Senior Product Development Engineer

Smiths Medical; Southington (CT); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Engineer to join their dynamic R&D team in Southington, CT. This role offers a hybrid work schedule and focuses on the development of innovative medical devices. You will leverage your expertise in Systems Engineering and Risk Management to drive projects from conception to execution. As a subject matter expert, you'll collaborate with cross-functional teams, ensuring compliance with industry standards while fostering a culture of continuous improvement. If you are passionate about advancing healthcare technology and possess a strong background in engineering, this opportunity is perfect for you.

Qualifications

• 7+ years experience in Mechanical or Biomedical Engineering.
• Hands-on experience developing medical devices in a gated process.

Responsibilities

• Contributes to project planning and defines Systems Architecture.
• Leads risk management activities and collaborates on prototypes.

Skills

Systems Engineering

Risk Management

Medical Device Development

DFMEA and PFMEA

Statistical Methods

Interpersonal Skills

Communication Skills

Education

Bachelor of Science in Mechanical or Biomedical Engineering

Advanced degree in related field

Tools

MiniTab

Gated Development Process

Job description

Position Summary

This role is based at our Southington, CT facility. A hybrid working schedule is available for this position.

The Sr. 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 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 and Risk Management.

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.

Essential Duties & Responsibilities

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

Knowledge & Skills

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

Minimum Qualifications, Education & Experience

1. Must be at least 18 years of age
2. Bachelor of Science degree from an accredited college or university in Mechanical or Biomedical Engineering or a related field with 7 years experience. Advanced degree in related field preferred.

Work Environment

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