Regional Lead Quality Engineer CSL Behring LLCRegional Lead Quality EngineerWaltham, MA$143,000–$169,000 / yearThe Medical Device and Packaging QA Staff (Advisor) should have minimum 2 years practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation / verification (V&V), usability / human factor studies, DHFs, design transfer. This role assures product development and site level execution of the local CP/MD Quality System for combination products to govern quality related business processes throughout the entire combination product lifecycle, with emphasis on the new product development activities.
Sensor Intelligence Engineer II (Advanced Development) WhoopSensor Intelligence Engineer II (Advanced Development)Boston, MASuccess in this role will require a deep understanding of physical sensing mechanisms, for example electrical, optical, or thermal, and development of the signal processing and algorithms needed to translate raw data into actionable feedback. WHOOP is looking for an Engineer II to join the Sensor Intelligence Group (SIG), a cross-functional team collaborating across Hardware, Firmware, and Data Science.
NewEngineer I, Process Development, Pilot Scale Operations ModernaTXEngineer I, Process Development, Pilot Scale OperationsNorwood, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Qualified candidates will have relevant academic or industry experience in solution preparation, RNA processing, sterile fill/finish and/or tangential flow filtration experience, and an understanding of scaling and technology transfer of these unit operations.
Packaging/Medical Device Quality Engineer CSL Behring LLCPackaging/Medical Device Quality EngineerWaltham, MA$115,000–$136,000 / yearAs a part of the Quality for Combination Products and Medical Devices (CP/MD QA) department, the Combination Product and Medical Device and Packaging QA Associate will represent Quality in global teams involved in design, development, manufacture and regulatory approval of CSL combination products, which include medical device constituent parts developed to enable convenience, monitoring, compliance and effective outcomes for the lives of our patients. The Medical Device and Packaging QA Staff (Advisor) should have minimum 2 years practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation/verification (V&V), usability / human factor studies, DHFs, design transfer.
Senior Quality Engineer In Vitro Diagnostics SanofiSenior Quality Engineer In Vitro DiagnosticsCambridge, MA$133,500–$192,833.33 / yearEnd-to-End Lifecycle Quality: Provide quality leadership across assay development, validation, design transfer, commercialization, and lifecycle management, ensuring compliance with design controls and maintaining traceability from intended use and user needs through verification, validation, risk management, clinical evidence, and labeling. IVD Regulatory Compliance: Provide strategic quality leadership across IVD development, evidence generation, labeling, regulatory strategy, and lifecycle management, ensuring compliance with FDA and international regulatory requirements, including EU IVDR, ISO 18113, and 21 CFR Part 809.
Engineer I, Process Development ModernaTXEngineer I, Process DevelopmentNorwood, MassachusettsWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Qualified candidates will have relevant academic or industry experience in solution preparation, lipid nanoparticle, sterile fill/finish and/or tangential flow filtration experience, and an understanding of scaling and technology transfer of these unit operations.
Senior Scientist / Senior Engineer, LNP Process Development Prime Medicine, Inc.Senior Scientist / Senior Engineer, LNP Process DevelopmentCambridge, MA$145,000–$161,000 / yearLead the design, execution, and optimization of LNP processes to accommodate novel formulations and drug product manufacturing processes (LNP mixing and tangential flow filtration [TFF]) from bench through GLP/GMP scale, with emphasis on developing robust and scalable processes. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.
Bioinstrumentation Support Engineer Spear BioBioinstrumentation Support EngineerWoburn, MassachusettsDevelop working proficiency in SPEAR assay workflows (sample preparation, plate setup, qPCR readout, SPEARview data analysis) sufficient to troubleshoot workflow failures at customer sites and distinguish instrument issues from assay/reagent issues. Because this role is tightly aligned with engineering, you will be expected to go deeper than a traditional FSE—diagnosing root causes across hardware, software, and assay workflows—and bringing that knowledge directly to customers and back to the team.
Research Manufacturing Engineer II Boston Children's HospitalResearch Manufacturing Engineer IIBoston, MA$62,212.80–$99,528 / yearPrimary responsibilities include driving improvements to the CORT QMS, overseeing and ensuring compliance with the CAPA, NC and Quality Planning processes, and providing experienced quality assurance support to manufacturing and product development teams. Drive continuous improvement initiatives using quality tools and methodologies such as Lean, Six Sigma, Poka-Yoke, and data analysis, while supporting special projects and inventory-related quality activities.
Field Service Engineer, East Coast Stellaromics IncField Service Engineer, East CoastBoston, MAOur pioneering proprietary technology helps researchers and clinicians create comprehensive cellular maps enhancing our understanding of various diseases, with our flagship product STARmap and upcoming Pyxa suite of products. We have a passionate management team and committed investors who believe in our patented technology and overall mission to profoundly advance biomedical research and accelerate the discovery of life-saving treatments.
