Summary: Silk Road Medical is looking for a Senior Manufacturing Engineer who will develop and improve processes and equipment to facilitate the manufacturing of new, redesigned and current products to meet established specifications. This role, as a member of the Operations Department, is responsible for supporting all aspects of Manufacturing Operations.
- Evaluate and develop innovative solutions to complex product and production problems through identification and implementation of advanced manufacturing processes. This will include conducting process analysis, applying knowledge of product design, fabrication, assembly, tooling, automation and materials.
- Support continuous improvement and design enhancement of current products to improve quality and cost.
- Ensure proper documentation is completed to meet quality systems requirements.
- Provide Design for Manufacturability (DFM) input and contribute to overall design project working team.
- Support the ISO, EN, and MDD certification process and compliance to FDA regulations by ensuring compliance to all applicable policies, procedures and guidance documents during the discharge of assigned tasks and duties.
- Analyze and plan work force utilization, space requirements, workflow, and designs layout of equipment and workspace for maximum efficiency. Evaluate line efficiency, cycle time, and TAKT time.
- Define Equipment Qualification and Process Validation Protocols (IQ, OQ, PQ) and provide training for Production Team Members on Standard Operation Procedures and Work Instructions for new processes and equipment.
- Participate in the development of corrective and preventative action plans.
- Execute engineering and quality methods analysis including FEA, Tolerance Analysis, DOE, SPC, FMEA, Pareto Charts, Process Capability, etc.
- Support other Company functions as needed, including R&D, Quality, Clinical and Regulatory.
- Other duties may be assigned
Minimum Qualifications, Experience and Skills Required:
- 6 to 8 years of Manufacturing Engineering experience with process design, development and deployment.
- Bachelor’s degree in Engineering: Mechanical, Industrial, Manufacturing and Process disciplines or equivalent will be considered.
- Requires working knowledge in DFM, Lean Six Sigma methodologies, as well as DOE and Statistical Process Control.
- Experience solving problems that include addressing a variety of variables in pressure situations.
- Must be self-motivated, highly organized, and resourceful in solving manufacturing issues.
- Possess a well-developed team orientation with critical thinking and problem solving/analytical skills.
- Prior experience with catheter manufacturing desired.
Interested candidates should submit their resume to firstname.lastname@example.org.