Agile Search Inc. · 2 weeks ago
Manufacturing Development Engineer
Marlborough, MA
Full-time
Onsite
Mid, Senior Level
$138K/yr - $148K/yr
3+ years expAgile Search Inc. is an established and growing device company developing a new line of catheters delivering cutting edge therapies. They are seeking a Manufacturing Development Engineer to focus on developing robust device designs and processes for commercialization, improving the design and manufacturing processes of current products.
Human Resources
Hiring Manager
John Compton
Responsibilities
Design for Manufacture and scalability of components and subsystems for complex catheter technologies
Create 3D models and technical drawings
Develop, optimize, transfer manufacturing and assembly processes from R&D to Manufacturing and perform process validations
Perform Design of Experiments, write and execute test methods, protocols, reports
Provide statistical analysis of data
Assemble and build prototypes and fixtures
Work with vendors of catheter components, sub-assemblies, and services
Qualification
Required
BS or MS in Mechanical, Manufacturing, Plastics, or Biomedical Engineering
Three to eight years of successful experience in product and process development of complex catheter systems
Experience developing endoscopic, vascular or cardiac catheter systems is a plus
Competence using SolidWorks for modeling, shop and fabrication hand tools
Understanding and use of statistics for design applications and process controls
Ability to write clear reports, specifications, and proposals, and effectively discuss them with a multi-disciplinary team that includes R&D, Manufacturing, Quality, Clinical, and Marketing
Strong knowledge of regulatory requirements for medical device development and launch
Preferred
Strong knowledge of catheter fabrication and manufacturing techniques and processes
Knowledge or experience processing polymer and metal catheter materials, e.g. Pebax, nylon, PTFE, FEP, PEEK, Nitinol, Steel
Experience developing endoscopic, vascular or cardiac catheter systems is a plus
Experience with UV and Solvent Bonding, Reflow, Extrusion, Injection Molding, Machining, Additive Manufacturing, Swaging, Tipping
Company
Agile Search Inc.
The Agile Search mission is to help our partner companies build unstoppable teams.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
John Compton
Founder and President
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