Project Engineer I

Position Location Details - Upon agreement between you and your supervisor, you are entitled to a flexible arrangement where you will be able to split your time between working from the office and working remotely.

PURPOSE AND SCOPE

The Project Engineer I (Fluids) assists in the development and design of products, product improvements, processes and equipment, the design of testing protocols for the new or existing products that are applicable and acceptable to industry expectations/requirements. Participates in cross-functional teams on product product sustaining activities and manufacturing problem-solving efforts. Creates presentations based on this data for product introduction purposes.

PRINCIPAL DUTIES AND RESPONSIBILITIES

· Develops, analyzes, and writes test protocols, test results, product specifications, sub-systems requirements and Engineering Test Reports (ETRs) summarizing results from multiple experiments.

· Leads exploratory testing to identify product and design deficiencies and redundancies (Disposables).

· Contributes to generation of ideas and inventions to be used in new and existing products.

· Sets up, adjusts, and operates laboratory equipment and instruments. Specific equipment familiarity depends on technical scope.

· Assists with testing products for compliance and standards

· Develops and revises Standard Operating Procedures (SOP's) and Test Methods (TM's).

· Creates Change Orders and Deviations

· Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

· May escalate difficult/complex issues to supervisor for resolution, as deemed necessary.

· Supports Manufacturing Engineering, Quality, Failure Analysis, and Production on issues as needed.

· Updates management on product sustaining support to the Field and Failure Analysis, Production, and Manufacturing Engineering.

· Assists with various projects as assigned by direct supervisor.

· Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location-specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS

· The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

· Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Occasionally lift and/or move up to 50 lbs. with assistance.

EDUCATION

• Associate’s Degree Required; Bachelor’s Degree Desirable

EXPERIENCE AND REQUIRED SKILLS

· 1-2 years’ related experience.

· Excellent oral and written communication skills.

· Knowledge of standard laboratory test and measurement equipment and tools.

· Strong PC skills with Microsoft Office applications knowledge.

· Ability to read engineering documentation (mechanical).

· Familiarity with FDA standards including design control and managing design history file (DHF).

· Familiarity with international standards (ISO, ASTM, etc.).

· Thorough understanding of HD and PD systems.

· Highly motivated and energetic. Passion for creating high-quality medical device systems.

· Strong interpersonal skills with ability to work effectively in a team or individually with supervision.