Senior Engineer, Product Development

Position Summary

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.

• 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)

• 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, Mini Tab 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. Advanced degree in related field preferred.

• This is largely a sedative role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• May require travel up to 20% of the time