Process Engineer II
Job in
Andover, Essex County, Massachusetts, 05544, USA
Listed on 2026-06-14
Listing for:
MillenniumSoft Inc
Full Time
position Listed on 2026-06-14
Job specializations:
-
Engineering
Manufacturing Engineer, Mechanical Engineer, Product Engineer, Quality Engineering
Job Description & How to Apply Below
Client: Medical Device Company
Position: Process Engineer II
Location: Andover, MA
Employment Type: Contract on W2 (US Citizens or GC holders only)
Travel: Up to 5% domestic or international
Shift: 1st Shift
Duration: 5+ months contract
Total Hours/week: 40
Job SummaryThe 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- 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
- 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, Mat Lab, Minitab etc.
- Understanding of engineering principles and the ability to apply advanced engineering techniques to solve complex technical problems
- 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
Skills And Abilities
- Strong hands-on design skills with mechanical components and assemblies
- Strong analytical and problem-solving skills
- Proficiency in Solid Works 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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