Sr. Engineer, R&D
Position Summary
The Engineer III will support the Research and Development engineering team within ICU Medical’s Consumables business unit which includes Vascular Access and Oncology products. As part of this team you will contribute to the research, development, and implementation of new products using specialized knowledge and skills typically acquired through advanced education. There will be an emphasis on Systems Engineering: planning requirements management, establishing user needs, design inputs and tracing of design verification.
The Engineer III works on projects/matters of intermediate to high complexity working independently or with a team. Receives technical mentorship on complex problems, and can effectively collaborate or work independently for resolution using new, improved or novel approaches and solutions. The Engineer III will be expected to develop into a 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 Engineer III will be enthusiastic to develop their Product Development core competencies and to contribute to projects working within a cross functional team.
Essential Duties & Responsibilities
- Participates in Voice of the Customer activities, analyses and translation to Design Input Technical Specifications
- Defines Requirements Plan, Systems Architecture, Design Inputs and DHF structure
- Maintains traceability between requirement, risk management, and verification documents
- Contributes to project planning: milestones, schedules, budgets, key decisions
- Contributes to risk management activities such as hazard analysis and design failure and effects analysis (DFMEA)
- Plans feasibility, verification and validation activities in collaboration with cross functional team
- Identifies and familiarizes with relevant clinical research, competitive landscape and prior art
- Invents practical solutions that advance the state of the art
- Collaborates with Design and Manufacturing Engineers to develop functional prototypes
- Recommends and enforces design for compliance to applicable standards and regulations for medical devices
- 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.
Knowledge & Skills
- Ability to quickly learn new concepts and technologies
- Proven hands-on experience developing medical devices in a gated development process
- Experimental, computational and analytical skills such as DFSS tools, statistical methods including design of experiments (DOE) and MiniTab
- Knowledge of manufacturing processes: machining, metal forming, extrusion, injection molding, common joining methods, etc.
- Solidworks (CAD) and DOORS or JAMA (requirements management) experience nice to have
- Experience with Sustaining Engineering projects: root cause analysis, CAPA and NCR processes, DHF remediation, customer inquiries.
- Familiarity with ISO standards, including 13485, 14971, 62366, 80369 and 10555.
- Experience with global medical device regulations including FDA 510k and EU MDR (Medical Device Regulation)
- Comfortable in clinical environments and understands product application: use cases, anatomy, physiology, biological interactions
- Good interpersonal, verbal and written communications skills.
Minimum Qualifications, Education & Experience
- 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 with 4 years experience. Advanced degree in related field preferred.
Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- May require travel up to 20% of the time
Engineering
Primary Location
US-CT-Southington
Schedule
Full-time
Shift
Day Job