Process Engineer II

2 weeks ago

Andover, Massachusetts, United States MILLENNIUMSOFT Full time
Job Title: Process Engineer II

We are seeking a highly skilled Process Engineer II to join our team at MillenniumSoft. As a Process Engineer II, you will play a key role in the design, development, and commercialization of new products.

Job Summary:

The successful candidate will be responsible for delivering innovative and practical solutions that support the product development roadmap. This includes performing complex testing of electro-mechanical devices, contributing to mechanical design, and supporting efforts in creation of specifications and test methods for new products.

Responsibilities:
  • 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
Requirements:
  • 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

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