Position : Process Test Engineer II

Location : Andover, MA

Duration : 5 Months

Total Hours/week : 40.00

1^st Shift

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Mid-Level

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 electro-mechanical 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, FMEA’s, risk / hazard analysis, and similar efforts
• Work with upstream and downstream stakeholders to create designs that meet customer expectations and high-volume 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 hands-on design skills with mechanical components and assemblies
• Strong analytical and problem-solving skills
• Strong experimental skills leveraging proven DFSS techniques
• Proficiency in SolidWorks or other equivalent 3-D CAD modeling software and familiarity with drawing standards
• Basic understanding of structured Product Development process
• Strong self-management, prioritizing and multi-tasking skills, ability to set and meet deadlines

Note:

Up to 5% domestic or international travel