Senior Device Quality Lead - Medical Devices & Risk Mgmt
Biogen
Biogen, Inc. is seeking a Senior Device Quality Engineering Lead to oversee quality for medical devices. This hybrid role requires strong leadership in quality oversight during the design and lifecycle management phases. The successful candidate will have extensive experience in regulatory compliance, design control, and risk management, making an impact on product quality across the organization. Join us to help deliver life-changing medicines while enjoying a collaborative and dynamic work environment. #J-18808-Ljbffr
Vacancy posted 12 hours ago
Similar jobs that could be interesting for youBased on the Senior Device Quality Lead - Medical Devices & Risk Mgmt in Cambridge, MA vacancy
$90 - $130 per hour
...Job Title Project Manager (Medical Devices III) Position Type Contract Location... ..., Regulatory Affairs, Quality, Manufacturing, and external... ...timelines. Responsibilities Lead integrated project plans focused... ...Design Controls (21 CFR 820), risk management (ISO 14971), and applicable...QualitySeniorRiskMedical deviceContract workIpro Networks Pte. Ltd.
Cambridge, MA4 days ago$212k - $333.19k
...patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device... ...regulatory filings are of high quality and right first time... ...Reviews and approves medical device development design... ...device-related regulatory risks, ensuring timely...QualitySeniorRiskMedical deviceMinimum wageTemporary workLocal areaRemote workWorldwideNight shift$43.92 - $68.62 per hour
...Capgemini is seeking a Senior Design Quality Engineer in Boston to ensure end-to-end design quality for Class II/III medical devices. You will oversee design controls and compliance throughout... ...the product lifecycle, driving risk management and software quality assurance...QualitySeniorRiskMedical deviceHourly payRemote workCapgemini
Boston, MA4 days ago$90k - $130k
Sanofi is seeking a Device Quality Engineer to enhance patient safety and ensure compliance... ..., MA. The ideal candidate will lead the Device Risk Management processes and collaborate... ...requires substantial experience in the medical device industry along with a relevant...QualityRiskMedical device- ...Location: Somerville, MA Senior Mechanical Engineer – Medical Device Overview: Micro-Leads is a fast-paced early-stage company... ...-ops) Adhere to Micro-Leads quality management system, understands... ...design inputs/outputs, risk management, verification and validation...QualitySeniorRiskMedical deviceContract work
Micro Leads Inc
Somerville, MA19 days ago $88.6k - $246.6k
...Solution Implementation Lead is the end-to-end execution... ...operationalization of new connected medical device and digital health solutions.... ...milestones, dependencies, risks, constraints, and mitigation... ...Solution - Level Readiness, Quality & Compliance...QualityRiskMedical deviceFull timePart timeImmediate startWorldwideIQVIA
Boston, MA7 days ago$126.6k - $189.8k
...Development Engineering Senior Scientist focuses on... ...Research and Development, Device Quality Control, Device... ...device products.* Author Risk Analyses, including DFMEA... ...and externally.* Leads Design Reviews to completion... ...experience with Medical Device and Combination...QualitySeniorRiskMedical deviceSummer workFlexible hours- ...Development Engineer within the Alexion Device Development organization. The... ...teams, including Device Quality, Regulatory Affairs, Clinical,... .../development engineer in the medical device or pharmaceutical... ...medical device product development risk management methodologies....QualitySeniorRiskMedical deviceWork at office
$138k - $185k
## Senior Device Quality Engineering LeadApplyremote type: Hybridlocations: Cambridge... ...Device Quality Engineering Lead, you will hold a pivotal role... ...of design control and risk management activities for combination products and medical devices. This senior-level position...QualitySeniorRiskMedical deviceTemporary workLocal area$133.5k - $192.83k
## Device - Senior Quality Engineer, Invitro DiagnosticsBewerbenlocations: Cambridge... ..., Post-Markey Surveillance, risk management (ISO14971),... ...with CLIA, CAP, and ISO 15189. Lead quality oversight for IVD... ...management systems for IVD medical devices is preferred* Strong...QualitySeniorRiskMedical deviceWorldwide$115.49k - $156.26k
Device Engineering Senior Engineer What you will do: In this vital role you will... ...disciplines to identify risks and mitigations, opportunities... ...with manufacturing, quality, and suppliers to improve product... ...years of experience developing medical devices, ideally Class II...QualitySeniorRiskMedical device$150k - $165k
...developed at MIT, Harvard Medical School and by the... ....) It is the only device that, sensing a... ..., increase their quality of life, reduce... ...been referred by leading-edge rehabilitation... ...alignment, execution, risk management, and... ...to senior leadership and stakeholders...QualitySeniorRiskMedical deviceFull time- ...position will serve the role of medical device development engineer within... ...mechanical design, testing, risk management activities, technical... ...Effects Analysis (UFMEA) Lead design verification and validation... ...testing. Collaborate with Quality, Regulatory, Human Factors,...QualitySeniorRiskMedical device
- ...Delve Inc. is seeking a Systems Engineer to lead product development in the medical device industry. This role involves guiding cross-functional teams, managing technical risks, and translating user needs into systems frameworks. The ideal candidate will have a Bachelor...SeniorRiskMedical device
Delve
Boston, MA3 days ago - ...A leading biomedical company in Waltham is seeking a Senior Manager for Software Quality Assurance to oversee software compliance in medical devices. The role demands at least 10 years of experience in QA and leadership within regulated industries. Key responsibilities...QualitySeniorMedical deviceFlexible hours
