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Company Contact Info
- Westborough, MA
- Mathusha G
- Phone: 973-804-4236
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Mechanical Engineer II- Life cycle engineering
Collabera • Westborough, MA
Posted 13 days ago
Travel - None
Energy - Utilities - Gas - Electric
Relocation - No
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-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.
- 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.
- 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
- 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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