Senior Manager, Software Device Quality & Compliance
Takeda
Takeda is seeking a Senior Manager for Software Device Quality in Lexington, MA. This role is pivotal in overseeing quality for software medical devices and combination products throughout their lifecycle, ensuring compliance with regulatory requirements. The ideal candidate will have over 7 years of experience in Quality Assurance within the medical device sector, strong regulatory knowledge, and a proven ability to lead cross-functional teams effectively. Benefits include a competitive salary, comprehensive healthcare, and generous vacation policies. #J-18808-Ljbffr
- ...Takeda Pharmaceuticals International GmbH is seeking a Senior Manager, Software Device Quality to lead quality and technical processes for software... ...medical devices. The successful candidate will ensure compliance with regulatory standards, collaborate with product development...Senior
$137k - $215.27k
...knowledge. Job Description About the role The Senior Manager, Software Device Quality is a seasoned quality and technical leader responsible... ..., and post-market support. This role ensures compliance with all applicable quality and regulatory requirements...SeniorMinimum wageFull timeTemporary workLocal area- ...specializing in hardware development for EEG devices. You will contribute to creating state-of-the-art medical technology by ensuring product quality and regulatory compliance through comprehensive requirements management and systems engineering. The ideal candidate has...Senior
- A medical device company is seeking a Senior Manufacturing Engineer to enhance manufacturing processes... ...driving process improvements, ensuring quality compliance, and monitoring equipment... ...analysis tools and strong project management skills. This is an on-site role located...Senior
$115k - $182k
...Philips International in Bedford, MA is looking for a Hardware Project Manager in the Medical Device sector. The role entails overseeing and coordinating multiple hardware project workstreams within the Philips Image Guided Therapy Devices business. The right candidate...SeniorFull time- ...MassMEDIC is seeking a Senior Systems Engineer to advance innovative processes in medical devices. This role involves translating user needs into requirements, defining system architecture, and ensuring product compliance. The ideal candidate will have a Bachelor's degree...Senior
- ...A technology firm in Waltham, MA is seeking a Senior Software Engineer specializing in cybersecurity for embedded medical devices. This role involves working directly with clients to design and implement secure solutions, while also leading technical execution and supporting...Senior
$109k - $183k
...Medical Care (Schweiz) AG is seeking a Principal RA Associate Devices in Waltham, MA. The ideal candidate will develop regulatory strategies... ...necessary FDA submissions, and oversee day-to-day project management. With a minimum of 8 years of experience in regulatory...Senior$90k - $120k
We are seeking an Engineer III to support systems engineering programs related to software within a medical device environment. This individual will execute technical workstreams, partnering with various teams to troubleshoot complex issues. The successful candidate will...Senior$160k - $190k
...highly experienced engineering leader to oversee technology management across multiple programs. The ideal candidate must have... ..., utilizing project management skills, and ensuring compliance with medical device regulations. The position offers a competitive salary range...Senior$160k - $190k
Werfenlife SA. seeks an experienced Engineering Manager in Bedford, Massachusetts, to lead... ...management across projects in medical devices. The ideal candidate will have over 15 years... ...technical decision-making, and ensuring compliance with industry standards. Competitive...Senior- ...Anika is looking for a Senior Process Engineer to lead process improvement initiatives in medical device manufacturing. This role requires the design, validation, and implementation... ...will focus on optimizing processes, project management, and collaborating with multidisciplinary...Senior
- Activ in Boston, MA is looking for a Senior Sustaining Engineer to lead manufacturing and engineering efforts. You will serve as... ...with our contract manufacturer while ensuring product quality and compliance. The ideal candidate will have 6-10+ years of relevant experience...SeniorContract work
- A leading medical device firm in the U.S. is seeking a Mechanical Engineer with over 6 years of experience in mechanical design and development... ...Responsibilities include test method development and ensuring compliance with FDA regulations. Strong communication skills and...Senior
$131.25k
...justice issues with our ecosystem of devices and cloud software. Like our products, we work better together... .... Your Impact As a Software Product Manager at Axon, you will lead the definition... ..., and customer teams to deliver high-quality, user-centered solutions that solve...SeniorTemporary workWork at officeRemote workShift work$71.3k - $124.5k
...Mass Digital Health is seeking a Senior Project & Program Manager to guide projects through the customer onboarding and post-sales lifecycle effectively. The role offers a hybrid work model where you will spend eight days a month onsite within 50 miles of your residence...SeniorRemote work$200k - $220k
Software Architect Salary Range: $200,000 - $220,000 + full benefits... ...) Industry: Medical Device Diagnostics Must-Have Core Skills... ...Summary Reporting to the Software Manager for Architecture and... ...Functional Leads. Technical Quality: Conduct rigorous code/design...$71.3k - $124.5k
...Senior Project & Program Manager (Sales Lifecycle - Software) Responsible for guiding assigned projects through the customer onboarding and post‑sales lifecycle... ...ensure projects advance efficiently and deliver high‑quality solutions and services while maintaining customer...SeniorWork at officeRemote work- ...Principal Mechanical Engineer in Burlington, Massachusetts, to lead the design and development of complex Class III implantable medical devices. This highly visible role demands extensive experience in regulated medical device environments and strong proficiency in...
