Job Title

Manufacturing Engineer I at Nissha Medical Technologies in Sandpoint, Idaho, United States Job Description JOB DESCRIPTION Nissha Medical Technologies is looking for a Manufacturing Engineer I to join our Sandpoint, ID. Team The Manufacturing Engineer I supports the production and quality teams by developing, maintaining, and improving manufacturing processes and documentation within a regulated medical device manufacturing environment. This role is responsible for authoring and executing equipment and process validations (IQ/OQ/PQ), developing and supporting risk management tools (FMEAs), and participating in cross-functional projects that improve quality, efficiency, and safety. While recent graduates will be considered, preference will be given to candidates with previous experience in the medical device or other FDA-regulated industries. ESSENTIAL DUTIES AND RESPONSIBILITIES (other duties may be assigned) Documentation & Change Control 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 Validation & Risk Management 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 Process Development & Improvement 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 Cross-Functional Collaboration 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 MINIMUM QUALIFICATIONS Qualifications & Experience 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 Education Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or a related technical field Equivalent combination of education and relevant experience in manufacturing engineering may be considered Knowledge, Skills & Abilities 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 Experience with Lean Manufacturing tools (5S, Kaizen, VSM) preferred Familiarity with statistical tools (e.g., Minitab, Excel) and ERP/MRP systems is a plus 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 Physical Requirements This position requires the physical ability to: Frequently remain in a stationary position for long periods of time Occasionally move between buildings and offices Frequently operate a computer and other office equipment Constantly and successfully communicate with employees, managers, and members of the public, in person and on the phone, regarding sensitive matters, discern and convey emotion, and understand and exchange accurate information Occasionally lift and move up to 45 pounds Constantly recognize detail, inspect documents and product, observe behavior, and recognize potential violations or hazards Occasionally ascend/descend stairs to access work areas Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Nissha Medical Technologies is committed to fair, competitive, and market-informed pay for our employees. The pay for this position is $60,000-$75,000/ year paid on a bi-weekly basis. The successful candidate's particular combination of knowledge, skills, and experience will inform their specific compensation. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Nissha Medical Technologies will provide reasonable accommodations for qualified individuals with disabilities. If you need assistance with completing the online application process, please call Human Resources at (719) 426-9074. 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