- Olympus Corporation of the Americas (Westborough, MA)
- …matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, including IEC ... product delivery while maintaining compliance and quality. + Provide project management oversight for QMS integration, Quality plans, process...+ Minimum of 6 years of experience in a medical device setting. + Experience in the… more
- Intertek (Boxborough, MA)
- Project Engineer - Medical Device Testing, Boxborough, MA Intertek, a Nationally Recognized Testing Lab (NRTL) and leading provider of quality and safety ... the top recognized brands and companies is actively seeking a Project Engineer - Medical Device Testing to join our Electrical team in Boxborough, MA.… 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...with medical device and combination device regulations. + Lead project execution activities… more
- Hologic (Marlborough, MA)
- …Are you passionate about ensuring the quality, safety, and reliability of life-saving medical device software? Hologic is seeking a **Lead Software Design ... Lead Software Design Assurance Engineer Marlborough, MA, United States Newark, DE, United...excellence in software development for both Software as a Medical Device (SaMD) and embedded systems (SiMD).… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …pacemakers or low-level analog signal equipment would be a strong plus + Familiarity with medical device safety agency approval processes such as UL or ETL a ... that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide...subsystems. May act in the role of lead electrical engineer (Task Leader) within a development team, group, or… more
- Hologic (Marlborough, MA)
- …Are you passionate about driving innovation while ensuring compliance and quality in medical device development? At Hologic, we are seeking a **Lead Design ... Lead Design Assurance Engineer Newark, DE, United States Marlborough, MA, United...to hear from you! **Knowledge:** + In-depth understanding of medical device regulations and standards, including ISO… more
- Celestica (Merrimack, NH)
- …Celestica product design partners. + Understanding ISO 13485 requirements for medical device engineering changes. **Knowledge/Skills/Competencies** + An "out of ... and key characteristics that allow for substitution. + Understanding of IEC 60601-1 Electrical Medical Device Safety Standard. + Understanding of ISO 13485 as it… more
- Celestica (Merrimack, NH)
- …Hampshire City: Merrimack **General Overview** **Job Title: Staff Software Engineer (BSP/Diag/SDK)** **Functional Area:** Engineering (ENG) **Career Stream:** Design ... SEN-ENG-DSE **Job Band:** 10 **Direct/Indirect Indicator:** Indirect **Summary** The Staff Engineer , Software develops, debugs, tests, deploys and supports code to… 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. + ... Post Market Quality Engineer Newark, DE, United States Marlborough, MA, United...quality and ensuring the safety and effectiveness of life-changing medical devices? Join Hologic's Breast and Skeletal Health Division… 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 ... experience, with a preference for 3 years in a medical device process and/or product development environment....Medical Devices Directive. + Effective team leadership and project management skills. + Strong knowledge of root cause… more
- Celestica (Merrimack, NH)
- …Contributor **Direct/Indirect Indicator:** Indirect **Summary** The Senior Lead Engineer , Software shall be responsible for developing, debugging, validating ... background in NOS architecture, L2/L3 protocol development. The Senior Lead Engineer , Software works in cross functional teams with other designers, customers,… more
- Celestica (Merrimack, NH)
- …Experience in NOS development/sustenance. + Platform Bring-up (Including implementing Linux Device drivers), Stacking, High Availability etc, + Project ... Country: USA State/Province: New Hampshire City: Merrimack **Summary** The Senior Staff Engineer , Software develops, debugs, tests, deploys and supports code to be… more
- Hologic (Marlborough, MA)
- …field required; Master's preferred. + Extensive understanding of engineering principles, medical device development, and customer-centric design. + Advanced ... Sr. New Product Development Engineer - Marlborough, MA Marlborough, MA, United States...in documentation and deliverables. **Experience** + 5+ years in medical device product development with a Bachelor's… more
- Jacobs (Hudson, NH)
- …and as-built processes; verify construction install with model based practices; create project processes and lead mobile device trainings for field employees; ... are seeking an experienced Virtual Design & Construction (VDC) Engineer to manage and optimize our digital delivery processes...and client goals and define digital delivery scope for project estimates, and coordinate project technical setup… more
- Celestica (Merrimack, NH)
- …Contributor **Direct/Indirect Indicator:** Indirect **Summary** The Senior Lead Software Engineer designs, develops, and maintains software across all levels ... robust, high-quality product development. Celestica is looking for a dynamic software engineer who is passionate about working closely with the HW/SW interface to… more
- Hologic (Marlborough, MA)
- …+ In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive. + Expertise in compliance issues and regulatory ... Principal Quality Assurance Engineer Marlborough, MA, United States Louisville, CO, United...and compliance. **Experience:** + Minimum 12+ years in the medical device industry. + Proven track record… more
- Fresenius Medical Center (Waltham, MA)
- …cache (eg Redis) + Experience working in a highly regulated industry, medical device preferred. + Experience and knowledge of cybersecurity methodologies ... the design, development, testing, and/or support of web-based software for NxStage Medical 's products. **Specific Duties:** + Design, develop, code and unit test… more
- Hologic (Marlborough, MA)
- …with Bachelor's, 6+ years with Master's) in new product development within the medical device industry. + Deep clinical and technical knowledge in gynecological ... New Product Development (NPD) Engineer ** Are you passionate about driving innovation in medical devices? Join our team as a Lead NPD Engineer , where your… more
- AbbVie (Worcester, MA)
- …21 CFR Part 11 requirements for automated systems in the pharmaceutical or medical device industries. + Demonstrated problem solving skills and innovative ... medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's… more
- Hologic (Marlborough, MA)
- …particularly Design Control requirements. + In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). + Familiarity ... and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role,… more
