Principal Combination Product Quality Engineer
4 weeks ago
This is a hybrid role that requires a strong understanding of quality assurance principles and practices in the development and manufacturing of combination products.
Key Responsibilities:- Lead quality oversight and provide QA strategy for combination product design and development programs.
- Provide technical quality support for design-related continuous improvement efforts, design changes, and market expansions.
- Provide quality oversight for device constituent and component suppliers used in combination products.
- Provide combination product quality support for regulatory intelligence processes.
- Lead/support efforts to enhance knowledge of combination product requirements throughout the Quality organization.
- Bachelor's degree in engineering or sciences.
- 10 years of device and/or combination product cGMP experience.
- Experience of first-hand GMP management is preferred.
- Understanding of global Device and Combination Product regulations, standards, and guidelines.
- Working knowledge of Pre-filled Syringe and Autoinjector technical standards is preferred.
Alnylam is a leading biopharmaceutical company that is committed to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential.
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Principal Combination Product Quality Engineer
4 weeks ago
Cambridge, Massachusetts, United States Alnylam Full timeJob Title: Principal Combination Product Quality EngineerThis role is considered a hybrid position, combining technical and leadership responsibilities.Job Summary:The Principal Combination Product Quality Engineer will provide quality assurance support to Combination Product Design and Development, Design Transfer, and on-market support. This role will work...
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Cambridge, Massachusetts, United States Alnylam Full timeThe Principal Combination Product Quality Assurance Specialist will provide QA support to Combination Product Design and Development, Design Transfer, and on-market support.This role will work cooperatively with their counterparts throughout Technical Operations and Quality to ensure safe and effective combination products are developed, brought to market,...
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Cambridge, Massachusetts, United States Scholar Rock Full timeAbout Scholar RockScholar Rock is a pioneering biopharmaceutical company dedicated to discovering, developing, and delivering innovative life-changing therapies for individuals suffering from serious diseases with high unmet needs. Leveraging its expertise in the biology of the transforming growth factor beta (TGF?) superfamily, the company is committed to...
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Cambridge, Massachusetts, United States Scholar Rock Full timeAbout Scholar RockScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins, the company is focused on advancing innovative treatments where...
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Principal Backend Software Engineer
3 weeks ago
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Principal Backend Software Engineer
3 weeks ago
Cambridge, Massachusetts, United States Context Labs Full timeJob Title: Principal Backend Software EngineerAbout the Role:We are seeking a highly skilled Principal Backend Software Engineer to join our team at Context Labs. As a key member of our engineering team, you will be responsible for designing, developing, and maintaining our blockchain services and APIs.Key Responsibilities:Lead the development of our...
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Principal Concept Development Engineer
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Cambridge, Massachusetts, United States Boston Scientific Full timeAbout the Role:Boston Scientific is a global medical technology leader with a mission to transform lives through innovative medical solutions that improve the quality of patient care. We are seeking a highly skilled Principal Concept Development Engineer to join our Electrophysiology Division in Waltham, MA. Key Responsibilities:Design and develop novel...
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Regulatory Advisor for Drug-Device Combinations
4 weeks ago
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Principal Product Manager
3 weeks ago
Cambridge, Massachusetts, United States Moderna Full timeAbout the RoleModerna is seeking an experienced Principal Product Manager to lead the development of our mRNA technology platform. As a key member of our product team, you will be responsible for defining and delivering on our product roadmap, working closely with cross-functional teams to bring innovative solutions to market. Key ResponsibilitiesPartner...
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Principal Product Manager
3 weeks ago
Cambridge, Massachusetts, United States Moderna Full timeAbout the RoleModerna is seeking an experienced Principal Product Manager to lead the development of our mRNA technology platform. As a key member of our team, you will be responsible for defining and delivering product strategies that drive business growth and customer satisfaction.Key ResponsibilitiesPartner with cross-functional teams to develop and...
