116 Design Control Jobs - Page 2

Job Description Summary The right candidate will be placed in the Product engineering or product development team. The Senior Engineer will be involved with all aspects of design engineering including new product design and optimizing existing products. In doing so the Senior Engineer will follow BDs Global Product Development System and relevant engineering tools to deliver a high quality, cost-effective design using BD's Stage Gate framework, DFM/DFSS to deliver cost-effective design-transfer and see it through into manufacturing. The associate will also be responsible for supporting the verification strategy creation and execution to deliver high-volume medical products. The successful ca...

Role & responsibilities Lead implementation and continuous improvement of ISO 13485-compliant QMS. Ensure compliance with FDA QSR (21 CFR 820), EU MDR, and other applicable regulatory requirements. Manage internal and external audits (FDA, notified bodies, ISO, etc.). Oversee document control, change control, and quality records management. Approve quality documentation, SOPs, DMRs, DHFs, and technical files. Lead root cause investigations and implement effective corrective and preventive actions. Manage nonconformances and track resolution effectiveness. Approve and audit suppliers and subcontractors. Ensure incoming materials and components meet specifications. Collaborate with production ...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Radiometer, one of 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. At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We're a team that celebrates diverse ideas and continuous improvement. Here...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Radiometer, one of 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. At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We're a team that celebrates diverse ideas and continuous improvement. Here...

Educational Requirements Bachelor of Engineering,Bachelor Of Technology Service Line Engineering Services Responsibilities " Bachelor's or Master's degree in Mechanical Engineering Hands-on experience with medical device design control Experience in mechanical product design and development Proficiency in design change management, design documentation, risk management, and DFMEA Familiarity with Windchill or equivalent PLM tool. Experience in DHF/DMR remediation. Proficiency in both written and verbal communication Preferably, experience in the medical device industry" Technical and Professional Requirements: CAD - Solidworks & GDnT knowledge Preferred Skills: Technology->CAD->Solid Works

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...

**Job Description:** As the Quality Assurance Principal at DeepHealth, you will play a crucial role in supporting the company's products and product development processes. You will collaborate cross-functionally to guide product development, ensure quality processes are in place, and maintain compliance with relevant standards and regulations. **Key Responsibilities:** - Actively engage with Engineering, Clinical, and Marketing teams to develop new products within the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes. - Lead quality initiatives for design changes to existing DeepHealth products, ensuring compliance with applicable standards. - Mentor junior Qual...

As an R&D Executive at PTC - MORAIYA, your role involves characterizing materials and developing/qualifying packaging systems, including primary, secondary, and tertiary packaging. You will be responsible for completing design control deliverables, supporting relevant regulatory requirements for submission, and providing post-launch troubleshooting support for complex products. Your tasks also include developing drug delivery devices like Pen Devices, Auto Injectors, DPI, and pMDI while ensuring a comprehensive understanding of regulatory expectations. Key Responsibilities: - Compile documents such as URS and design control/history file for combination products - Perform functional performan...

Job Title: Mechanical Engineer R&D (Medical Devices) Location: Bangalore Experience: 2 to 4 years Salary: 5 to 10 LPA Industry: Medical Technology / Healthcare Devices Functional Area: Research & Development / Product Design & Engineering About the Role: We are seeking a highly motivated Mechanical Engineer to join the R&D team of a global medical technology solutions provider . The role involves contributing to the end-to-end product design and development lifecycle , from concept to production, for electro-mechanical medical devices and related products. Key Responsibilities: Participate in concept design, planning, development, and execution stages of new products. Analyze design requirem...

Who we want: The Tools Administrator will assist in the ongoing adaptation and deployment of new tools such as JAMA Windchill/ DOORS. The administrator will work closely with functional leaders, organizational units, and subject matter experts to identify develop and deploy new business processes. This role is part administrator, part quality analyst and part trainer. The Administrator will be responsible for executing on the day-to-day configuration, support, maintenance and improvement of the tools, qualification of the tools and associated processes. The Administrator will manage the relationship with the software vendors and be responsible for documenting and updating internal processes ...

Knowledge of JAMA workflows or similar tools like JIRA. DOORS, IBM SYNERGY, PTC INTEGRITY. Understanding of engineering lifecycle phases and design control processes is preferred. Proven ability to design and implement new process Required Candidate profile Function:QA Role:Software engineer Desired Skills:Quality assurance, JIRA. DOORS, IBM SYNERGY, PTC INTEGRITY Experience validating third party tools to comply with Quality Management system

Role Overview: As a Lead Quality Engineer, you will be accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. You will handle projects and tasks from product inception through product launch and maintenance, playing an active role in ensuring products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. You will work under general direction, independently determining and developing approaches to solutions, with frequent inter-organizational contacts to achieve stated objectives. Key Responsibilities: - Support d...

As a Quality Engineering Specialist within the Medline UNITE Foot and Ankle Orthopaedics Division in Pune, India, you will play a crucial role in maintaining quality standards aligned with strategic engineering objectives. Your responsibilities include providing quality support for complaint investigations, routine product evaluations, product testing, documentation, and vendor qualification processes. Additionally, you will contribute to new product development and legacy engineering projects related to implantable foot and ankle products and accessories. Your ability to thrive in a team environment, demonstrate a strong sense of urgency, and build effective working relationships with peers...

