{"id":1599825,"url":"https://alion.io/job/biotronik-clinical-studies-engineer-ii","title":"Clinical Studies Engineer II","company":{"id":1828745,"name":"Biotronik","domain":"biotronik.com","url":"https://alion.io/company/biotronik-com","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Lake Oswego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":76000,"max_usd":138000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-10-01T18:56:55Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-27T13:48:55Z","board_verified":true,"closed_at":null,"days_open":26,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":26},"description":"[[title]]\nBIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.\nBIOTRONIK is seeking a Clinical Studies Engineer II to join our Clinical Studies team. In this role, you will play an important part in the planning, execution, and successful completion of clinical investigations involving innovative medical device technologies. You will develop an in-depth understanding of BIOTRONIK products, clinical procedures, and relevant therapeutic areas while serving as a clinical and technical resource for investigative sites, field personnel, and internal stakeholders. Working collaboratively with cross-functional teams, investigators, and study sites, you will support clinical investigations throughout the study lifecycle, including protocol development, study initiation, enrollment, data analysis, clinical reporting, and regulatory submissions. This role offers the opportunity to contribute to the development of clinical evidence supporting BIOTRONIK technologies while helping ensure the successful and compliant conduct of clinical studies.\nYour Responsibilities\nClinical Study Management & Execution\nParticipate in all phases of clinical investigations, including study design, initiation, enrollment, study execution, data analysis, and clinical report writing.\nLead the development and revision of clinical study protocols.\nDesign case report forms (CRFs) to support accurate, comprehensive data collection and analysis in accordance with study protocols.\nDevelop study documents, training materials, and other resources supporting clinical protocols, study procedures, and CRF completion.\nProvide day-to-day study management and support to investigative sites.\nServe as a clinical and technical resource for site coordinators, investigators, field clinical personnel, sales representatives, and other internal stakeholders.\nTrain investigative sites and BIOTRONIK personnel on clinical protocols, investigational devices, study procedures, and data collection requirements.\nSupport sites and field personnel in collecting complete, accurate, timely, and compliant clinical data.\nReview and/or monitor case report forms, source documents, and other study records in accordance with BIOTRONIK procedures and applicable regulatory requirements.\nCollaborate with study teams, field personnel, and investigative sites to resolve data discrepancies, compliance concerns, and regulatory issues.\nIdentify and report significant protocol compliance issues and support appropriate resolution.\nDevelop solutions to logistical and operational challenges that arise during study execution and communicate recommendations to appropriate stakeholders.\nBuild and maintain strong professional relationships with investigators and investigative sites.\nData Analysis, Reporting & Regulatory Support\nPartner with Clinical Data Operations to clean, organize, summarize, and analyze complex clinical data.\nGenerate clinical reports and contribute to scientific publications.\nSupport preparation of clinical content for FDA submissions.\nParticipate in FDA meetings as a clinical representative when needed, including presenting and explaining device features, clinical study design, and study results.\nProduct & Technical Expertise\nDevelop an in-depth understanding of BIOTRONIK products and associated clinical procedures, which may include technologies within cardiac rhythm management, vascular intervention, and/or spinal cord stimulation.\nDevelop training and clinical study support materials for investigational or study devices and procedures.\nCollaborate with Advanced Product Support and other internal teams to address technical and study-related questions.\nAttend device implants and/or follow-up procedures as needed to remain current on devices, clinical utilization, and patient care.\nProvide clinical and technical feedback to Engineering and Research & Development teams as needed.\nContribute clinical expertise to new project planning and development initiatives.\nSupport the training and mentoring of newly hired Clinical Studies Engineers.\nProvide support to other clinical studies and projects as business needs require.\nWhat We're Looking For\nRequired Qualifications\nBachelor's degree in a health profession, science, engineering, or related field with a strong technical and clinical background.\nWorking knowledge of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), and other regulations and standards governing clinical research.\nDemonstrated ability to develop expertise in relevant therapeutic areas and quickly learn and integrate knowledge of new technologies and clinical applications.\nStrong written and verbal communication, presentation, and interpersonal skills.\nExcellent organizational skills and attention to detail.\nAbility to manage multiple priorities and work effectively both independently and as part of a cross-functional team.\nStrong computer skills and ability to work effectively with clinical study data and documentation.\nClinical Studies Experience\nCandidates must meet one of the following:\nMore than three years of successful experience as a Clinical Studies Engineer I within BIOTRONIK's Clinical Studies department, along with completion of Clinical Studies Certification in a product area of primary study support; or\nComparable clinical studies experience with another organization in a similar position or relevant field.\nPreferred Qualifications\nMaster's degree in a health profession, science, engineering, or related discipline.\nExperience in a clinical setting, biostatistics, IDE clinical studies, and/or medical device support.\nPrevious experience supporting medical device clinical investigations.\nWork Location\nWork location is hybrid out of our Lake Oswego, Oregon campus -or- remote within the United States based on skill set and qualifications.\nTravel Requirements\nTravel is generally limited to less than two weeks per year for clinical procedures, investigative site training, and meetings. Depending on study needs and the phase of a clinical investigation, travel may periodically increase to up to 25%.\nPhysical Requirements\nThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nWhile performing the duties of this job, the employee is regularly required to be independently mobile.\nThe employee is also required to interact with a computer for extended periods of time, and communicate with co-workers.\nMust be able to work a minimum of 40 hours / week.\nMust be able to travel \nAre you interested? Please apply online through our application management system! We are looking forward to welcoming you.\nLocation: Lake Oswego, OR | Working hours: [[filter3]] | Type of contract: [[filter2]]\nApply now under: www.biotronik.com/careers\nJob ID: [[id]] | [[mfield1]]| [[recCompany]]\nWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. 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