Product and Process Development Engineer

Product and Process Development Engineer

Direct message the job poster from Agile Search Inc.

People, Purpose & Performance | Precision Hiring | Career Alignment

Mid-Senior R&D / Process Engineering opportunity with an established and growing device company developing a new line of advanced catheters that deliver the latest in ablation therapies.

About the Role

This is a critical hire with a focus on developing robust device designs and processes for commercialization. The successful candidate in the position will develop new catheters and improve the design and manufacturing processes of current products.

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

Qualifications

• 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

Required Skills

• Experience developing endoscopic, vascular or cardiac catheter systems is a plus
• Competence using Solid Works 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 Skills

• 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

We are committed to diversity in our hiring practices.

Seniority level:
Mid-Senior level

Employment type:

Full-time

Job function:
Medical Equipment Manufacturing

Norwood, MA $79,500.00-$ 2 days ago