Senior Medical Device Risk Management SME
Alten USA
Alten USA is seeking a Risk Management Subject Matter Expert (SME) in Indianapolis to support medical device risk management. The ideal candidate has at least 8 years of experience and a strong background in Systems Engineering methodologies. This position involves developing and reviewing key risk management deliverables in alignment with applicable standards. U.S. citizenship or permanent residency is required due to client specifications. The role also demands thorough technical documentation skills and the ability to work collaboratively across multiple teams. #J-18808-Ljbffr Alten USA
- ALTEN Technology USA is seeking a Risk Management SME with extensive medical device risk management and systems engineering experience to support development, review, and assessment of risk deliverables for a medical device program. You will review PHA, assist with BE CT...Medical device
- ...the future of space exploration, saving lives with medical devices that set a new standard of care, or creating the... ...employees. Position Summary We are seeking a Senior Systems Engineer - Medical Device Risk Management to support a medical device development program by...SeniorMedical devicePermanent employmentFull time
- ...packaging subject matter expert (SME) during internal audits and... ...and line installations Manage vendor and contractor relationships... ...timeline adherence Support risk assessments (FMEA) for packaging... ...pharmaceutical, biotech, or medical device manufacturing Strong hands‑on...SeniorMedical deviceFor contractors
- ...life—from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3,000... ...to grow. Position Summary We are seeking a Risk Management Subject Matter Expert (SME) with extensive experience in medical device risk...Medical devicePermanent employmentFor contractors
- ...automation subject matter expert (SME) during internal audits and... ..., ensuring appropriate risk assessment and revalidation scope... ...process control optimization Manage vendor and contractor... ...pharmaceutical, biotech, or medical device manufacturing Strong hands‑on...SeniorMedical deviceFor contractors
$162k - $237.6k
...the understanding and management of disease, and give back... ...The purpose of the Senior Director Global Regulatory... ...functions, GRA-CMC, GRA-Devices, and regional... ...workflow, product labeling, risk management, and issues... ...delivery device and relevant medical devices) development,...SeniorMedical deviceFull timeWork at officeLocal areaRemote workFlexible hours- ...Solutions Group Llc is seeking a Technical Project Manager to lead and execute complex technical projects within the medical device sector. The ideal candidate must have a strong... .... You will engage in project planning, risk management, and stakeholder engagement within...Medical device
- ALTEN Technology USA seeks a Senior Risk Management Engineer to drive product safety and regulatory compliance for medical device development. You will work with Systems Engineering, Quality, and Design teams to identify risks, implement mitigation strategies, and ensure...SeniorMedical device
- ...is seeking a highly capable Technical Project Manager to lead and execute complex technical projects within the medical device space. This role requires strong ownership,... ...schedules and targets based on scope changes, risks, or funding considerations Assess schedule impacts...Medical device
- ...support the pharmaceutical, biotech, and medical device industries with our proven, scientific... .... Visit or follow MMS on LinkedIn. Senior Biostatistician: Responsibilities:... ...sponsor, randomization and drug supply management teams. Develop phase 1-4 SAPs and...SeniorMedical deviceRemote work
- ...data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex... ...communicator skills for projects Contribute substantially to, or manages, production of interpretive guides Take ownership of a...SeniorMedical deviceRemote workWorldwide
- ...Senior Territory Sales Manager – Indianapolis OCuSOFT is an Eye Care pharmaceutical company seeking the... ...have a complete focus on delivering medical samples, coupons, literature, and other... ...years of eye care sales or medical sales/device experience (REQUIRED) Able to travel...SeniorMedical deviceMonday to FridayNight shift
- ...is looking to appoint an experienced Senior Project Manager to join its growing team in Indianapolis... ...staff. Identify and manage project risks while driving solutions proactively. Oversee... ...(k) with company match. Comprehensive medical, dental, and vision insurance....SeniorContract workFor contractorsFor subcontractorWork at office
- ...Position Summary As a Materials Manager at ASG, you will collaborate with senior materials management leaders to support... ...and quality within the medical device industry. Key Responsibilities Regulatory... ...compliance and reliability. Risk Management & Product Traceability...Medical device
- ...Senior Managing Counsel, Privacy & Cybersecurity About the Company Multinational life... ...health data compliance. Industry Medical Devices Type Privately Held About the... ...regulatory obligations, and managing legal risks related to data security and privacy....SeniorMedical device