Senior Manager, Hardware Engineer, OLYSENSE Olympus CorpSenior Manager, Hardware Engineer, OLYSENSEWestborough, MADevelop hardware engineering capabilities, infrastructure, and external partnerships, including laboratory and test capabilities, prototype configuration management, supplier/OEM relationships, contract manufacturing interfaces, external engineering partners, and test laboratories required to support development, qualification, production, troubleshooting, and lifecycle management. Lead cross-functional product development, production transfer, and lifecycle sustainment, partnering with Software, AI, Systems Engineering, Product Management, Quality, Regulatory, Operations, Purchasing, Suppliers, Contract Manufacturers, Service, and external laboratories to ensure product readiness, compatibility, reliability, manufacturability, and serviceability.
Senior Product Engineer, Post Processing - Aerospace & Defense VulcanFormsSenior Product Engineer, Post Processing - Aerospace & DefenseDevensDesign, develop, and implement fixtures and work-holding for process and part-handling steps such as depowdering, EDM, heat treatment, support removal, machining, assembly, cleaning, marking, and finishing -including prototype fixtures, whose manufacture you will oversee. You will define the processes, procedures, work instructions, and systems that produce our components and sub-assemblies to customer specification, drawing on product design, fabrication, assembly, work-holding, cutting tools, and materials expertise.
NewAssociate Product Development Engineer VulcanFormsAssociate Product Development EngineerDevens, MA$68,000–$94,000 / yearWorking under the direction of senior engineers, you will support continuous improvement of the production line, applying advanced manufacturing techniques, automation, and lean manufacturing methods to develop optimized production processes. As an Associate Product Engineer, Medical Devices at VulcanForms, you will help define and execute the manufacturing processes that take our printed parts from the build plate to a finished, inspected product.
NewSenior Product Systems Engineer VulcanFormsSenior Product Systems EngineerDevens, MA$100,000–$137,000 / yearFounded in 2015 to develop the world's first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. You will design the systems, procedures, and data infrastructure that let product move seamlessly through the plant, and you will mentor the product engineers who build and maintain the part-level processes within them.
Staff Product Development Engineer - Aerospace & Defense VulcanFormsStaff Product Development Engineer - Aerospace & DefenseDevens, MA$124,800–$171,600 / yearYou will work on a cross-functional engineering team to get the most out of our vertically integrated manufacturing operation, and you will support and continually develop the engineering processes that turn a customer concept into a repeatable, qualified production program with consistent print quality, reliable equipment, and efficient throughput. Evaluate early-stage opportunities for feasibility, working with senior technical staff to define the new product introduction path and with program leads to set clear expectations and keep technical development on track.
Compliance Engineer SharkNinja IncCompliance EngineerNeedham, MA$72,700–$111,400 / yearRelevant discipline context: Biomedical/Bioengineering backgrounds are well-suited to ISO 10993 biocompatibility and clinical evaluation; Systems Engineering to ISO 14971 risk management and design controls; Chemical/Materials Engineering to material selection, substance compliance (REACH, RoHS), and biocompatibility testing; Computer Science/Software Engineering to IEC 62304 software lifecycle and embedded systems compliance. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains.
Senior Product Engineer, Additive - Aerospace & Defense VulcanFormsSenior Product Engineer, Additive - Aerospace & DefenseDevensAs a Senior Product Engineer, Additive at VulcanForms, you will design and direct the manufacturing processes within our aerospace & defense business unit that take customer designs and translate them into printable repeatable production processes. You will define the processes, procedures, work instructions, and systems that produce our components and sub-assemblies to customer specification, drawing on product design, fabrication, assembly, work-holding, cutting tools, and materials expertise.
Visiting Scientist Lahey Hospital and Medical CenterVisiting ScientistBoston, MA$155,002–$184,995 / yearThis position is ideal for a PhD scientist who enjoys hands-on technical development, close collaboration with clinicians, engineers, and industry partners, and contributing to NIH-funded, multi-center research programs, including active collaborations with Siemens Healthineers, with clear pathways toward clinical translation and impact. We are seeking a highly motivated Scientist with expertise in artificial intelligence (AI), machine learning, and magnetic resonance imaging (MRI) to support and advance cutting-edge translational research in cardiovascular imaging.
Product Engineer (Product Development) Intern Analog Devices IncProduct Engineer (Product Development) InternWilmington, MA$22–$41 / hourADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls.
Senior Process Engineer, Clinical Operations ElucidSenior Process Engineer, Clinical OperationsBoston, MARemoteWe are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Compensation will be influenced by a wide array of factors including but not limited to internal pay equity, job-related knowledge, skills, education, relevant experience, certifications, and geography as outlined in the job description.