Senior Medical Device Compliance & Quality Engineer
SharkNinja
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 global regulatory requirements within a fast-paced consumer electronics environment. You will collaborate with Engineering, Product Development, Legal, Program Management, and Quality Engineering, including overseas #J-18808-Ljbffr SharkNinja
- SharkNinja in Needham, MA is seeking a Senior Medical Device Compliance Engineer to own design controls and post-market sustaining activities across its... ...collaborating with Engineering, Legal, Program Management, Quality, and overseas manufacturers to deliver safe, compliant...QualitySeniorMedical deviceOverseas
$92.2k - $141.4k
...invented yet, you’ll fit right in.The Senior Product Safety & Compliance Engineer will have a direct partnership... ...includes active participation in medical device regulatory pathways alongside our... ...for Medical DevicesISO 13485 - Quality Management SystemsIEC 62366-1 - Usability...QualitySeniorMedical deviceTemporary workLocal areaFlexible hoursShift work$87.8k - $150k
...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... ...Engineering, Product Development,Legal,ProgramManagement, and Quality Engineering, including overseas manufacturing partners....QualitySeniorMedical deviceContract workTemporary workLocal areaOverseasFlexible hours- ...how it will be done. Job Summary: As the Senior Quality, Compliance, and Regulatory Engineer at CAI, you will serve as both a strategic leader... ...experience in sterile manufacturing, biotechnology, medical device, and/or Cell and Gene is highly advantageous....QualitySeniorMedical deviceLocal areaWorldwide
$72.7k - $111.4k
...yet, you’ll fit right in. The Product Compliance Engineer will partner with global product... ...This role includes participation in medical device regulatory pathways alongside our consumer... ...for Medical Devices ISO 13485 - Quality Management Systems IEC 62366-1 - Usability...QualityMedical deviceTemporary workLocal areaFlexible hoursShift work$100k - $120k
...Senior Quality Engineer – Greater Billerica, MA Growing manufacturer of advanced products serving the medical device, defense and semiconductor industries seeks an experienced Senior Quality Engineer to own product quality in an assembly-based environment where quality...QualitySeniorMedical device$140k - $165k
...growing, Boston-based medical technology company... ...outcomes, improved quality of care, and reduced... ...attacks and strokes!As a Senior Clinical Validation Engineer, you’ll be at the... ...and regulatory compliance. Leveraging your expertise... ...validation, medical device regulation, and...QualitySeniorMedical deviceWork at officeLocal areaRemote work- Spectra Medical Devices, LLC in Wilmington, MA seeks a Senior Quality Engineer to lead supplier quality, CAPA, and regulatory compliance programs in a medical device setting. The role focuses on investigations, audits, risk management, and continuous improvement across...QualitySeniorMedical device
- BioSpace is seeking a design-focused engineer to execute Design for Robustness methodologies... ...design projects for drug delivery devices. You will provide technical recommendations... ...variation and work with manufacturing and quality teams to ensure system robustness. The...QualitySeniorMedical device
- ...cutting edge solutions to tough problems.Job SummaryProvide quality engineering support to ensure the quality of design, sourcing and... ...Engineering or ScienceAt least 4 years’ experience in OEM medical device manufacturing of FDA approved or 510k cleared productAble...QualitySeniorMedical deviceFor subcontractorWork at office
- ...IPG Medical Corporation Job OpportunityIPG Medical Corporation is focused on developing... ...is to develop innovative medical device laser solutions that make the world a... ...to verify performanceCollaborate with Quality and Engineering to troubleshoot issues, implement rework...QualitySeniorMedical device
- AstraZeneca is seeking an Engineer III in the Alexion Device Development organization to lead human factors and usability engineering across pipeline... ...with multiple teams to ensure HF activities comply with quality and regulatory requirements. The role requires...QualitySeniorMedical deviceWork at office
- Hologic, Inc. in Marlborough, MA is seeking a Senior Product Development Engineer to lead new product development from concept to production, applying... ..., Marketing, PMQA, Manufacturing Engineering, and Quality Engineering, and contribute to risk management, design verification...QualitySeniorMedical device
- What You’ll DoThe Senior Quality Assurance Specialist provides quality... ...chain activities, ensuring compliance with global regulatory... ..., Pharmaceutical Sciences, Engineering, or a related scientific discipline... ...of pharmaceutical and medical device Quality Management Systems....QualitySeniorMedical deviceFull timeContract workImmediate start
$150k - $195k
