Senior Engineer, Product Design

ICU Medical • Southington, CT

10h • Hybrid

About The Position

The Senior Engineer position in the Vascular Access Product Engineering group is
responsible for managing the post launch life cycle for products that have been
released for sale. This includes analyzing change requests and implementing a
change management plan, investigating and correcting non-conforming events,
including Corrective Actions and Preventative Actions, remediating design
history files to conform to new regulatory requirements, and developing line
additions to expand the scope of a product portfolio. The Senior Engineer works
on projects/matters of advanced complexity with cross functional support and
often works independently of managerial staff.

Requirements

• Able to solve technical problems using engineering principles and analytical ability using advanced methodologies, creativity and best practices.
• Able to critically review and interpret technical documentation such as engineering drawings and component specifications.
• Able to work accurately with attention to detail.
• Able to handle multiple priorities and meet key deadlines under pressure through effective time management skills.
• Able to communicate professionally to technical and non-technical internal and external customers, including executive management, through conversations, presentations, and formal and informal electronic media.
• Able to build consensus across project or engineering teams with well-reasoned arguments in a collaborative effort to resolve conflicts or to develop new strategies.
• Able to act as a subject matter expert in a product and/or technical area and have broad knowledge in related areas of expertise.
• Able to provide technical input into strategic business decisions and use commercial awareness to make key technical decisions.
• Must be at least 18 years of age.
• Bachelor’s degree in mechanical or biomedical engineering from an accredited college or university is required.
• Minimum of seven years of work-related experience
• Must hold a valid driver’s license as well as comply and meet the requirements set forth in the Authorized Driver Policy to drive on behalf of the company.

Responsibilities

• Organizes, plans, and executes activities related to implementing design changes per change management plans and company procedures.
• Writes test protocols, performs test method validations and executes test plans, and authors test reports with data analysis and technical conclusions.
• Updates design output documents such as engineering drawings, purchasing specifications, and bill of materials.
• Completes risk management activities through hazard analysis and design failure and effects analysis (DFMEA) and identifies and implements risk mitigation.
• Provides technical support to regulatory, sales, marketing and other functional areas as needed.
• Helps lead investigations of root causes leading to non-compliance events arising from design, manufacturing, procedural or customer use.
• Provides technical support as a Subject Matter Expert for a particular Product Family
• Works on special projects as assigned.
• Mentors junior members of the engineering staff including interns and/or cooperative students, or co-ops

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level