Manufacturing Engineer I at Nissha… · Sandpoint

Summary: Nissha Medical Technologies is looking for a Manufacturing Engineer I to join their team in Sandpoint, ID. This role supports production and quality teams by developing, maintaining, and improving manufacturing processes within a regulated medical device environment, focusing on equipment and process validations and risk management tools. Responsibilities: - Create and maintain technical documentation including engineering change orders (ECOs), drawings, work instructions, and procedures in accordance with internal document control processes - Support change control efforts related to products, processes, and customer requirements - Develop and execute equipment and process validation protocols following IQ/OQ/PQ methodology - Analyze and interpret validation results; prepare comprehensive reports that meet internal and regulatory standards - Support and co-develop Process and Design FMEAs in coordination with cross-functional teams - Assist in the design and implementation of manufacturing equipment, tooling, and fixtures - Conduct time studies and workflow analyses to support production efficiency - Apply Lean Manufacturing principles (e.g., 5S, Kaizen, Value Stream Mapping) to improve quality, reduce cost, and increase throughput - Collaborate with production teams to identify, evaluate, and implement process improvements - Participate in cross-functional meetings with Engineering, Quality, and Production to resolve technical issues and support operational goals - Promote a culture of safety and continuous improvement within the engineering function - Ensure compliance with applicable regulations, including ISO 13485 and FDA 21 CFR Part 820 Required Qualifications: - Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or a related technical field - Proficiency with SolidWorks or similar 3D CAD software required - Familiarity with validation practices including IQ/OQ/PQ and supporting documentation - Understanding of FMEA methodology and risk management principles - Strong interpersonal and teamwork skills with ability to work across departments - Excellent communication skills with the ability to clearly document and explain complex technical issues - Detail-oriented with strong organizational and time management skills - Ability to prioritize and manage multiple projects simultaneously - Self-motivated and accountable; able to follow direction and work independently when needed - Prior experience in an FDA-regulated environment strongly preferred (medical device, pharmaceutical, diagnostics, etc.) - Recent graduates with relevant internship, co-op, or project-based experience in a regulated environment are encouraged to apply Preferred Qualifications: - Experience with Lean Manufacturing tools (5S, Kaizen, VSM) preferred - Familiarity with statistical tools (e.g., Minitab, Excel) and ERP/MRP systems is a plus Required Skills: FDA regulations, Process validation, Lean Manufacturing Important Skills: SolidWorks, FMEA methodology, Statistical tools Nice-to-Have Skills: Self-motivated