Position Summary
JOB DESCRIPTION
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.
Essential Duties & 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.
- 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 & Skills
- 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.
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. Advanced degree in related field preferred.
- 10+ years of experience
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 15% of the time
About Us
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement
ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
ICU Medical EEO Policy Statement
Know Your Rights: Workplace Discrimination is Illegal Poster
ICU Medical CCPA Notice to Job Applicants
