Process Engineer II
MillenniumSoft Inc · Andover, MA · 25 mo ago
ManagementFull-time
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 ability to apply advanced engineering techniques to solve complex technical problems
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