$86.7k
...Senior Program Manager – New Product Development (Carmel, IN – Hybrid) Creating Peace of Mind by Pioneering Safety and Security. Senior Program... ...,000+ employees. Full-time. Engineering Project Manager – Medical Device Startup Develop a point‑of‑care portable blood coagulation...SeniorMedical deviceFull timeFor contractorsInternshipWork at officeWork from home$95k
....00 yearly Full-time Project Manager - Commercial Construction - Greater... ..., retail ... Full-time Senior Configuration Management Analyst... ...This role engages in ongoing risk management of vendors, its... ...involving the relocation of a medical device production line. This...Medical deviceHourly payPermanent employmentFull timeContract workPart timeFor contractorsInternshipImmediate startRemote workRelocation$125k - $165k
...Our Indianapolis team is growing! The Senior Project Controls Manager serves as the team leader on major... ...out administration, earned value and risk management. This position is based out... ...status, AtkinsRéalis benefits may include medical, dental, vision, company‑paid life...SeniorFull timeContract workTemporary workFor contractorsWork at officeRemote workFlexible hours- ...POSITION SUMMARY The Quality Manager is responsible for leading, implementing... ...processes, reduce risk, and ensure quality is built into... ...material, rework, traceability, Device History Records, and quality... ...regulated manufacturing environment (medical device preferred). Minimum of...Medical devicePermanent employmentTemporary workWork experience placementWork at officeImmediate start
- ...Friday - 1st Shift (Day) Responsibilities Manage hiring, coaching, skills development,... ...retention and change control requirements. Lead risk assessments and quality planning... ...Experience in regulated environments such as medical devices, pharmaceuticals, healthcare logistics...Medical deviceWork experience placementMonday to FridayShift workDay shift
$130k - $160k
...mission forward. As a global medical technology leader for nearly... ...Virginia Site Quality leader and Management Representative responsible... ...quality function a medical device design and manufacturing site... ...production employees through senior management. Must possess...SeniorMedical deviceHourly payWork experience placementFlexible hours- ...Job Overview We are seeking an experienced Senior Construction Project Manager to take the lead on high-impact commercial and industrial... ...relationships with clients, architects, and trade partners. Risk Management: Identify project risks early, resolve...SeniorFor subcontractor
$125k - $175k
...Overview MGAC is a global boutique consultancy dedicated to managing and representing our clients’ best interests. This position requires... ...teams while managing schedule, scope, and budget. Lead project risk management, contingency planning, and schedule and budget recovery...SeniorFull timeFor contractorsLocal area- ...makes everything possible. The Senior Quality Control Technician is... ...reports to the Senior Manager - Manufacturing Quality and is... ...finished products and records (Device History Records) meet all requirements... ...research instrument or medical device manufacturing (ISO 1348...SeniorMedical devicePart time
- ...which makes everything possible. The Senior Electrical Engineer is responsible for... ...Global Procurement Resiliency Engineering Manager and is part of the Global Procurement... ...design control/change environment for medical devices. Working with microcontrollers and programmable...SeniorMedical devicePart time
- ...(PCI) team! We are seeking a Senior Calibration Technician that can... ..., pressure and temperature devices. Computer based calibration tracking... ...directly to the Team Leader, Manager, or Director depending on the... ..., biotechnology, medical device, and clinical research...SeniorMedical deviceRelocationRelocation package
- ...operational leadership, ensuring all projects meet key objectives like safety and financial goals. This includes managing client relationships and driving risk management. Candidates should have significant experience in construction management, with strong communication...Senior
- ...Senior Vice President, Reinsurance Contract Drafting About the Company Acclaimed provider of bespoke risk management, insurance & consulting services Industry Insurance Type Public Company Founded 1927 Employees 1001-5000...SeniorContract workWork at office
- ...Associate. Essential Duties Lead Audit Engagements: Oversee and manage audit assignments, including planning and execution. Review Financial... ...Controls: Assess the effectiveness of internal controls and risk management processes. Prepare Reports: Create detailed audit...SeniorWeekend work
- ...Technical Services is undergoing rapid growth, and we are seeking Senior Project Managers with the leadership experience and technical expertise to... ...small cell installations, and wireless tower builds Manage risk management, permitting, and client communications throughout...SeniorContract workFor subcontractorLocal area
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