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SoloPoint Solutions, Inc.
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USD
150000
200000
YEAR
true
Principal Mechanical Engineer
2025-04-16
2025-05-19
Employment Type:
Direct
Category: Mechanical Engineer
Job Number: 10365
Pay Rate: $150K - $200K
Job Description
Qualifications:
- BSME, 15+ years of working experience
- Experience in design of biotech or medical consumables/disposables
- Extensive experience in plastic injection molding process, knowledge of tooling design, materials, material properties, DFM
- Familiarity with FDA quality requirements (ISO 13485, cGMP, QMS standards, USP class VI (biocompatibility testing))
- Proficiency in SolidWorks CAD
- Experience in designing test fixtures to support V&V
- Ability to travel to vendor locations overseas as needed
- Responsible for the design, development, prototyping, and volume manufacturing of complex injection molded assemblies and high-precision mechanical components & assemblies
- Specifying injection molding tooling with state-of-the-art capabilities: Variotherm, vacuum assist, hot runners, etc
- Design and development of manufacturing test fixtures as required
- Identify & interface with key component vendors (suppliers of tubing, valves, etc., that may be integrated into our consumable design)
- Interface with R&D systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economically