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Mechanical Engineer II- Life cycle engineering

Collabera • Westborough, MA

Posted 13 days ago

Job Snapshot

Contractor
Travel - None
Energy - Utilities - Gas - Electric
Design
Relocation - No
32

Applicants

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Job Description

-Essential Responsibilities Engineering:

  • Design of plastic components, assemblies, packaging, tooling and fixtures; analyze and validate tolerances, performance, cost and manufacturability. Source components.
  • Supports designing products to meet their intended use. Ensure performance of engineering analyses (support / coordinate and review FEA, CFD analyses) to aid in making design decisions.
  • Create detail and assembly drawings and associated Bill-of-Materials.
  • Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, and write and present verification reports.
  • Create manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.
  • Leadership:
  • Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
  • Interface with a cross-functional team to resolve issues.
  • Interface with customers and cross-functional groups for complaint investigations, drive root cause analysis and implement quality and design related improvements.
  • Release products through the ECR/ECO process.
  • Maintain safe work area.

Job Requirements

Qualifications/Requirements:

  • Bachelor’s degree in either; Mechanical Engineering, Plastics Engineering, or BioEngineering
  • 1 to 2 years of relevant experience in Mechanical engineering, Biological Sciences, Biotechnology, medical device development or a related field
  • Proficient in SolidWorks or Pro/Engineer CAD (preferably SolidWorks)
  • Plastic part design and drafting GD&T per ASME Y14.5 standards
  • Working experience with plastics and relevant material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
  • Basic understanding of materials, properties, Mfg. processes, and product assembly
  • Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy
  • Experience in developing DOE (Design of Experiments) test protocols and reports
  • Experience in Root Cause Analysis for investigations
  • Ability to write reports; communicate test analysis and results
  • Familiarity with relevant regulatory and QA guidelines governing implementation and use of disposable materials and components.
  • Hands-on experience designing, prototyping and testing and implementing components and designs.
  • Proficient with Microsoft Word, Excel, PowerPoint
  • Good communication and writing skills for working

 

 

Desired Characteristics:

  • Six Sigma Greenbelt or Blackbelt Certification
  • Proficient with Microsoft Project and Visio is desired
  • Experience in FEA, CFD and MoldFlow analysis CAE tools
  • Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications
  • Experience in leading projects/activities to meet customer requirements
  • Use of DFSS in designing products
  • Application of risk management methodologies to aid in meeting commitments
Job ID: 4236_MD_MA
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