...and daily lives.WHOOP is seeking a Senior Reliability Engineer to lead the charge in ensuring our hardware... ...while maintaining industry-leading quality and performance standards.... ...volume consumer electronics or wearable/medical device environmentsBachelor's or Master’s degree...QualitySeniorMedical deviceFull timeWork at officeRelocation$155k - $185k
...lives.We are looking for a Senior Program Manager, SaMD... ...of our Software as a Medical Device programs. This role will... ...Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver against... ...development in compliance with design controls and...QualitySeniorMedical deviceFull timeWork at officeRelocation$90k - $165k
...Sr. Verification Engineer A Verification Engineer is a technical position responsible... ...and verification of software as a medical device, medical device systems and software embedded... ...within schedule constraints, meeting quality standards and goals. Role Responsibilities...QualitySeniorMedical device$160k - $190k
...organization in healthcare is seeking a Patent Agent to provide high-quality intellectual property services. The role involves managing... .... Candidates must hold a bachelor's degree in science or engineering with at least five years of relevant experience in a law firm....QualitySeniorMedical device- Werfen seeks a Senior Engineering Group Lead to act as technical authority for coagulation programs and to own design controls, product reliability... ..., while partnering with Mechanical, Electrical, Software, Quality, Regulatory, and PM groups. #J-18808-Ljbffr Socket.devQualitySeniorMedical device
- ...in Boston is seeking an Operational Area Quality Senior Manager to lead quality oversight for assembly manufacturing of medical devices and combination products. You will review... ...internal teams. The role focuses on GMP compliance, risk management, and design control alignment...QualitySeniorMedical device
- Werfen is seeking a Senior Engineering Group Lead in Bedford, MA to serve as a player-coach for Class... .... The role requires FDA-regulated device experience, a strong leadership presence... ...across mechanical, electrical, software, quality, regulatory, and project management...QualitySeniorMedical device
- What You’ll DoThe Senior Quality Engineer is responsible for supporting the effective establishment... ...factors/usability engineering of medical devices, as well as driving continuous improvement... ...quality management system to ensure compliance with regulatory requirements. This...QualitySeniorMedical deviceFull timeWork at officeImmediate start
- ...Senior Manufacturing Engineer Medical DeviceThe Senior Manufacturing Engineer plays a key role in bridging... ...manufacturing for medical devices, ensuring robust and scalable manufacturing... ...The role emphasizes efficiency, quality, regulatory compliance, and cost-effectiveness while...QualitySeniorMedical deviceContract workWork at office
- LAB Medical, a ISO 13485 registered manufacturer, is seeking a Buyer/Senior Buyer in Massachusetts to lead raw material procurement... ...to support production and quality goals. You will collaborate cross... ...-functionally, ensure ISO compliance, and oversee annual inventory...QualitySeniorMedical device
- Werfen seeks a Senior Engineering Group Lead to own design controls and product reliability for Class II/III coagulation programs. You will... ...validation docs, and work with Mechanical, Electrical, Software, Quality, Regulatory, and PM teams while mentoring a five-member team...QualitySeniorMedical device
- Senior Mechanical Engineer - Permanent - Boston, USLead the development of cutting-edge medical device platforms that transform blood management and patient... ...experience supporting compliance activities.Hands-on... ...on materials selection, quality specifications, troubleshooting...QualitySeniorMedical devicePermanent employment
- Vertex Pharmaceuticals seeks an Operational Area Quality Senior Manager to provide quality leadership for assembly manufacturing of medical devices and combination products. You will oversee MBRs/EBRs/DHRs, CAPAs, deviations, investigations, change controls, and supplier...QualitySeniorMedical device
$120k - $140k
Company DescriptionBoston Engineering is where innovative ideas become real-... ...robotics and autonomous systems to medical devices, digital solutions, defense... ...product development effortsEnsure compliance with Boston Engineering's Quality Management System and engineering...QualitySeniorMedical devicePermanent employmentFull timeWork at officeRelocation package- Hologic, Inc. is seeking a Senior Manager, Regulatory Operations to lead strategic and... ...scalable processes while supporting a growing medical device portfolio. The incumbent directs the regulatory team, collaborates with R&D, Quality, Clinical and Manufacturing, and...QualitySeniorMedical device
- ...located in Burlington, Massachusetts, is seeking an experienced Quality Engineering lead to oversee the design phase activities for their... ...successful candidate will manage risk assessment and ensure compliance with regulatory standards. With a minimum of 10 years in quality...QualitySeniorMedical device
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