Senior Clinical Engineer - Theranostic/ Neuro
GE HealthCare
5d ago
0$100k - $150kDevChina, Germany, India +2 morehimalayas
Clinical-EngineeringMedical-Device-EngineeringRegulatory-AffairsSoftware-EngineeringProduct-ManagementSenior
Job Description
Job Description SummaryThis position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM® to give patients more precise, personalized care.
https://www.mimsoftware.com/
Activities contributing to the design and development of products and their interaction with the human body. Impacts departmental operations and responsible for planning/execution. The role has some autonomy but is focused on execution of activities within an operating discipline covered by standard functional practices and procedures. Some judgment may be required but this is typically with guidance.
**Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.**Job DescriptionWhatYou’llDoDrive the clinical development of imaging products, drug products, diagnostics, and Software as a Medical Device (SaMD) bydeterminingsafety, effectiveness, and clinical value.Translate clinical and customer needs into functional requirements, contribute to software prototyping, supportverificationand validation (V&V) testing, and enable post-market iterative improvements.Lead and contribute to cross-functional projects to ensure product success, including (but not limited to): SaMD regulatory submissions (e.g., 510(k))Sponsored research agreementsProductroadmappingand lifecycle planningDevelop andmaintainin-depth technical and clinicalexpertisewithin your domain through scientific literature review, customer interviews, conference attendance, and clinical site visits.Applystrongunderstanding of key business drivers to execute strategy and deliver results; recognize how your work integrates with other teams and supports broader organizational goals.Exercise judgment to propose solutions beyond established parameters, using prior experience, analytical thinking, and guidance as needed.Collaborate effectively with multidisciplinary internal teams (engineering, regulatory, quality, marketing) and external clinical professionals.Act as a strong individual contributor with proven interpersonal skills, or as an early people leader providing informal mentorship, guidance, and knowledge-sharing to junior team members.WhatYou’llNeedBachelor’s degree from an accredited university or college with an applicable field of study
(e.g., Biomedical Engineering, Radiologic Technology/Sciences, Computer Science, Medical Physics)Master’s or PhD is a plus3+ years of molecular imaging SaMD experienceor5+ years of relevant adjacent experienceStrong problem-solving and analytical abilitiesAbility to communicate and collaborate effectively with: Clinical professionalsEngineering, regulatory, quality, and other multidisciplinary internal teamsAptitude anddemonstratedability to build clinical, anatomical, and technical domain knowledgeWillingness to travel periodically to attend medical conferences, customer meetings, and site visitsPrior software or medical device industry experience is preferred, but notrequiredDesired CharacteristicsStrong self-initiative with a demonstrated growth mindsetEstablished project management skills, including planning, documentation, and executionAbility to mentor junior engineers, delegate appropriately, and support team developmentInvestigates problems with intellectual curiosity and inquisitive passionDemonstrated ability to analyze complex problems and resolve them effectivelyStrong oral, written, and technical communication skillsPreferred QualificationsDirect experience with PET and SPECT imaging softwareDeep understanding of quantitative imaging, particularly in: TheranosticapplicationsRecognized Subject Matter Expert (SME) in advanced molecular imaging softwareMajor contributor to: Regulatory auditsFDA software clearance activitiesExperience with verification and validation (V&V) activitiesStrong technical writing skillsStrong communicationskills, including: Tailoring messages to technical and non-technical audiencesExplaining complex concepts clearly and conciselyCommunicating progress and risks to non-technical stakeholdersProven experience working effectively in a team-based environmentWe will not sponsor individuals for employment visas, now or in the future, for this job opening.For U.S. based positions only, the pay range for this position is $100,000.00-$150,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitiv
