Senior Product Development Engineer

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

Job summary

An established industry player is seeking a Senior Product Development Engineer to join their innovative team. This role involves leading complex projects in medical device development, focusing on systems engineering and risk management. The ideal candidate will have extensive experience in product development, strong analytical skills, and a solid understanding of manufacturing processes. Join a forward-thinking company that values creativity and collaboration, where you can make a significant impact on healthcare solutions and contribute to advancing technology in clinical environments.

Qualifications

• 7+ years of experience in medical device development required.
• Bachelor’s degree in Mechanical or Biomedical Engineering preferred.

Responsibilities

• Lead projects of intermediate to high complexity in product development.
• Conduct risk management activities and ensure compliance with regulations.
• Collaborate on prototypes and engage in special assignments.

Skills

Medical Device Development

Risk Management

Analytical Skills

Communication Skills

Knowledge of Manufacturing Processes

DFSS Tools

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Biomedical Engineering

Tools

MiniTab

Job description

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Job Description

The Sr. Engineer will support the Research and Development engineering team within ICU Medical’s Consumables business unit, which includes Vascular Access. The role involves research, development, and implementation of new products with a focus on Systems Engineering and Risk Management.

Position Summary

The Sr. Engineer will independently plan, lead, and complete projects of intermediate to high complexity, serving as a subject matter expert and driving project tasks while adhering to design control processes and good engineering practices. They will develop core competencies in Product Development and mentor cross-functional teams.

Essential Duties & Responsibilities

1. Contribute to project planning, including milestones, schedules, and budgets.
2. Define Systems Architecture, Document Hierarchy, and DHF structure.
3. Plan and execute Voice of the Customer activities; translate User Needs into Design Input Specifications.
4. Establish applicable standards and regulations.
5. Lead risk management activities such as Hazard Analysis.
6. Contribute to design and process FMEAs.
7. Maintain traceability for requirements, risk management, verification, and validation.
8. Research clinical landscape and prior art.
9. Invent practical solutions to advance technology.
10. Collaborate on prototypes with Design and Manufacturing Engineers.
11. Plan feasibility, verification, and validation activities.
12. Establish test plans, protocols, and analyze data for characterization.
13. Support regulatory, sales, and marketing teams as needed.
14. Engage in special assignments and EHS initiatives.
15. Apply root cause analysis, CAPA, and NCR processes.
16. Ensure compliance with global medical device regulations including FDA 510k and EU MDR.

Knowledge & Skills

• Quick learner of new concepts and technologies.
• Hands-on experience in medical device development within a gated process.
• Knowledge of manufacturing processes like machining, metal forming, extrusion, injection molding, etc.
• Analytical skills including DFSS tools, statistical methods, DOE, and MiniTab.
• Familiarity with ISO standards (13485, 14971, 62366, 10555).
• Risk Management expertise is highly desirable.
• Understanding of clinical environments, anatomy, physiology, and biological interactions.
• Strong interpersonal, verbal, and written communication skills.

Minimum Qualifications

• Must be at least 18 years old.
• Bachelor’s degree in Mechanical or Biomedical Engineering or related field, with 7 years of experience; advanced degree preferred.

Work Environment

• Largely sedentary role.
• Office environment with standard equipment.
• Up to 20% travel may be required.

About Us

ICU Medical leads in clinical innovations with a broad portfolio including IV therapy and critical care products, acquired from Hospira Infusion Systems and Smiths Medical, serving hospital, home, and alternate care settings.

EEO Statement

ICU Medical is committed to diversity, inclusion, and equal opportunity employment. Reasonable accommodations are available for applicants with disabilities.