Principal Engineer, Product Development

ICU Medical•Southington, CT

About The Position

The 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. 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.

Requirements

Must be at least 18 years of age
Bachelor of Science degree from an accredited college or university in Mechanical or Biomedical Engineering or a related field.
10+ years of experience
Ability to quickly learn new concepts and technologies
Good interpersonal, verbal and written communications skills.
Proven hands-on experience developing medical devices
Experience leading projects through a gated development process
Comfortable in clinical environments and understands product application: use cases, anatomy, physiology, biological interactions
Knowledge 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 methods
Experience 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.

Nice To Haves

Advanced degree in related field preferred.

Responsibilities

Understands product portfolio and contributes to pipeline strategy and road map
Is actively engaged in project planning: milestones, schedules, budgets, key decisions
Defines Systems Architecture, Document Hierarchy and DHF structure
Plans and executes Voice of the Customer activities followed by analyses and translation to detailed Design Input Technical Specifications
Defines applicable standards and regulations
Quickly identifies and familiarizes with relevant clinical research, competitive landscape and prior art
Invents practical solutions that advance the state of the art
Collaborate with Design and Manufacturing Engineers to develop functional prototypes
Plans feasibility, verification and validation activities with cross functional team
Defines test protocols and methods, and authors reports with data analysis and technical conclusions
Establishes and maintains requirement, risk management, and testing traceability
Able to lead risk management activities such as Hazard Analysis
Contributes 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 collaboration
Completes additional duties and special projects as they arise