35 Dhf Jobs

Key Responsibilities Provide quality support to design and development teams. Review and approve design control documents (DHF, DMR, Risk Management File). Ensure compliance with ISO 13485, ISO 14971, and applicable regulatory standards. Participate in design reviews and risk assessments. Support verification, validation, and design transfer activities. Drive continuous improvement in design quality processes. Collaborate with cross-functional teams (R&D, Regulatory, Manufacturing, and Post-Market). Qualifications Bachelor’s degree in Mechanical Engineering or related field. 7+ years’ experience in Design/Development Quality in the medical device industry. Strong understanding of ISO 13485, ...

JOB TITLE: Medical Device Regulatory Compliance Specialist JOB SUMMARY: We are seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to play a critical role in ensuring our medical device development processes meet the highest standards of quality and regulatory compliance. The ideal candidate will have hands-on experience with technical documentation, quality systems, and regulatory submissions, and will play a key role in ensuring product safety and compliance throughout the development lifecycle, specifically focusing on the Design History File (DHF) and Device Master Record (DMR). RESPONSIBILITIES: Support the preparation and maintenance of USFDA and EU MDR-comp...

Job Title: QARA + SaMD Specialist (Contract Role) Company: Aegan Technologies Locations: Pune | Chennai | Bangalore | Mumbai | Hyderabad Experience: 3 to 10 Years Join Within: 15 Days Job Description: Aegan Technologies is hiring experienced QARA + SaMD Specialists for a contract-based opportunity. The ideal candidate will be responsible for managing regulatory strategies, ensuring compliance with global standards (FDA, EU MDR, ISO, IEC), and maintaining QMS and DHF documentation for software-based medical devices. Key Responsibilities: Manage regulatory and quality processes for medical devices & SaMD. Ensure compliance with FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 82304 & EU MDR. Prep...

Job Title: Senior Design Engineer Mechanical Location: Gurugram, India Work Flexibility: Hybrid Department: Mechanical Engineering Employment Type: Full-time, Regular About the Role The Senior Design Engineer Mechanical will be responsible for the design, development, and verification of components and modules for medical devices. The role involves translating design inputs into detailed engineering specifications and developing innovative technical solutions through prototyping and analysis. This position suits an experienced engineer with a strong background in mechanical design within the medical device industry, particularly in cardiovascular or endovascular domains. Key Responsibilities...

Job Title: Senior Design Engineer Mechanical Location: Gurugram, India Work Flexibility: Hybrid Department: Mechanical Engineering Employment Type: Full-time, Regular About the Role The Senior Design Engineer Mechanical will be responsible for the design, development, and verification of components and modules for medical devices. The role involves translating design inputs into detailed engineering specifications and developing innovative technical solutions through prototyping and analysis. This position suits an experienced engineer with a strong background in mechanical design within the medical device industry, particularly in cardiovascular or endovascular domains. Key Responsibilities...

Role Overview: You will be responsible for applying your mechanical engineering expertise to contribute to the design and development of medical devices. Your role will involve ensuring compliance with design controls and managing design changes effectively. Your proficiency in risk management, DFMEA, and design documentation will be crucial for the success of the projects. Key Responsibilities: - Hold a Bachelor's or Master's degree in Mechanical Engineering - Have hands-on experience with medical device design control - Demonstrate experience in mechanical product design and development - Proficient in design change management, design documentation, risk management, and DFMEA - Familiarity...

Role & responsibilities Experience : 5+yrs Location: Preferably Mysore/ Ok for Bangalore Mandate skills: reliability test Medical Device JD: - Develop and execute reliability test plans (e.g., accelerated life testing, HALT/HASS, stress testing) - Conduct Failure Mode and Effects Analysis (FMEA) and root cause investigations - Collaborate with R&D to integrate reliability into product design - Analyze test data using statistical methods (Weibull, ANOVA, DOE) - Maintain and update Design History Files (DHF) and risk documentation per FDA and ISO standards - Ensure compliance with ISO 13485, ISO 14971, and FDA 21 CFR 820.30 - Support design verification and validation activities - Provide tech...

