Medical Device Compliance Engineer
Ninjakitchen
SharkNinja is seeking a Product Compliance Engineer in Needham, MA to drive regulatory approvals for consumer and medical device products. You will partner with global teams on certifications, risk management, and documentation from concept to mass production. The role requires 2–4 years of compliance experience, knowledge of FDA/EU regulatory pathways, and collaboration with testing labs to ensure market access. This position emphasizes ISO 13485 and software lifecycle standards. #J-18808-Ljbffr Ninjakitchen
- Senior Medical Device Compliance Engineer at SharkNinja in Needham, MA leads design controls and post-market compliance across SharkNinja’s Medical Devices portfolio. The role is hands-on and ensures medical device products are developed and maintained in compliance with...SuggestedOverseas
$87.8k - $150k
...for our consumers. If you believe the best way to do your job hasn’t been invented yet, you’ll fit right in. Senior Medical Device Compliance Engineer Needham, MA, United States The Senior Medical Device Compliance Engineer is responsible for medical device design control...SuggestedContract workTemporary workLocal areaOverseasFlexible hours$92.2k - $141.4k
...invented yet, you’ll fit right in.The Senior Product Safety & Compliance Engineer will have a direct partnership with our global product... ...mitigation solutions. This role includes active participation in medical device regulatory pathways alongside our consumer and commercial...SuggestedTemporary workLocal areaFlexible hoursShift work- ...experienced Senior Design Quality Engineer to support development of... ...electromechanical Class III medical systems. This role leads Design... ...to ensure regulatory compliance and robust product realization... ...Design Quality within medical devices (Class III preferred). ~ Strong...SuggestedFull time
- ...We are seeking a Contract System Test Engineer to support verification activities for a complex medical robotics system used in advanced robotic-assisted vascular... ...for complex electromechanical medical devices . The ideal candidate will contribute to quality...SuggestedFull timeContract work
- ...Takeda is seeking a Lead Engineer to oversee operations for medical devices, focusing on design, testing, and ensuring compliance with quality, safety, and performance standards. You will develop protocols, maintain GxP compliance, and lead activities like test method...
- ...Elevaris Medical Devices is seeking a Senior Quality Engineer to lead supplier quality programs and drive CAPA investigations in a medical device environment... ...CAPA processes, supplier qualification, regulatory compliance with ISO 13485, FDA QSR and EU MDR, plus risk...
- ...Australia - UK - South Africa - New Zealand - Ireland - Japan Job DescriptionLocation - Near Boston, MA, USAAutomation designControls engineering with focus on PLC and HMI programmingProcess Engineering with a focus on process developmentMold design - low cavitation and high...Work at office
- Advantage Technical seeks a Mechanical Engineer in Marlborough, MA for a hybrid contract role with remote onsite balance. You will support medical device development, design verification, and quality documentation within a fast-paced engineering environment. Responsibilities...Contract workRemote work
- IPG Photonics in Marlborough, MA is seeking a design engineering professional to lead development and validation of Class II electro-mechanical medical devices. You will design controls, support risk management, and collaborate with regulatory teams. This exempt role requires...
$82.3k - $220k
...solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our... ...and relevant education or training. Union ranges will be in compliance with the collective bargaining agreement's approved rates by...Full timeLocal area$72.7k - $111.4k
...hasn’t been invented yet, you’ll fit right in. The Product Compliance Engineer will partner with global product developers and... ...mitigation solutions. This role includes participation in medical device regulatory pathways alongside our consumer and commercial...Temporary workLocal areaFlexible hoursShift work$90k - $110k
...technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to... ...in external audits to ensure we maintain regulatory compliance. Assist with content review for Quality System documents and...Minimum wageOngoing contractFull timeH1bLocal areaRemote workWorldwideRelocation$140k - $165k
...rapidly growing, Boston-based medical technology company using AI to... ...a Senior Clinical Validation Engineer, you’ll be at the forefront of... ...clinical performance and regulatory compliance. Leveraging your expertise in SaMD validation, medical device regulation, and cardiovascular...Work at officeLocal areaRemote work- Pramand, LLC, based in Bedford, MA, is seeking a Quality Engineer II to support QA/QC for implantable medical devices. You will lead day-to-day quality activities, participate in design controls, and ensure compliance with cGMP, ISO 13485, and 21 CFR Part 820. You will...
