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
$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...SuggestedFull timeContract workTemporary workLocal areaOverseasFlexible hours- 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
- SharkNinja in Needham, MA is seeking a Senior Medical Device Compliance Engineer to own design controls and post-market sustaining activities across its Medical Devices portfolio. You will ensure global regulatory compliance, lead DHF reviews, risk management, and ECN...SuggestedOverseas
- SharkNinja is seeking a Senior Medical Device Compliance Engineer in Needham, MA to lead design controls and post‑market compliance across medical devices. This hands‑on role collaborates with Engineering, Legal, Program Management and Quality to ensure safe, compliant...SuggestedOverseas
$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...Full 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...Full timeContract work
- ...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
- 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...
- Amgen is seeking a Sr. Engineer in Device Engineering at our Massachusetts site to support device development and robustness. You will ensure robust execution of Design for Robustness disciplines across projects, interfacing with SMEs and cross-functional teams to optimize...Flexible hours
$160k - $180k
...lead testing activities in the field of medical diagnostics. You will oversee full... ...and ensure high standards of quality in compliance with applicable regulations. The ideal... ...experience and a Bachelor's degree in Engineering or Science. This position offers competitive...- Jobtailor is seeking a Systems Engineer to drive system-level design and regulatory compliance for medical devices. You will work with electrical, software, mechanical, manufacturing, and quality engineers to ensure safe, effective products. Responsibilities include risk...
- ...Bedford, MA is seeking a Lead Test Engineer to manage testing activities... ...develop test frameworks for medical diagnostic systems. Ideal... ...particularly in in vitro medical devices. Responsibilities include... ...maintaining traceability, and ensuring compliance with medical device standards...
- Werfen in Bedford, MA seeks a Senior Systems Engineering Group Leader to oversee technology application across multiple programs, ensure common system architecture for Class II and III medical devices, and serve as technical authority and people leader. You will drive requirements...
- Werfen is seeking a Senior Systems Engineering Group Leader in the Bedford area to drive design inputs/outputs for Class II/III medical devices, oversee V&V, and manage cross-functional teams. The role focuses on risk management, requirements traceability, and system architecture...
- ...company is looking for a Design Assurance Engineer to join their team in Marlborough, MA.... ...development and sustaining of advanced medical device products, with a focus on design... ...verification and validation, regulatory compliance, and electro-mechanical medical device...Full time
- ...Inc. seeks a Lead Product Development Engineer to drive design, verification, validation... ..., and commercialization of innovative medical devices from concept through launch. You will lead... ...solutions, and ensure regulatory compliance, manufacturability, and scalable transfer...
$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- ...required; Selenium required Title : Quality Assurance Automation Engineer Location: Wellesley, MA; hybrid 3 days/week; open to... ...suites and analyze results to identify defects and ensure compliance with quality standards. Continuous Integration &...3 days per week
$63.8k - $95k
...hasn’t been invented yet, you’ll fit right in. Mechanical Engineer I - Indoor Heated Needham, MA — Global Headquarters | Product... ...this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, flexible...Full timeTemporary workLocal areaFlexible hours$110.39k - $151.81k
About Analog DevicesAnalog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader... ...on LinkedIn and Twitter (X).Hardware Engineer - Medical DevicesWe are seeking a hands-on... ...concept through production, ensuring compliance with medical standards and regulatory...Permanent employmentFull timeWork at officeFlexible hoursDay shift- 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- Boston Scientific seeks a Supplier Quality Engineer III in Marlborough, MA, with hybrid work arrangements (onsite 3 days, optional 2 remote... ...will support SFMD products in Endoscopy, focus on Single-Use Devices and Capital Equipment, and collaborate with global teams to...Remote work
- IPG Photonics is seeking a Post Market Surveillance Quality Engineer to monitor the performance, safety, and quality of IPG Medical devices after launch. You will lead investigations, analyze complaints, and support regulatory reporting across global markets. You will collaborate...
$134.64k - $201.97k
About Analog DevicesAnalog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader... ...LinkedIn and X.Product Cybersecurity Engineer - Medical DevicesThe Health Solutions Business... ...the security, privacy, and regulatory compliance of connected medical devices and Software...Permanent employmentFull timeWork at officeDay shift- Initial Therapeutics, Inc. is seeking a Device Engineering Sr. Engineer in Cambridge, Massachusetts. This role involves supporting device development and engineering robustness within the Device Engineering group. The right candidate will work on optimizing drug delivery...Flexible hours
- ...hearing protection, communication, noise reduction, and ultrasound devices and systems for a wide variety of military and commercial... ...acoustics and signal processing in the undersea warfare domain. This engineer will lead and contribute to a multi-disciplinary team working...For contractors
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Medical Device Compliance Engineer. Be the first to apply!
- medical device Needham Heights, MA
- director quality assurance regulatory affairs Needham Heights, MA
- compliance lead Needham Heights, MA
- medical compliance Needham Heights, MA
- compliance team leader Needham Heights, MA
- compliance Needham Heights, MA
- regulatory affairs assistant Needham Heights, MA
- health compliance Needham Heights, MA
- vice president regulatory affairs Needham Heights, MA
- housing compliance Needham Heights, MA



