- ConvaTec (Lexington, MA)
- …to 10 years of clinical trial management experience in conducting and leading global medical device clinical trials, preferably with a sponsor company. + Solid ... understanding of the device development process, ICH guidelines/GCP and specifically, each step...functional team members including, but not limited to, regulatory, R&D , project/program management, data management, and medical … more
- Fresenius Medical Center (Lawrence, MA)
- …a constructive approach teamwork and collaboration. + Demonstrated interest in medical device or pharmaceutical industries. + Excellent technical communication ... 2026, ending in June 2026.** **INVENT. IMPROVE. INSPIRE.** Fresenius Medical Care, a global leader in renal care, offers...'s new and existing products. As part of the R&D team, this involves participating in testing, design, building… more
- Hologic (Marlborough, MA)
- …Management), and EU MDR (Regulation 2017/745). + Advanced understanding of medical device standards, including usability, reliability, electrical safety, and ... As a subject matter expert, you will partner with R&D , Regulatory Affairs, and Manufacturing Engineering teams to embed...Assurance, Quality Engineering, or related technical roles within the medical device industry with a Bachelor's degree… more
- Medtronic (Newton, MA)
- …electrophysiology lab. + At least 2 years of product development experience within the medical device or another regulated industry. + Ability to perform simple ... Core Team Member** and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you'll work alongside a team of engineers… more
- Hologic (Marlborough, MA)
- …& Attributes:** + Working knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP. + ... required for implementation. + Provide post-market feedback to Operations, Engineering, and R&D to improve device design and manufacturing. + Conduct field… more
- J&J Family of Companies (Danvers, MA)
- …at https://www.jnj.com/medtech **Responsibilities:** + Design, development, and test software per medical device software development life cycle (IEC-62304) + ... health for humanity. Learn more at https://www.jnj.com **Job Function:** R&D Product Development **Job Sub** **Function:** R&D ...would be a big plus. + Experience in the medical device industry is strongly preferred. +… more
- Hologic (Marlborough, MA)
- …teams in the execution of design changes, product enhancements, and quality projects for medical device products. This position plays a vital role in ensuring ... engineering principles, analysis, and empirical methods. + Collaborate with R&D , PQE, and RA teams to maintain compliant risk...experience, with a preference for 3 years in a medical device process and/or product development environment.… more
- Pfizer (Cambridge, MA)
- …and optimally coordinated + Serve as key partner for Internal Medicine R&D , US Commercial, and other key functional stakeholder, regularly communicating the ... and actions; and status of competitor products + Partners with leaders in R&D and Commercial teams to develop strong global regulatory strategies for projects and… more
- Sanofi Group (Northborough, MA)
- …regulations related to manufacture of medical devices as well as medical device development (design control), risk management process (according to ISO ... the involvement of design control and risk management SMEs. + Responsible for medical device release in accordance with approved specifications and procedures.… more
- Kelly Services (Raynham, MA)
- **CER Technical Writer** The CER Technical Writer must have experience within the medical device industry and knowledge of clinical evaluation report regulatory ... Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D , Clinical Affairs and Regulatory Affairs relating to the...is required for this position + Experience within the medical device industry and knowledge of clinical… more