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Manufacturing Engineer I

Nissha Medical Technologies

Sandpoint, Idaho

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JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, CAD (Computer-Aided Design) Software, Change Control, Code of Federal Regulations, Communication Skills, Continuous Improvement, Cost Control, Cross-Functional, Detail Oriented, Document Control, Documentation, ERP (Enterprise Resource Planning), Engineering Change Order, Equipment Validation, Establish Priorities, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), ISO (International Organization for Standardization), Industrial Engineering, Interpersonal Skills, Lean Manufacturing, Maintain Compliance, Manufacturing, Manufacturing Engineering, Manufacturing Equipment, Manufacturing/Industrial Processes, Medical Equipment, Minitab, Multitasking, Office Equipment, Operational Support, Organizational Skills, Physical Demands, Problem Solving Skills, Process Development, Process Improvement, Process Validation, Product Documentation, Production Support, Project/Program Management, Quality Management, Regulations, Regulatory Compliance, Reporting Skills, Risk Management, Safety/Work Safety, SolidWorks, Team Player, Technical Support, Technical Writing, Time Management, Tool and Die Manufacturing, Validation Plan, Value Stream Mapping, Workflow Analysis, eCos
LOCATION
Sandpoint, Idaho
POSTED
7 days ago
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 th

About the Company

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Nissha Medical Technologies

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