117 Design Control Jobs - Page 4

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufa...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At HemoCue, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflow...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Youll make a difference by Develop hardware controls for innovative rail vehicles as part of a collaborative team. Responsible for the electrical integration of subsystems. Design control and power circuits. Develop cost-optimized hardware solutions during the concept phase in close cooperation with software developers. Define relevant system interfaces in collaboration with internal and external stakeholders. Create circuit diagrams and documentation for electrical assembly using advanced CAD software. Generate electrical wire lists, BOMs, and component specifications. Continuously expand your knowledge to take on increasingly complex hardware development tasks. Manage subcontracting mandat...

Job Description: To apply to a Varex Imaging position, please create an account and sign-in. CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account. Varex Imaging is hiring a System Software Engineer in Test in the fast-growing X-Ray Imaging Components division. The Software Engineer in Test will bring real-world experience to our team by helping to develop automated integration and robustness testing to ensure system software performs as designed. We are looking for candidates that will thrive in a fast-paced, self-directed environment and can hit the ground running in a critical division of our company. There will be opportunities to work both individua...

Role & responsibilities: Responsible for monitoring and management of projects in assigned division / sub-division / ULBs. Day-to-day supervision of construction works including design control, quality assurance and quality control, schedule, and budget control. Assessing adequacy of contractors plant, equipment, materials, labour to carry out works as the per approved work program. Performance monitoring of works contractors. Report on tests. Review of contractors submittals such as work plans, work schedules, method statements, progress reports, designs, and drawings, etc. Preparation of daily, weekly, monthly progress reports. Maintaining photographic records of each assigned project. Res...

Role & responsibilities 1. Hands on experience in design controls requirements in medical device industry 2. Design verification, Design Outputs etc. 3. Experience developing test protocols and test plans 4. Strong Communication (written & verbal). 5. Ability to collaborate effectively with cross-functional teams 6. Knowledge in PLM/ALM tools (SAP, Team Centre, Windchill, etc.) 7. Technical knowledge of engineering statistics (Minitab Preferred)

Join a team that values innovation, growth, and impactful work. Don't miss the chance to work with cutting-edge projects in SME and be a part of something transformative! Drive Date: 26th July Saturday (9AM-2PM) Skills Required: - Experience in DHF remediation - Proficiency in Design Control, Design Verification, and Design Validation - Expertise in WindchillPLM in the medical domain Venue Location: HCLTech Elcot Sez, New Cafeteria 2nd Floor, 602/3, 138, Medavakkam High Road, Sholinganallur, Chennai-600119 Position: Mechanical Design (Lead, Technical Lead) Experience: 2.5-10 years Job Location: Chennai Job Description: - B.E / B.Tech or higher education in Mechanical Engineering - Sustaining...

As a Senior Analyst in R&D Compliance Specification at Kimberly-Clark, you are a dedicated learner and a natural leader who takes initiative to improve processes and engage others in the journey. Your commitment to integrity and quality is unwavering, ensuring that your responsibilities contribute to long-term success. By joining our team, you will play a crucial role in enhancing healthcare for billions of individuals worldwide, starting with your efforts. Reporting to the R&D Center of Excellence Leader, you will be an integral part of the EM R&D Team. Your main responsibility will be to ensure that all products and processes adhere to regulatory standards and internal specifications. This...

Job Summary: We are seeking for a highly motivated Associate to join the Design Control team. The ideal candidate will have experience in Design Control and Risk Management of Medical Devices, proficiency with Teamcenter PLM or similar product lifecycle management tools and with Polarion or similar requirements management tools. This role will play an important role in transforming and uplifting Design History Files to Teamcenter PLM and maintaining DHF documentation in the PLM system. Key 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....

You will be responsible for Mechanical design in the field of Medical Devices, with a focus on Medical Device Design Controls, Design Verification, and Validation processes. A minimum of 3 to 5 years of relevant experience is required for this role. As a Sustaining Engineer, you will lead Change Qualification projects for medical devices, collaborating with a diverse Cross-Functional Team. Your tasks will include developing test protocols, ensuring the quality of deliverables, and managing risk through proactive identification and mitigation planning. Proficiency in DesignControl process for Medical Devices is essential, along with expertise in Mechanical Engineering basics. You should posse...

As a member of the Biocon Biologics team, you will be part of a company that is shaping the future of healthcare by prioritizing patients and aiming to impact a billion lives. Our focus on affordable innovation, patient centricity, and disruptive thinking drives us to deliver high quality biosimilars globally. We are a diverse, global company that values purpose and passion in our employees, who work together closely with partners and patients to bring innovative healthcare solutions to the market. Your role will involve leading the full lifecycle execution of medical device development programs, ensuring alignment with design control and regulatory standards. You will be responsible for man...

You will be responsible for mechanical design tasks related to industrial, construction, and Hydraulic Machinery. Your key duties will include designing mechanical structures for machinery, creating Bill of Materials for mechanical components, preparing manufacturing drawings & 3D modeling, designing fixturing and packing fixtures, coordinating with stakeholders for manufacturing, and demonstrating expertise in CAD tools. Proficiency in AutoCAD and CREO is mandatory. Additionally, you will be involved in benchmarking, competitor analysis, cost analysis, and value engineering to ensure high-quality design solutions. This role requires a Bachelor of Engineering (BE) degree and 3-8 years of rel...

