Sr Process Engineer

Job Description :

PRIMARY RESPONSIBILITIES : ·Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions through frequent interaction with R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies.

· Develop fixtures, tooling, and equipment.

· Develop process specifications which ensure user needs are met.

· Perform equipment and process characterizations and qualifications (IQ / OQ / PQ).

· Manage required builds for new product development in a pilot or production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues. · Comply with applicable FDA and international regulatory laws / standards.

· Perform other duties as assigned or required.

Requirement :

PREFERRED QUALIFICATIONS :

· Knowledge of processing materials associated with medical devices such as Polymers (nylons, polyethylene, polypropylene, PEEK, PTFE, FEP, etc.), and Metals (nitinol, platinum, stainless steel, etc.)

· Hands-on experience with processes associated with medical manufacturing such as shrinking (reflow), laser bonding, laser welding, thermal bonding, adhesive bonding, braiding, coil winding, hydrophilic coating, plasma treatment, cleaning processes, crimping, heat setting, electropolishing, swagging, etc.

· Experience with manufacturing line layout, capacity analysis, and line balancing.

· Process background (development, capability, optimization, validation) within a regulated industry.

· Proficient with development and qualification of fixtures / tooling / equipment (IQ / OQ / PQ, support, design).

· Experience working with outside OEM Suppliers in component development, and selection of equipment and processes.

o Experience being on project teams tasked with new product development and successful transfer into manufacturing.

· Experience with design and process FMECA, process validation, and process control.

o Knowledge of design for manufacturability and lean methodologies. HM's Top Needs :

1. Previous medical device experience

2. Hands-on experience in manufacturing (preferably medical device)

3. Process validation experience Education Required : Science / Engineering Degree : Sr (BS, MS) Years’ Experience Required : Sr (min 3-4 yrs)