Project Engineer I
| Company | Fresenius Medical Care |
|---|---|
| Location | Andover, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Associate’s |
| Experience Level | Junior |
Requirements
- Associate’s Degree Required; Bachelor’s Degree Desirable
- 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.
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.
Preferred Qualifications
- Bachelor’s Degree Desirable