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Principal Software Test Engineer
4 weeks ago
Cambridge, Massachusetts, United States Boston Scientific Full timeAbout This Role:The Principal Software Test Engineer will be part of a highly effective product quality team, working closely with developers in an Agile environment. This role will provide technical guidelines to product test teams, working globally with managers, test leads, and engineers to develop test cases for a wide range of software components,...
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Principal Software Test Engineer
3 weeks ago
Cambridge, Massachusetts, United States Boston Scientific Full timeAbout This Role:The Principal Software Test Engineer will join a highly effective product quality team, working side-by-side with developers in an Agile environment, providing technical guidelines to product test teams, working closely with managers, test leads, and engineers globally by developing test cases for a wide range of software components,...
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Principal Software Test Engineer
4 weeks ago
Cambridge, Massachusetts, United States Boston Scientific Full timeAbout This Role:The Principal Software Test Engineer will join a highly effective product quality team, working side-by-side with developers in an Agile environment, providing technical guidelines to product test teams, working closely with managers, test leads, and engineers globally by developing test cases for a wide range of software components,...
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Principal CMP Engineer
3 weeks ago
Cambridge, Massachusetts, United States Draper Labs Full timeJob Description:Draper Labs is seeking a highly skilled Principal CMP Engineer to join our team at the Draper microfabrication facility. As a key member of our multidisciplinary team, you will be responsible for advancing our in-house CMP capability and applying it to wafer-level packaging techniques for advanced integration of sensor...
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Principal FPGA Design Engineer
4 weeks ago
Cambridge, Massachusetts, United States Draper Labs Full timeJob Title: Principal FPGA Design EngineerDraper Labs is seeking a highly skilled Principal FPGA Design Engineer to join our digital design team. As a key member of our team, you will be responsible for designing and developing complex FPGA architectures, working closely with cross-functional teams to translate project and system requirements into...
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Principal Communications Engineer
3 weeks ago
Cambridge, Massachusetts, United States Draper Labs Full timeJob Description:A highly skilled Principal Communications Engineer is needed to design, develop, test, and oversee the manufacturing of electrical printed circuit boards (PCBs), analog and digital circuits, electronic equipment, sensors, motors, radar, and navigation systems.The engineer will develop the architecture, design circuits, perform simulations,...
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Principal Backend Software Engineer
3 weeks ago
Cambridge, Massachusetts, United States Context Labs Full timeJob SummaryContext Labs is seeking a highly skilled Principal Backend Engineer to drive forward our product initiatives with the ImmutablyTM Platform and analytics spaces.This role will lead the development of our blockchain services, APIs, and related product capabilities, as well as provide thought leadership, upskilling of less senior engineers, and...
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Principal Communications Engineer
3 weeks ago
Cambridge, Massachusetts, United States Draper Labs Full timeJob Summary:A Principal Communications Engineer at Draper Labs designs, develops, tests, and oversees the manufacturing of electrical printed circuit boards (PCBs), analog and digital circuits, electronic equipment, sensors, motors, radar, and navigation systems. The engineer develops the architecture, designs circuits, performs simulations, performs...
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Senior Principal Supplier Quality Specialist
4 weeks ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob Title: Senior Principal Supplier Quality SpecialistAkebia Therapeutics is seeking a highly skilled and experienced Senior Principal Supplier Quality Specialist to join our Quality Assurance team. This role will be responsible for managing and overseeing Akebia's suppliers and contract manufacturing organizations (CMOs) to ensure compliance with industry...
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Principal Systems Engineer
4 weeks ago
Cambridge, Massachusetts, United States Draper Labs Full timeJob Summary:Draper Labs is seeking a highly motivated and experienced Principal Systems Engineer to join our team. As a key member of our Space and Mission Critical Systems group, you will be responsible for performing key systems engineering tasks in a model-based environment (MBSE), using formal development and verification processes in support of Draper's...