Principal Engineer, Product Development - Medical Device

Position SummaryThe Principal Engineer will support the Research and Development engineering team within ICU Medical’s Consumables business unit which includes Vascular Access. As part of this team, you will have a lead role in the development and implementation of new products using specialized knowledge and skills typically acquired through advanced education. This is a technical leadership role that is expected to define, deliver and drive best in class deliverables through deep domain experience and subject matter expertise in the development of medical device products, with emphasis on requirements development and requirements management. The Principal Engineer will be expected to lead and execute highly complex projects and consistently show progress developing their Product Development core competencies. You will also be enthusiastic to direct, coach, mentor and align a cross functional team as needed.Essential Duties & ResponsibilitiesUnderstands product portfolio and contributes to pipeline strategy and road mapIs actively engaged in project planning: milestones, schedules, budgets, key decisionsDefines Systems Architecture, Document Hierarchy and DHF structurePlans and executes Voice of the Customer activities followed by analyses and translation to detailed Design Input Technical SpecificationsDefines applicable standards and regulationsQuickly identifies and familiarizes with relevant clinical research, competitive landscape and prior artInvents practical solutions that advance the state of the artCollaborate with Design and Manufacturing Engineers to develop functional prototypesPlans feasibility, verification and validation activities with cross functional teamDefines test protocols and methods, and authors reports with data analysis and technical conclusionsEstablishes and maintains requirement, risk management, and testing traceabilityAble to lead risk management activities such as Hazard AnalysisContributes to design and process failure and effects analyses (DFMEA and PFMEA)Communications tailored to various audiences with appropriate frequency and detail to maximize utility and promote cross-functional collaborationCompletes additional duties and special projects as they arise.This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement. Knowledge & SkillsAbility to quickly learn new concepts and technologiesGood interpersonal, verbal and written communications skills. Proven hands-on experience developing medical devicesExperience leading projects through a gated development processComfortable in clinical environments and understands product application: use cases, anatomy, physiology, biological interactionsKnowledge of manufacturing processes: extrusion, injection molding, machining, metal forming, joining methods, inspection, etc.Experimental, computational and analytical skills such as DFSS tools, MiniTab software and statistical methodsExperience with root cause analysis, CAPA and NCR processes.Experience with global medical device regulations including FDA 510k and EU MDR (Medical Device Regulation)Familiarity with ISO standards, including 13485, 14971, 62366, and 10555. Minimum Qualifications, Education & Experience Must be at least 18 years of ageBachelor of Science degree from an accredited college or university in Mechanical or Biomedical Engineering or a related field. Advanced degree in related field preferred.10+ years of experience