Process Engineer
Description:
Position : Process Engineer
Location : Andover, MA
Duration : 7 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Engineering
Level Of Experience: Mid-Level
Employment Type: Contract on W2 (Need US Citizens Or GC Holders )
Description:
Job Summary:
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
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
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
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
Up to 5% domestic or international travel