$135k
...About the Role Entensiv is looking for a Senior Building Automation Service Engineer to join our growing team. This is a hands-on technical role for an experienced BAS professional who thrives on solving complex system challenges, building strong client relationships,...Full timeWork at officeFlexible hours$76.5k - $110k
...job hasn’t been invented yet, you’ll fit right in. Mechanical Engineer II — Outdoor Heated SharkNinja | Needham, MA | On-Site 4+ Days... ...this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, flexible spending...Temporary workLocal areaFlexible hours$63.8k - $95k
...started as a sketch on someone's desk here. We're hiring Mechanical Engineers to take the next generation of Shark and Ninja products from... ...this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, flexible...Temporary workLocal areaFlexible hours$63.8k - $95k
...job hasn't been invented yet, you'll fit right in. Mechanical Engineer I - Indoor Heated Needham, MA - Global Headquarters | Product Development... ...successful candidate. Pay Range $63,800 - $95,000 USD Benefits medical insurance dental insurance vision insurance flexible spending...Temporary workFlexible hours$84.93k - $116.78k
...Corning's fiber optic cable manufacturing team is seeking a Process Engineer to design, implement, and optimize manufacturing processes that... ...of service. Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support,...Full timeWork at officeMonday to FridayShift work- Clinical Engineers are focused on bridging clinical needs with product and process development. They work closely with clinicians and surgeons to gather clinical input, understand current challenges, and conduct Voice of Customer (VOC) activities to ensure solutions align...
$141.8k - $212.8k
...AMP) Team is seeking a Principal Process Engineer to develop cutting-edge manufacturing... ...manufacturing sustainability.Documentation and Compliance Excellence: Author, review, and approve... ...their growth and aspirations. From medical, dental and vision benefits to generous...Full timeSummer workFlexible hours- ...offered opportunity to grow. Join us!The Automation Controls Engineer will design, program, install, modify, and repair all aspects... ...for this position is contingent on the candidate having export compliance eligibility for access to U.S. controlled technology which comes...Permanent employmentLocal area
- ...The Role The Field Clinical Engineer serves as a key technical and... ...and data analysis to monitor device performance, troubleshoot technical... ..., and study execution in compliance with study protocols,... ...relevant engineering, clinical, or medical device experience preferred....Remote work
$142k - $227k
Job TitleSr. Product Support Engineer (Medical Devices)Job DescriptionYour role:Leads the end-to-end design, implementation, and deployment of complex infrastructure solutions, ensuring technical architectures align with client requirements, business objectives, and industry...Full timeWork at officeImmediate startWork visaRelocation package3 days per week- BioSpace is seeking a design-focused engineer to execute Design for Robustness methodologies across mechanical design projects for drug delivery devices. You will provide technical recommendations to reduce variation and work with manufacturing and quality teams to ensure...
- 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. The ideal candidate... ...include test method development and ensuring compliance with FDA regulations. Strong communication skills...
- ...could help make great things possible not only in your community, but around the world. HDR is seeking a Senior Mechanical/Process Engineer to support our growing portfolio of liquified natural gas (LNG), industrial gas, and hydrocarbon infrastructure projects across...For contractorsWork at office
- ...Job Description Job Description Location: Somerville, MA Senior Mechanical Engineer – Medical Device Overview: Micro-Leads is a fast-paced early-stage company developing an injectable medical device to treat people with chronic pain with greater efficacy....Contract work
- ...Compliance Engineer, Product Safety & EMC Location Marlborough, MA About the Job As a Compliance Engineer focused on Product Safety and Electromagnetic Compatibility (EMC), you will play a key role in ensuring that our scientific and industrial products...Work at office
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