and support the end-to-end Design and engineering deliverables and solutions for high-volume medical device products right from Design and Development to Verification and Validation activities. (S)he, working with the local and global stakeholders, will deliver relevant solutions to new and existing products through design calculations, risk-retirement using first principles engineering, technical ana...

Job Title Design Quality Engineer - Medical Devices Job Description The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your Role Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability...

Key Skills: Design controls, PLM Roles and Responsibilities: Plan and execute the migration of Design History Files from the current systems to Teamcenter PLM. Develop and maintain Design Control and Risk Management documentation in the PLM system. Collaborate with cross-functional teams to ensure seamless implementation of Teamcenter PLM into the organization. Provide support and/or training to team members on the use of digitized tools and processes. Utilize Polarion requirements management tools to manage and track requirements. Ensure compliance with Design Control regulations and standards for medical devices. Identify and implement process improvements to enhance efficiency and complia...

Job Description Summary Assocaite Staff Engineer for Product Engineering . Med Tech Back Ground . Design Cntrols expertise . Mechnical Engineering Job Description Position Summary The Associate Staff Engineer is a technical leadership role within a sustaining engineering team who will own, lead and support the end-to-end Design and engineering deliverables and solutions for high-volume medical device products right from Design and Development to Verification and Validation activities. (S)he, working with the local and global stakeholders, will deliver relevant solutions to new and existing products through design calculations, risk-retirement using first principles engineering, technical ana...

As a Human Factors Engineer 3 at Terumo Blood and Cell Technologies, you will be involved in designing life-changing medical devices that support blood and cell therapies. Your role will include leading human-centered design initiatives to ensure that the products are safe, intuitive, and effective for both clinicians and patients. By collaborating closely with cross-functional teams such as R&D, Quality, Regulatory, and Clinical, you will conduct user research, usability testing, and risk assessments to optimize device interfaces and workflows. This is a great opportunity for you to contribute to the future of healthcare by driving innovation and improving patient outcomes in a fast-paced, ...

Job Description Every career journey is personal. That's why we empower you with the tools and support to create your own success story. Be challenged. Be heard. Be valued. Be you ... be here. Job Summary The Sr Analyst, Validation Center of Excellence is accountable for performing execution of critical credible challenge activities for the Bread Financial (BFH) Enterprise Risk Organization (ERO). This includes validation of activities performed by the first lines of defense to guard against financial loss and other business risks. As the Sr Analyst, you will support and enable senior leaders and functional experts across BFH to integrate risk management practices into their strategic busine...