Purpose of the role: The Design Lead will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance. Roles & Responsibilities: Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366). Participate in design reviews and provide quality engineering support throughout the product development lifecycle. Establish and maintain Design History Files (DHF) and...

Role Overview: As a Design Quality Engineer at Boston Scientific, you will be responsible for developing, establishing, and maintaining quality engineering methodologies to meet BSC, customer, and regulatory requirements. You will play a crucial role in improving awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. Your primary focus will be providing quality engineering support within new product development, operational, or system/services support. Key Responsibilities: - Participate in sustaining project teams and contribute to design quality engineering throughout the entire prod...

Educational Requirements Master Of Engineering,MTech,Bachelor of Engineering,BTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide y...

Job Discretion: JL 5 - Sr Associate role - Electrical or Mechanical Engineering with 5+ years of experience . 3+ relevant years of experience in Design Control of Medical Devices . Life cycle management, making decisions in change management. Change management - Cost reduction, process improvement. Regulatory affairs MDR to EMUDR , follow the regulatory & statutory requirements Work with cross functional teams. Excellent written & verbal communication. Act as project lead – coordinate with different teams - Design Control , MTO, Service, Regulatory Affairs . Team lead experience. Good to have experience in ophthalmology . Consumables and Accessories experience. People with experience in Ster...

Role/Summary: Collaborate with cross-functional teams to identify and assess risks associated with medical device development and integrate risk management activities into the V&V process, ensuring that potential hazards and risks are adequately addressed and mitigated in accordance with ISO 14971. Utilize risk-based testing methodologies to prioritize V&V activities based on the level of risk associated with medical devices. Evaluate the effectiveness of risk controls and mitigation strategies through V&V testing activities. Develop verification and validation protocols and test plans based on product requirements, design specifications, and regulatory standards. Document and maintain compr...

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)

Educational Requirements Master Of Engineering,MTech,Bachelor of Engineering,BTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide y...

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...

Additional Locations: India-Haryana, Gurgaon Diversity Innovation Caring Global Collaboration Winning Spirit High Performance At Boston Scientific, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges With access to the latest tools, information and training, well help you in advancing your skills and career Here, youll be supported in progressing whatever your ambitions, Key Responsibilities Read and interpret technical drawings, procedures, and protocols, Import and maintains the project documentation in online RM tool throughout all phases of NPD and Sustai...

Develop & operate the Pilot plant from the R&D lab trial data till Commissioning of the Plant setup Ensure the production plant is working within the targeted norms, Safety & quality scales Continue implementation of IMS & PSM practices of the plant Required Candidate profile BE CHEMICAL ENGG 3+yrs exp into MAINT/NEW PROJECTS/NPD/ROCESS with CHEMICAL Unit Exposure in HYDRO FLURIC ACID, HYDROFLUOROCARBON REFRIGERANTS, SPECIALTY ORGANIC FLUORIDES etc ++++ Work @ CUDDALORE Perks and benefits cv.ch1@adonisstaff.in Call @ 9677076683 now

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...

As a Design Quality Engineer at our company, your primary responsibility will be to develop, establish, and maintain quality engineering methodologies, systems, and practices that align with BSC, customer, and regulatory requirements. You will serve as a Quality representative to enhance awareness, visibility, and communication on quality initiatives, supporting departmental, functional, site, divisional, and corporate quality goals and priorities. Your role will involve providing focused quality engineering support within new product development, operational, or system/services support. In this position, you will collaborate with sustaining project teams and engage in design quality enginee...

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.

Develops, establishes and maintains quality engineering methodologies, systems,practices which meet BSC,customer,regulatory requirements. Serves as a Quality representative to improve awareness,visibility,communication on quality initiatives Required Candidate profile Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

Job Title: Senior Design Engineer Reports to: D&D Head Job Summary: The Senior Design Engineer will lead the design and development of innovative medical devices, ensuring compliance with regulatory and industry standards. This role involves mentoring junior team members, managing complex design projects, coordinating with cross-functional departments, and preparing comprehensive design documentation for regulatory submissions. The candidate must have a strong understanding of manufacturing processes, regulatory expectations, and design control principles. Key Responsibilities: 1. Design & Product Development Lead the design and development of new products and improvements to existing device...

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Co...