Principal Engineer, Mechanical

ICU Medical is currently hiring a Principal Engineer, R&D in Southington, CT.

The Principal Engineer will support the Research and Development engineering team within ICU Medical's Consumables business unit which includes Vascular Access and Oncology products. This role will support all R&D engineering aspects of the product development process as well as post market activities. The Principal Engineer plans, leads and completes complex projects and directs, coaches, mentors and aligns a cross functional team as needed.

This is a technical leadership role in engineering that is expected to have deep domain experience in the development and maintenance of medical device products, with strong emphasis on requirements development and requirements management. The Principal Engineer will be expected to lead and execute on key projects and consistently show progress developing their Medical Device Product Development core competencies.

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 Requirements Plan, Systems Architecture and DHF structure

• Plans and executes Voice of the Customer activities followed by analyses and translation to detailed Design Input Technical Specifications

• Understands product application: use cases, anatomy, physiology, biological interactions

• Quickly identifies and familiarizes with relevant clinical research, competitive landscape and prior art

• Invents practical solutions that advance the state of the art

• Experience with wide range of manufacturing processes and materials

• Collaborates with Design and Manufacturing Engineers to develop functional prototypes

• Plans verification and validation activities in conjunction with Testing and HFE personnel

• Establishes and maintains requirement, risk management, and testing traceability

• Working knowledge of DFSS tools and Engineering theory to drive best practices and successful outcomes

• Completes and drives best in class deliverables

• Completes additional duties and special projects as they arise.

• Communications tailored to various audiences with appropriate frequency and detail to maximize utility and promote cross-functional collaboration

• Familiarity with ISO standards including 13485, 14971, 62366, 80369 and 10555.

• Experience with global medical device regulations including EU MDR (Medical Device Regulation)

• Experience with FDA 510k process

• Experience leading projects through a gated development process

• Experience with Sustaining Engineering projects: CAPA and NCR processes, DHF remediation, customer inquiries.

• Comfortable in clinical environments

• 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.

DIVERSITY & INCLUSION

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

THE INDIVIDUAL

• Bachelor's degree from an accredited college or university in Engineering. Mechanical or Biomedical Engineering degrees preferred. Advanced degree in related field preferred.

• 10 years of experience

• Experience in medical device product development preferred

• Has deep knowledge of best practices. Has subject matter expertise on engineering discipline.

• Company leader in your domain of expertise. Quickly and easily obtain effective expertise within scope of influence.

• MiniTab and statistical experience preferred.

• Solidworks experience nice to have

Travel Requirements

• Typically requires travel less than 10% of the time

Physical Requirements and Work Environment

• This is largely a sedentary role.

• This job operates in a professional office environment and routinely uses standard office equipment.

• This job is partially remote.

SALARY & BENEFITS

In addition to a competitive compensation package, ICU Medical offers a comprehensive benefit package including Medical, Dental, Vision, 401K and much more!

Primary Location: US-CT-Southington

Schedule: Full-time

Shift: Day Job