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Process Engineer II

4 months ago

Andover, United States MILLENNIUMSOFT Full time

Position: Process Engineer II

Location : Andover, MA

Duration : 9+ Months contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Level Of Experience: Senior Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1b’s

Up to 5% domestic or international travel

On Site Role

Description:

Job Description – Process Engineer II


At Client Medical – Diabetes Care, a business unit of Becton Dickinson & Co., we are currently strengthening our core capabilities for product development in the field of diabetes management devices. We are looking for a highly innovative, passionate, and talented individual to join our Andover R&D team, where you will have the opportunity to play an important role in the development of BD’s next generation of products for diabetes care.

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