- Cytiva (Shrewsbury, MA)
- …of experience in Quality or Regulatory in a regulated industry (ISO 9001, medical device , or pharmaceutical preferred).Experience with root cause analysis, CAPA ... about the Danaher Business System which makes everything possible.The Quality Assurance Engineer ( Design & Manufacturing) is responsible for providing quality… more
- Amgen (Cambridge, MA)
- …transform the lives of patients while transforming your career. Engineer I - Medical Device Design Control Documentation Specialist **What you will do** ... + Provide direction and support for all technical documentation ( Device Design /Testing, Design Outputs, Manufacturing...- ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EECStrong… more
- Actalent (Waltham, MA)
- Responsibilities: + Design and develop production build and test fixtures for complex electromechanical subsystems for production volumes. + Create fixture ... requirements, design descriptions, use, and preventive maintenance documentation. + Perform...R&D engineering experience, with at least 5 years in medical devices. + Bachelor's degree in Mechanical, Robotics, or… more
- Takeda Pharmaceuticals (Lexington, MA)
- …support lifecycle management of commercial combination product. The Staff Device Engineer has extensive experience in medical devices for drug delivery ... of my knowledge. **Job Description** **Primary** **Role:** The Staff Device Engineer will lead technical efforts for...of design control deliverables to comply with medical device and combination device … more
- Sanofi Group (Cambridge, MA)
- **Job title** : Associate Principal Device Engineer **Location:** Cambridge, MA **About the Job** We deliver 4.3 billion healthcare solutions to people every ... and their families. The strategic vision of Sanofi's Global Medical Device and Packaging organization is to...continued success to accomplish our missions. As Associate Principal Device Engineer , Early Stage Programs you will… more
- Actalent (Newton, MA)
- Job Title: Senior Manufacturing Fixture Design Engineer Job Description The Senior Manufacturing Fixture Design Engineer will be a part of the R&D ... testing, process validation, and transfer to manufacturing within a regulated medical device development environment is essential. Responsibilities + Be… more
- Actalent (Newton, MA)
- …Experience in the design , qualification, and verification of fixtures for medical device assembly and testing. + Expertise in electromechanical system ... Job Title: Fixture Design Engineer Job Description The Senior... medical devices and disposables within a regulated medical device development environment. Responsibilities + Act… more
- Actalent (Waltham, MA)
- …Experience in the design , qualification, and verification of fixtures for medical device assembly and testing. + Expertise in electromechanical system ... Position Summary: The Sr. Manufacturing Fixture Design Engineer will play a crucial...process validation, and transfer to manufacturing within a regulated medical device development environment. Key Responsibilities: +… more
- Abbott (Burlington, MA)
- …of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (eg, 62304), EU Medical Device Regulations and MDSAP + Experience with medical ... medical devices are developed in accordance with Abbott's design control requirements and state of the art standards.... Design Quality Department, provide oversight of R&D design control deliverables for development of medical … more
- Medtronic (Newton, MA)
- …work directly with some of the industry's prominent experts in the field of medical device engineering in a fun and collaborative office environment. The ideal ... annotating 3D regions where ablation energy is delivered. As a Principal Hardware Engineer , you will be developing the next generation technology for treatment of… more
- Integra LifeSciences (Boston, MA)
- …related discipline with 5+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years of ... and set new standards of care. The Senior Quality Engineer I - Design & Reliability Assurance...collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs. Support Design Reviews, Technical Reviews,… more
- Actalent (Newton, MA)
- …assemblies, from prototype to verification builds, within a regulated medical device environment. Responsibilities + Lead the design of complex DV fixtures ... Job Title: Senior ElectroMechanical Design Engineer Job Description The Senior...related field. + Experience in heavily-regulated industries such as medical device or aerospace. + Hands-on experience… more
- Teleflex (Chelmsford, MA)
- …of quality engineering or design assurance experience (preferably in the medical device industry). **Specialized Skills / Other Requirements** * ASQ ... Quality Engineer II, Design Assurance (Contract Role-...:11809 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- Kelly Services (Marlborough, MA)
- …designing, developing, and manufacturing plastic disposable kit products for regulated industry ( medical device , class II and/or class III)._ + **Duration** : ... ** Design Verification and Validation (V&V) Engineer **...scientific fields (mechanics, micro-mechanics, materials ). + Experience with medical device risk management and risk analysis… more
- Integra LifeSciences (Mansfield, MA)
- …on our range of Neurosurgical Medical Devices and lead a team of Quality Engineer . Working in the Design Quality team, you should excel in an environment ... and set new standards of care. The Staff Quality Engineer will work within the Integra Lifesciences CSS Quality...technical situations are required + Previous experience in a medical device or a healthcare discipline is… more
- Integra LifeSciences (Boston, MA)
- …related discipline, with 3+ years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing, or equivalent education and years ... pathways to advance patient outcomes and set new standards of care. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the… more
- Philips (Cambridge, MA)
- …with full working knowledge of 21 CFR 820, ISO 13485 and ISO14971 medical device /safety requirements. Strong knowledge/experience with CAPAs, NCRs and product ... We're looking for a highly qualified Senior Design Assurance Engineer (sustaining) to join...You have a bachelor's degree in engineering (electrical engineering, bio- medical engineering) with a minimum of 5 years of… more
- Actalent (Waltham, MA)
- Position Summary: The Senior ElectroMechanical Design Engineer will be an integral part of the R&D organization, contributing significantly to the development of ... assemblies, from prototype to verification builds and testing within a regulated medical device development environment. Ideal candidates will have experience in… more
- Meta (Boston, MA)
- …on the web. We are hiring in multiple locations. **Required Skills:** Software Engineer , Systems ML - SW/HW Co- design Responsibilities: 1. Apply relevant AI ... **Summary:** Meta is seeking an AI Software Engineer to join our Research & Development teams....2. Goal setting related to project impact, AI system design , and infrastructure/developer efficiency 3. Directly or influencing partners… more
- Danaher Corporation (Shrewsbury, MA)
- …if you also possess previous experience in: + Experience in the Bio-Science, Medical Device , or Pharma industries. + Project Management Professional (PMP) ... Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Lead Design Transfer Engineer coordinates resources across teams… more
