Position : Process Test Engineer II
Location : Andover MA
Duration : 5 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Engineering
Level Of Experience: MidLevel
Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
Mon Fri 8AM 5PM
Job Description:
- The Engineer II will support the team in design development and commercialization of new diabetes care products.
- This talented and passionate individual will be responsible for delivering innovative and practical solutions that support the product development road map.
Responsibilities include but not limited to the following:
- Perform complex testing of electromechanical devices to inform product development and root cause analysis efforts collect and analyze data
- Contribute to mechanical design of disposable and durable system items including prototypes tooling and test fixtures and support development of manufacturing equipment and processes
- Support efforts in creation of specifications and test methods for new products
- Employ DFSS principles to devise and execute tests to drive development
- Use first principles and advanced engineering methods to guide the development process
- Perform 3D modeling and tolerance analysis of complex electromechanical systems
- Support design reviews FMEAs risk / hazard analysis and similar efforts
- Work with upstream and downstream stakeholders to create designs that meet customer expectations and highvolume manufacturing requirements
Minimum Qualifications:
- MS or BS in Engineering (Mechanical or Biomedical preferred)
- Hands on experience building prototypes and fixturing machine shop experience a plus
- Working knowledge of DFSS tools and methods
- Highly desirable to have experience with data acquisition analysis and statistical techniques using LabVIEW MatLab Minitab etc.
- Understanding of engineering principles and be ability to apply advanced engineering techniques to solve complex technical problems
Desired Qualifications:
- 1 to 3 years of experience with some work in new product development preferred
- Experience designing high volume disposable products especially in plastic
- Exposure to product and process validation including V&V TMV FAI FAT/SAT IQ/OQ/PQ etc.
- Knowledge of Design of Experiments (DOE) Design for Six Sigma (DFSS) Design for Manufacturing/Assembly (DFMA)
- Familiarity with materials used in medical devices (best practices biocompatibility)
- Experience with designing for manufacturing (DFM)
- Experience with ISO requirements and GMP guidelines FDA regulations medical device design control and manufacturing scale up processes
Knowledge Skills and Abilities:
- Strong handson design skills with mechanical components and assemblies
- Strong analytical and problemsolving skills
- Strong experimental skills leveraging proven DFSS techniques
- Proficiency in SolidWorks or other equivalent 3D CAD modeling software and familiarity with drawing standards
- Basic understanding of structured Product Development process
- Strong selfmanagement prioritizing and multitasking skills ability to set and meet deadlines
Note:
Up to 5 domestic or international travel