Role Overview: You will be responsible for mechanical design in the industrial, construction, and Hydraulic Machinery sectors. Your key responsibilities will include: - Designing mechanical structures for machinery - Creating Bill of materials for mechanical components - Preparing manufacturing drawings & 3D modelling - Designing fixturing and packing fixtures - Coordinating with stakeholders for manufacturing - Demonstrating proficiency in CAD tools, especially AutoCAD and CREO - Conducting benchmarking, competitor analysis, cost analysis, and value engineering Qualification Required: - Bachelor of Engineering (BE) degree Please note that this job posting is for a position in the MIPD-Indus...

Job Description Summary The right candidate will be placed in the Product engineering or product development team. The Senior Engineer will be involved with all aspects of design engineering including new product design and optimizing existing products. In doing so the Senior Engineer will follow BDs Global Product Development System and relevant engineering tools to deliver a high quality, cost-effective design using BD's Stage Gate framework, DFM/DFSS to deliver cost-effective design-transfer and see it through into manufacturing. The associate will also be responsible for supporting the verification strategy creation and execution to deliver high-volume medical products. The successful ca...

Job Description Summary The Design Engineer will assist the design and engineering solutions for high-volume medical device products. (S)he, under the mentorship of a lead or senior engineer, will deliver relevant solutions to new and existing products through design iterations, risk-retirement using first principles engineering, technical analyses/FMEA and verification of the design. The Design Engineer will learn and utilize BD's stage gate Global Product Development System and use DFM/DFSS and relevant engineering tools to deliver a high quality, robust and cost-effective design and will partner cross-functionally to execute all aspects of product development. They will also ensure succes...

Job Description Summary The Design Engineer will assist the design and engineering solutions for high-volume medical device products. (S)he, under the mentorship of a lead or senior engineer, will deliver relevant solutions to new and existing products through design iterations, risk-retirement using first principles engineering, technical analyses/FMEA and verification of the design. The Design Engineer will learn and utilize BD's stage gate Global Product Development System and use DFM/DFSS and relevant engineering tools to deliver a high quality, robust and cost-effective design and will partner cross-functionally to execute all aspects of product development. They will also ensure succes...

Job Description Summary The Design Engineer will assist the design and engineering solutions for high-volume medical device products. (S)he, under the mentorship of a lead or senior engineer, will deliver relevant solutions to existing products through Project scoping, Project planning, design iterations, risk-retirement using first principles engineering, technical analyses/FMEA and verification of the design. The Design Engineer will learn and utilize BD's stage gate Global Product Development System and use DFM/DFSS and relevant engineering tools to deliver a high quality, robust and cost-effective design and will partner cross-functionally to execute all aspects of product engineering pr...

Educational Requirements Bachelor of Engineering,Bachelor Of Technology Service Line Engineering Services Responsibilities " Bachelor's or Master's degree in Mechanical Engineering Hands-on experience with medical device design control Experience in mechanical product design and development Proficiency in design change management, design documentation, risk management, and DFMEA Familiarity with Windchill or equivalent PLM tool. Experience in DHF/DMR remediation. Proficiency in both written and verbal communication Preferably, experience in the medical device industry" Technical and Professional Requirements: CAD - Solidworks & GDnT knowledge Preferred Skills: Technology->CAD->Solid Works

Job Title: New Product Development Trainer Location: Remote Job type: Part -time Job Summary: We are seeking an experienced NPD Trainer with over a decade of hands-on expertise in medical device design, product development, validation, and regulatory compliance . The Trainer will be responsible for designing and delivering structured training programs to upskill engineers, technicians, and project managers in end-to-end new product development processes from concept to commercialization. The ideal candidate should possess strong technical depth, familiarity with ISO 13485, FDA 21 CFR Part 820, and Design Control requirements, and the ability to translate complex product development concepts ...

Job Description Summary Performs a variety of quality assurance activities to ensure successful completion of projects or aspects of large programs. Applies technical expertise and knowledge of advanced statistical techniques to support engineering work in the design, development, and evaluation of medical devices. Supports development and successful implementation of quality systems and procedures. Supports maintenance and expansion of QMS as required. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stated objectives. Job Description Educational Background Bachelor's degree in mechanical en...

Hello Visionary! We empower our people to stay resilient and relevant in a constantly changing world. Were looking for people who are always searching for creative ways to grow and learn. People who want to make a real impact, now and in the future. Does that sound like you? Then it seems like youd make an outstanding addition to our vibrant team. Siemens Mobility is an independent run company of Siemens AG. Its core business includes rail vehicles, rail automation and electrification solutions, turnkey systems, intelligent road traffic technology and related services. In Mobility, we help our customers meet the need for hard-working mobility solutions. Were making the lives of people who tr...

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 livesand 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 workflows. ...

Role & responsibilities Design of control & automation of Power Transformer, Auto Transformer & Switch Gear including RTCC panels and OLTC controls. Develop Power Transformer control design including the cooling fan control, Onload Tap changer, current Transformer, SCADA, PLC etc. Perform Load calculation for wire size and circuit protection. Review Technical specifications and prepare design note to proceed with Electrical, Control Design & cooling with respect to customer requirement. Prepare wiring diagram and bill of materials of the control panels. Key Expertise: IT Skills: Conversant with working in an ERP System. Proficient in using MS Word and Excel. Additional Skills: - Having 3 to ...

Job Description Summary As directed by the Quality Manager, the Lead Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while Meeting All Design Control And Other Regulatory Requirements. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization contacts to achieve stat...