Nova Biomedical
Waltham, MA4 days ago $115.49k - $156.26k
...transforming your career. Device Engineering Sr.... ...Robustness Disciplines Lead. Responsibilities:... ...disciplines to identify risks and mitigations, opportunities... ...with manufacturing, quality, and suppliers to... ...within development of Medical Devices, ideally Class...QualitySeniorRiskMedical deviceFlexible hoursAmgen
Cambridge, MA4 days ago$92.2k - $141.4k
...Senior Product Safety & Compliance Engineer The Senior... ...be responsible for leading multiple certification... ...designs employ appropriate risk mitigation solutions.... ...participation in medical device regulatory pathways alongside... ...Devices ISO 13485– Quality Management Systems IEC...QualitySeniorRiskMedical deviceTemporary workLocal areaFlexible hoursShift workNinjakitchen
Needham Heights, MA3 days ago- ...control documentation for combination drug-device and biologic products. The ideal... ...510 years of experience within regulated medical device environments. Responsibilities include... ...supporting product development, and performing risk management. Familiarity with JAMA and...SeniorRiskMedical device
- ...transforming your career.**Device Engineering Sr.... ...Robustness Disciplines Lead.Responsibilities:* Independently... ...to identify risks and mitigations, opportunities... ...with manufacturing, quality, and suppliers to improve... ...within development of Medical Devices, ideally Class...QualitySeniorRiskMedical deviceFlexible hours
- Johnson & Johnson is seeking a Senior Navigation Systems Software... ...Manager in Boston, MA. You will lead an embedded software team... ...navigation systems, ensuring quality, safety, and compliance. The... ...experience and a background in medical devices. This hybrid role involves collaboration...QualitySeniorMedical device
- ...ensuring alignment with program risk and launch readiness... ...manufacturing, and supply chain Lead root cause investigations and... ...consumer electronics or wearable/medical device environments ~ Bachelor's... ...aligns with the same high-quality standards as personal contributions...QualitySeniorRiskMedical device
Whoop
Boston, MA28 days ago $150k
...seeking a highly motivated Senior Internal Auditor to join... ...role will be responsible for leading and executing risk-based audits, SOX audits,... ...and maintain audit quality Required Experience 7+ years... ...financial services, technology, medical devices, or insurance Nice-to-Have...QualitySeniorRiskMedical deviceRemote workProPivotal
Boston, MA3 days ago$126.6k - $189.8k
...Inc (US) is seeking a professional with a strong background in Medical Device and Combination Product Development. The candidate will... ...with cross-functional teams to manage documentation, perform risk analyses, and ensure compliance throughout the design process....SeniorRiskMedical device$150k - $215k
...Senior Technical Program Manager WHOOP is on a... ...managers, regulatory and quality teams, clinical... ...in order to anticipate risks, ask the right questions... ...program managers and leads on partner teams to ensure... ...algorithms for Software as a Medical Device (SaMD), medical device...QualitySeniorRiskMedical deviceFull timeWork at officeRelocationWHOOP
Boston, MA2 days ago$137k - $215.27k
...Description About the role The Senior Manager, Software Device Quality is a seasoned quality and... ...for supporting software medical devices and combination... ...product development teams to lead quality activities across... ...controls, including risk management, design inputs/...QualitySeniorRiskMedical deviceMinimum wageFull timeTemporary workLocal areaWorldwide$147k - $212k
...Job Title: GRA Device Lead (Associate Director) Location: Cambridge... ...diverse team supporting the medical device, combination product,... ...Regulatory Groups, Technical and Quality Groups within R&D and... ...develop device strategies, conduct risk assessments, and serve as the...QualityRiskMedical deviceTemporary workLocal areaWorldwideFlexible hours$155k - $185k
...lives. We are looking for a Senior Program Manager, SaMD to join... ...execution of our Software as a Medical Device programs. This role will... ...Engineering, Clinical, Regulatory, and Quality to plan and deliver against... ...deliverables and identifying risks early Support development in...QualitySeniorRiskMedical deviceFull timeWork at officeRelocationWHOOP
Boston, MA3 days ago- ...Job Summary The Senior CQV Engineer leads commissioning, qualification, and... ..., including plans, risk assessments, IQ/OQ/PQ protocols... ...Engineering, Manufacturing, Quality, Automation, Process... ...pharmaceutical, biotech, medical device, or life sciences environment...QualitySeniorRiskMedical deviceFor contractors
Meet Life Sciences
Watertown, MA4 days ago $105.6k - $158.4k
...focus on developing combination drug-device products. The ideal candidate will have experience in medical device development and a strong understanding of risk management and statistical... ...detailed documentation and adherence to quality standards. The role offers a...QualityRiskMedical device- ...regulated and technically complex medical device landscape. Our work spans a... ...allocation; indirectly lead cross‑functional teams of designers... ...assess, and manage technical risks using a data‑driven approach;... ..., serviceability, quality, and cost. Translate user needs...QualitySeniorRiskMedical device
Delve
Boston, MA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Device Quality Lead - Medical Devices & Risk Mgmt. Be the first to apply!
Related searches
- senior automation controls engineer Cambridge, MA
- senior accounts payable Cambridge, MA
- senior brand designer Cambridge, MA
- senior business analyst contract Cambridge, MA
- senior app developer Cambridge, MA
- senior digital account manager Cambridge, MA
- director sr. director clinical operations Cambridge, MA
- senior specialist Cambridge, MA
- senior research manager Cambridge, MA
- senior account executive Cambridge, MA