This exciting position is for the Engineer who wants to broaden their skills and take on diverse responsibilities as part of a fast-growing advanced medical device company that will impact millions of lives. In this capacity, the role of the Manufacturing Engineer II is to work closely with R&D, Quality, and Operations in the development/improvement of new/existing products and the processes necessary to produce these products in a manufacturing environment. This role will also manage development builds, develop new manufacturing processes, implement and qualify production equipment and methods, generate testing protocols and reports, and work with minimal direction. The job requires excellent communication skills, and comfort working in a fast-paced, rapidly growing startup environment. If you are looking for a challenge and want to make a meaningful contribution, then this is the perfect role for you.
- Manage required builds for existing product development improvements/new product development in a pilot or in a production setting, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, and troubleshooting assembly issues.
- Provide manufacturing capacity analysis of existing product lines.
- Lead the development of highly capable manufacturing processes for new/existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations.
- Develop and coordinate the execution of process characterization and validation plans.
- Comply with applicable FDA and international regulatory laws/standards.
- Lead/support production line in non-conformance investigations and dispositions.
- Development of manufacturing documentation (MP, IP, BOM).
- Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
- Design and implement custom equipment/ tools, fixtures and/or off the shelf equipment/ tools, fixtures for highly capable manufacturing processes for new and existing products through frequent interaction with R&D, Manufacturing Engineering, Quality Engineering, and Operations.
- Work with outside OEM Suppliers, internal/external machine shops and or other departments/groups.
- Application of statistical and analytical methods such as SPC, SQC, and DOE.
- Participation on project teams tasked with new process/product development and the successful transfer into manufacturing.
- Process background (development, capability, optimization, validation) within a regulated industry.
- Other duties as assigned or required.
SKILLS & QUALIFICATIONS
- Bachelor's Degree or equivalent in Engineering required – Mechanical, Industrial, Manufacturing, Materials.
- Minimum of 5-7 years experience OR Master's Degree + internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education required.
- Good computer skills in usage of MS Office Suite
- Good documentation, communication and interpersonal relationship skills including negotiating and supplier relationship skills.
- Basic understanding of statistical techniques.
- Previous experience working with lab/industrial equipment required.
- Working knowledge of LEAN and SIX Sigma methodologies.
- Ability to learn & teach new technology and methods.
- AutoCad, Solidworks, 3matic experience preferred
- Knowledge in materials associated with medical devices such as polymers (nylons, polyethylene, polypropylene, PEEK, Pebax, PTFE, FEP, polycarbonate, etc.) metals (stainless steel, aluminum, nitinol, platinum etc.), ceramic, fiber, composites, etc. preferred
- Knowledge in processes associated with medical manufacturing such as shrinking (reflow), RF welding, laser bonding, welding & cutting, thermal bonding, adhesive bonding, braiding, coil winding, insert molding, hydrophilic coating, plasma treatment, cleaning processes, cutting/skiving/slitting, crimping, etc.
- Proficient in design and process FMECA/FMEA/Hazards Analysis/Risk Analysis, Process Validation and variability reduction applications.
- Proficiency with program languages such as (g-code, C++, VB etc.) but not required.
BENEFITS & PERKS
- Salary depending on experience
- Competitive salary and stock options
- Medical, dental, vision and disability
- Flexible work schedules
ABOUT SWIFT HEALTH SYSTEMS INC.
Located in the hotbed of innovation near Irvine's University Research Park, we are a fast-paced Silicon Valley backed dental device company. If you are looking for a work environment with a positive culture that will empower and challenge you, we encourage you to submit your resume for review.