As a Medical Mechanical Design Verification/Control Engineer at HCLTech in Chennai Shollinganallur, you will be joining a team that values innovation, growth, and impactful work. This is an opportunity to work on cutting-edge projects in SME and be a part of something transformative! The walk-in drive is scheduled for 21st July Saturday from 9AM to 2PM at HCLTech Elcot Sez, 602/3, 138, Medavakkam High Road, Sholinganallur, Chennai-600119. The position available is for Mechanical Design (Lead, Technical Lead /Sr Lead) with an experience requirement of 3-7 years. To be eligible for this role, you should have a B.E/B.Tech or higher education in Mechanical Engineering. Sustaining Engineers are e...

HCLTech WalkInDrive In Chennai for Mechanical Engineers on 26th July Saturday. CONSIDER THIS AS CALLLETTER Medical Mechanical DHF/ windchillPLM/Design Verification/Control Engineer- WalkIN on 26th July in Chennai Shollinganallur Join a team that values innovation, growth, and impactful work. Dont miss the chance to work with cutting-edge Project in SME and be a part of something transformative! Drive Date:26th July Saturday (9AM-2PM) Skill1: #DHF #remediation #DHFremediation Skill2: #Designcontrol #designverfication #designvalidation Skill3: #WindchillPLM in medical domain Contact Person: Katherine Sylvia Venue Location: #HCLTech Elcot Sez, 602/3, 138, Medavakkam High Road, Sholinganallur, #...

HCLTech WalkInDrive In Chennai for Mechanical Medical Design Verification Engineer on 26th July Saturday. ( Medical Devices experience - Preferable or equalent Experience) Job Location : Chennai DriveDate :26th July Saturday (9AM-2PM) Venue Location : Chennai HCLTech Elcot Sez, New Cafeteria 2nd Floor 602/3, 138, Medavakkam High Road, Sholinganallur,hashtag Chennai -600119 Position : Mechanicaldesign (Engineer, Lead) APPLY - https://lnkd.in/gHQ5PFt6 Experience : 2.5-9 years Skill : M edical device, Design control, Design Verification, DHF, MD, Design validation ISO 13485 DHF remediation D esign history files JD : B.E / B.Tech or higher education in Mechanical Engineering EXPERIENCE : • Susta...

Join our Sustaining Engineering Team and contribute to: New Product Development (NPD) Design History File (DHF) updates Risk Management & DFMEA Verification & Validation (V&V) Design Controls Required Candidate profile Experince range 4 to 15 years only. Medical experince is must. Only immediate and serving notice period required.

Desired Skills:Quality assurance, JIRA. DOORS, IBM SYNERGY, PTC INTEGRITYKnowledge of JAMA workflows or similar tools like JIRA. DOORS, IBM SYNERGY, PTC INTEGRITYUnderstanding of engineering lifecycle phases and design control processes is preferred. Required Candidate profile Proven ability to design and implement new processes and facilitate user adoption. Knowledge of Requirement Management and Test Management, Traceability. Experience validating third party tools

As a candidate for the position at Bengaluru Luxor North Tower, you will be expected to possess the following qualifications and skills: Agile and distributed decision-making using evidence and applying judgment to balance pace, rigor, and risk. You should be able to manage individual and team performance effectively, committed to delivering high-quality results, overcoming challenges, and focusing on execution. Implementing change initiatives, leading change, and sustaining energy and well-being in teams are essential aspects of the role. You should continuously seek opportunities to learn, build skills, and share learning both internally and externally. Developing people, building a talent...

Career Area: Engineering : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you'rejoining a global team who cares not just about the work we do but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don'tjust talk about progress and innovation here we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Job Summary Caterpillar is seeking a highly motivated and experienced Senior Design Engineer to join our team focused on genset applications. This role is critical in delivering high-performanc...

Responsibilities: * Collaborate with design team on project requirements and specifications. * Maintain cleanliness and organization of workspace. * Load, operate, and unload 3D printers safely.

Role & responsibilities Leads the evaluation and development of Disposables on assigned projects with focus on risk management. Owns and maintains the risk management files for the assigned product families. Manages all technical complexities of the work, and effectively communicates with all project team members and stakeholders. This includes reporting pertinent information at key milestones. Collaborates with cross functional team (e.g., Quality, regulatory, clinical) to ensure the proper deployment of risk management activities. Manages and prioritizes multiple projects and tasks. Develops solutions and approaches to complex problems through application and adaptation of state-of-the-art...

Join our Sustaining Project Team as a Design Quality Engineer. Handle DHF, risk management, V&V, doc control, and ensure compliance with quality systems & regulatory standards. Experience with PLCP, FMEA, and CAPA is preferred. Required Candidate profile This role is strictly focused on Design Quality Engineering. It does not include Regulatory Affairs or Post-Market Surveillance (PMS) responsibilities.