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Staff R&D Engineer
Employment Type:
Contract to Hire
Category: Mechanical Engineer
Job Number: 11059
Pay Rate: $70/hr - $75/hr
Job Description
Qualifications
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Bachelor's in Mechanical Engineering, Biomedical Engineering, or a related field with 10+ years of medical device experience, or an advanced degree with 9+ years
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Proven track record taking designs from concept through commercialization, applying DFX principles to scale
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Design expertise in two or more of: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics
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Proficiency in SolidWorks, design for manufacturability, tolerance stack analysis, and GD&T
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Experience with design of experiments (DOEs) and statistical data analysis; simulation experience (CFD, FEA) a plus
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Working knowledge of ISO 13485 and FDA 21 CFR Part 820, plus sterilization and biocompatibility testing in a regulated industry
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Experience leading technical teams and mentoring engineers
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Strong collaboration, communication, and hands-on problem-solving skills; must comply with applicable vaccination requirements
Responsibilities
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Lead design and development of new single-use devices and accessories, serving as technical lead and, when needed, core team lead
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Keep all design work compliant with design controls, partnering cross-functionally to ensure manufacturability, reliability, and scalability
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Build prototypes, design fixtures, run feasibility studies, and execute testing to guide product decisions
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Solve engineering problems through root cause analysis and data-driven methods
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Define and lead qualification strategies for new designs and processes, aligning with teams across the organization
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Translate customer needs into product requirements and engineering specifications
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Develop test methods, write and execute protocols, and author reports and risk documentation
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Manage suppliers and coordinate external sterilization, packaging, and biocompatibility testing; communicate progress, results, and risks to stakeholders