Senior Engineer, Product Development

ICU Medical•Southington, CT

About The Position

The Senior 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 pivotal role in the development, and implementation of new products using specialized knowledge and skills typically acquired through advanced education. There will be an emphasis on Systems Engineering. The Sr. Engineer can plan, lead and complete projects/matters of intermediate to high complexity working independently or with a team. Receives technical mentorship on complex problems, but independently resolves using new, improved or novel approaches and solutions. The Senior R D Engineer will be expected to serve as the subject matter expert on a variety of topics. They will drive actionable project level tasks while adhering to established design control processes and good engineering and documentation practices. The Sr. Engineer will be enthusiastic to develop their Product Development core competencies as well as their ability to direct, coach, mentor and align a cross functional team as needed.

Requirements

Ability to quickly learn new concepts and technologies
Proven hands-on experience developing medical devices in a gated development process
Knowledge of manufacturing processes: extrusion, injection molding, machining, metal forming, common joining methods, inspection, etc.
Experimental, computational and analytical skills such as DFSS tools, MiniTab software and statistical methods including design of experiments (DOE)
Familiarity with ISO standards, including 13485, 14971, 62366, and 10555.
Comfortable in clinical environments and understands product application: use cases, anatomy, physiology, biological interactions
Good interpersonal, verbal and written communications skills.
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.
Minimum of seven years experience required.

Nice To Haves

Advanced degree in related field preferred.

Responsibilities

Contributes to project planning: milestones, schedules, budgets, key decisions
Defines Systems Architecture, Document Hierarchy and DHF structure
Identifies and familiarizes with relevant clinical research, competitive landscape and prior art
Plans and executes Voice of the Customer activities, defines and translates User Needs to Design Input Technical Specifications
Defines applicable standards and regulations
Leads risk management activities such as Hazard Analysis
Contributes to design and process failure and effects analyses (DFMEA and PFMEA)
Maintains requirement, risk management, and verification / validation traceability
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 in collaboration with cross functional team
Performs characterization as required: establishes test plans, writes test protocols and methods, and authors test reports with data analysis and technical conclusions.
Provides technical support to regulatory, sales, marketing and other functional areas as needed.
Work on special assignments as they arise
Engages others, promotes, and participates in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
Experience with root cause analysis, CAPA and NCR processes.
Experience with global medical device regulations including FDA 510k and EU MDR (Medical Device Regulation)