$165k - $200k
...collaborate with engineering teams. Candidates must have at least 12 years of product development experience, preferably in in vitro medical devices. This role offers a competitive salary range of $165,000 to $200,000 and various benefits including medical, dental, vision...Senior$146k - $194k
...ABOUT THE TEAM Our Quality Engineering team... ...JOB We are hiring a Senior Manufacturing... ...expertise in quality management systems and statistical... ...Management System compliance and sustainability... ...complex hardware/software systems. 5+ years... ..., or medical device sectors. Experience...SeniorFull timeRelocation- ..., Massachusetts, is seeking a Staff/Principal Mechanical Engineer to lead the design and development of advanced Class III medical devices. In this highly visible role, you will collaborate with cross-functional teams and drive technical problem solving throughout the product...
$170k - $210k
...’re setting new standards in quality and reliability. Nova Biomedical... ...com About the role The Software Quality Assurance Senior Manager leads the software quality... ...reliability, and regulatory compliance of software used in medical device systems. This role oversees verification...SeniorHourly payWork at officeFlexible hours$172.5k - $260.1k
...ensure you are not duplicating efforts. Job Category Software Engineering Job Details About Salesforce Salesforce... ...Technology (DET) is looking for a strategic and result-driven Senior Manager to lead the vision, development, and ongoing success of our externally...SeniorContract workLocal area$142k - $227k
...Job Title Software Project Manager – Medical Device (Bedford, MA) Job Description Software Project Manager – Medical... ...risk‑taking with escalation to senior management when necessary. You will... ...functionally with product development, quality, operations, field service, and...Work at officeWork visaRelocation package- ...Device Integration Engineer (Non-Clinical) Woburn, MA - Occasional travel required... ...and adhering to the BILH IT system change management processes Work with the user... ...internally in IS or with a vendor. Delivers high quality support during the implementation of new...Local areaHome office
- Mass Digital Health is seeking a Senior Software Architect to provide architectural ownership and functional leadership within... ...software architecture for assigned platforms and ensuring compliance with medical device regulations. The ideal candidate will have over 8 years...Senior
$157k - $249k
...Senior Softw are Architect - Integration... ...We are seeking a Software Architect to provide... ...Guided Therapy Devices (IGT-D) team, you... ...teams to deliver high-quality, compliant, and... ...practices. Ensure compliance with medical... ...resources, product management, quality, regulatory...SeniorFull timeTemporary workWork at officeLocal areaWork visaRelocation package3 days per week- CyberCoders is looking for a skilled Software Architect to join their team in Burlington, MA. The ideal candidate will have extensive medical device software experience and strong proficiency in languages such as C++, Java, Angular, or Python. In this role, you will be...Senior
$130k
...Senior Technology & Systems Consultant (Massachusetts - Client Sites) We're a leading IT Consulting, Managed Services and Cloud Computing Company, providing innovative services... ...Microsoft Entra ID Purview Compliance and device management. In-depth knowledge...Senior
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