112 Design Control Jobs

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...

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. Frequent interorganization contacts on technical matters often requiring coordination between organizations Job Description Leads or assists in the development of, and continuous improvement of, quality systems for R&D in compliance with 21 C...

As a Regulatory Affairs Professional specializing in biosimilar combination products at Dr. Reddys Laboratories Ltd., your role involves developing and executing global regulatory strategies for combination product devices. Your responsibilities include ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. You will provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. Additionally, you will lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. It is crucial to ensure accurate regulatory d...

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...

Develop and expand the dealer/distributor network to strengthen market reach. Identify new business opportunities with OEMs, modular furniture manufacturers, and project clients. Conduct regular market visits to monitor competitor activities, pricing, and new product trends. Manage, motivate, and support channel partners to enhance sales performance. Ensure distributor ROI, stock planning, timely replenishment, and healthy inventory levels. Build and maintain strong relationships with architects, interior designers, contractors, and carpenters. Conduct presentations, product demos, and technical sessions for influencers. Implement promotional schemes, campaigns, and branding initiatives as p...

Role & responsibilities Overall exp- 5- 7 Years Open Positions- 2 Any domain specification- SaMD QARA Expertise, Design Control, DHF and EU MDR. Qualification Criteria- BE/BTECH Mandatory Skills- SaMD design control documentation authoring/reviewing Work location- Bangalore/Mysore Details JD- BE/BTECH with software background Experience in design control documentation for FDA and EUMDR. SaMD expertise for design control activities. Good communication skills as required to connect with customer SPOC for the day-to-day activities.

Hands on experience in architecting and Designing control/ Ignition SCADA systems including databases and database interfaces, Tag Providers, Ignition Python Scripting Knowledge and expertise for ignition Manufactuing domain experience

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 One of BD's most profitable platforms Peripheral Intravenous Catheters (PIVC) is looking for an energetic Program Manager who can help manage several projects to sustain, improve profitability, or ensure compliance to new standards and regulations for a large portfolio of products. The successful candidate will be part of MDS PIVC PMO organization, reporting into the PIVC PMO Director. The position is located in BD's Technology Campus India site. The Program Manager will have to manage the multi-functional activities of the projects, lead the cross functional team (R&D, Supply Chain, Marketing, Quality, MA, Regulatory etc.), and own and execute the Design Change Plan....

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 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. 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 improvemen...

Job Description Summary This role is created as additional headcount to support Neo project. Job Description Job Description number: TCI-JD025 Reporting To: Staff Quality Engineer / Quality Manager Position Title: Senior Quality Engineer Job Group: JG3 Department /Segment: Quality Engineering / BD Medical Location: Bengaluru, India About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has ...

Job Description Summary This role is created as additional headcount to support Neo project. Job Description Job Description number: TCI-JD025 Reporting To: Staff Quality Engineer / Quality Manager Position Title: Senior Quality Engineer Job Group: JG3 Department /Segment: Quality Engineering / BD Medical Location: Bengaluru, India About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has ...

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...

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...

Job Description Summary Job Description Job Description number: TCI-JD025 Reporting To: Staff Quality Engineer / Quality Manager Position Title: Senior Quality Engineer Job Group: JG3 Department /Segment: Quality Engineering / BD Medical Location: Bengaluru, India About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the...

This job is with Danaher, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. 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 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. At Radiomete...

Job Description Summary Job Description Job Description number: TCI-JD025 Reporting To: Staff Quality Engineer / Quality Manager Position Title: Senior Quality Engineer Job Group: JG3 Department /Segment: Quality Engineering / BD Medical Location: Bengaluru, India About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD has 70,000 employees and a presence in virtually every country around the...

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Togethe...

Administer and maintain SolidWorks PDM system for design file management across Cepheid, ensuring version control and access compliance Validate synchronization between SolidWorks PDM designs and documentation released in Cepheid s Quality Management System (QMS) Troubleshoot and resolve SolidWorks and PDM-related technical issues, including root cause analysis and corrective actions Manage engineering software licenses and monitor server performance metrics to ensure optimal uptime and resource utilization Develop and maintain standardized drawing templates, part libraries, and design documentation; conduct empirical studies including protocol execution, data analysis, and reporting of engi...

Role Overview: As the Lead Quality Engineer, you will be responsible for supporting new product development and product maintenance for medical devices by applying your Quality engineering skills. You will be involved in handling projects from product inception through launch and maintenance, ensuring that products meet quality standards in alignment with Corporate and unit policies, as well as regulatory requirements. Key Responsibilities: - Support design control projects. - Write and lead risk management activities. - Assist in creating specifications, design, and test methods for new products. - Translate customer needs into engineering requirements for product, packaging, and process sp...

Key Responsibilities Review and approve design control documentation across all phases, ensuring complete traceability and alignment with requirements, risk controls, and applicable regulations & standards. Execute DHF and QMS migration activities. Execute DHF and QMS migration activities. Ensure design documentation, risk management files, and verification/validation reports comply with regulatory and quality system requirements. Review and approve design control documents, ensuring traceability to requirements and standards. Support Design History File (DHF) remediation and document consolidation efforts. Collaborate closely with development teams to ensure design control requirements are ...

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...