- Meta (New York, NY)
- …for software as a medical device (SaMD) programs. **Required Skills:** Medical Devices , Design Assurance Engineer Responsibilities: 1. Lead and ... **Summary:** We are seeking an experienced medical devices quality management systems professional...execute design control activities for medical device projects, ensuring compliance with regulatory… more
- Abbott (Burlington, MA)
- …are seeking an experienced Staff Engineer, Software Design Quality to ensure our medical devices are developed in accordance with Abbott's design control ... of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines....ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience… more
- Insight Global (Maple Grove, MN)
- …field; Master's preferred. . Minimum of 5 years of experience in design assurance within the medical device industry. . In-depth understanding of ... Job Description Insight Global is looking for a talented Senior Design Assurance Engineer to join our innovative team. This role involves ensuring that our… more
- Terumo Medical Corporation (Elkton, MD)
- …Dec 8, 2025 Req ID: 5357 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: TIS Design Assurance /Quality Engineering **Job Summary** ... and statistics skills + Demonstrated working knowledge of key medical device related standards including 21 CFR... related standards including 21 CFR 820 (Quality Systems Medical Devices ), Design Controls, ISO… more
- DEKA Research & Development (Manchester, NH)
- …Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, design assurance , manufacturing, and distribution environment. How ... the best approach. + Use experience within Design Assurance or production and processing of medical devices to provide guidance and assistance in the… more
- Actalent (Maple Grove, MN)
- …in cleanroom environments with bovine pericardium. Additional Skills & Qualifications + Knowledge of medical device design assurance , design control, ... understands GMP requirements for the manufacture of a sterile medical device . Responsibilities + Execute lab-based process...Essential Skills + 3-5 years of experience in quality assurance , with a strong preference for experience in structural… more
- Actalent (Franksville, WI)
- …+ Lead and manage critical activities to maintain and improve electro-mechanical medical device design , manufacturing, and service processes. + ... Description Lead the development of electromechanical medical device products, overseeing the process from design ... device products, overseeing the process from design through to systems and quality assurance .… more
- Amazon (Seattle, WA)
- Description Shape the future of Amazon's device offerings by leading UX design strategy across our most complex, cross-platform experiences. As a Principal UX ... and Alexa to Fire TV, Kindle, and emerging connected devices . You'll be the design leader defining...device product lines. Our work spans analytics platforms, device management tools, quality assurance systems, and… more
- Hologic (Newark, DE)
- Lead Design Assurance Engineer Newark, DE, United States Marlborough, MA, United States Are you passionate about driving innovation while ensuring compliance and ... quality in medical device development? At Hologic, we are seeking a **Lead Design Assurance Engineer** to play a pivotal role in new product development,… more
- Hologic (Newark, DE)
- …ability to lead design assurance efforts for software in medical devices , ensuring compliance and safety throughout the product lifecycle. + Expertise ... about ensuring the quality, safety, and reliability of life-saving medical device software? Hologic is seeking a...device software? Hologic is seeking a **Lead Software Design Assurance Engineer** to play a critical… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Manager, Medical Device Quality Assurance position on our Medical Device Sustaining Engineering QA team. This ... Design Reviews associated with combination products and/ or medical devices + Maintain the quality risk... Assurance and Quality Risk Management in the medical device /combination products field + Possess excellent… more
- Hologic (Marlborough, MA)
- …life-changing medical devices ? At Hologic, we are seeking a **Lead Design Assurance Engineer** to provide strategic and technical leadership in design ... Lead Design Assurance Engineer Newark, DE, United...and EU MDR (Regulation 2017/745). + Advanced understanding of medical device standards, including usability, reliability, electrical… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …all quality activities related to the design , development, and transfer of medical devices to manufacturing. This role ensures compliance with all applicable ... **Job Responsibilities:** + Lead and manage a team of Design Assurance engineers, providing guidance, mentorship, and...+ Minimum of 8 years of experience in Quality Assurance within the medical device … more
- J&J Family of Companies (Malvern, PA)
- …+ Own technical decisions related to mechanical, electromechanical, and connected- device design , ensuring performance, reliability, and patient usability. ... **Regulatory & Quality:** + Ensure compliance with global combination product and medical device regulations. + Provide engineering leadership during regulatory… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … design validations + Reviewing activities related to Design Verification and Design Transfer of Medical Devices + Ensuring work product meets ... looking to fill a Quality Engineer position on the Medical Device Sustaining Engineering QA team. This...+ Reviewing technical reports as well as documents for Design History Files + Participating in device … more
- AbbVie (North Chicago, IL)
- …clinical safety input to new product design teams as needed. The Medical Device Safety Physician is independently responsible for proactive safety strategy, ... to other AbbVie office locations in the US. Purpose: Medical Device Safety Physician leads the safety...on safety related issues. + Responsible for overall evaluation, assurance , and reporting of safety of subjects in clinical… more
- Philips (San Diego, CA)
- …indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software. + Serving as SME ... **Sr. Software Design Assurance Engineer** **In this role...of experience in Software Quality and/or Software Development in medical device industry with hands on experience… more
- Hologic (Louisville, CO)
- …a visionary leader with a passion for ensuring the highest standards of quality in medical device design and development? We are seeking a dynamic **Director ... Director, Design Assurance Newark, DE, United States...especially Design Control requirements, ISO 13485, and Medical Device Directive. + Familiarity with ISO… more
- Integra LifeSciences (Mansfield, MA)
- …* Working knowledge of DFSS techniques * 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development * Fluent ... * 8 years of experience of working within a Medical device or other regulated industry with...supervision. * Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals… more
- Philips (Plymouth, MN)
- …You have a minimum of 5+ years' experience in FDA regulated medical device environments, with a focus on Design Assurance /Control, detailed knowledge of ... The Senior Design Assurance Engineer will play a...Design /Process Controls. + You have strong understanding of Medical Device QSR regulations/standards including ISO 13485,… more