Manufacturing Engineer I
Not Disclosed•Full-TimeOn-site
location_onChevron, Cedar Street, Sandpoint, Bonner County, Idaho, 83864, United States
About the Role
Nissha Medical Technologies is seeking a Manufacturing Engineer I to join our dedicated team in Sandpoint, ID. In this role, you will support production and quality teams by developing, maintaining, and improving manufacturing processes and documentation within a regulated medical device environment. You will be responsible for authoring and executing equipment and process validations (IQ/OQ/PQ), developing risk management tools like FMEAs, and participating in cross-functional projects that drive quality, efficiency, and safety.
While we welcome recent graduates, we prioritize candidates with previous experience in the medical device or other FDA-regulated industries. This position offers a unique opportunity to apply Lean Manufacturing principles and collaborate with Engineering, Quality, and Production teams to resolve technical issues and support operational goals.
Hiring Process
If you need assistance with completing the online application process, please contact Human Resources at (719) 426-9074.
Equal Opportunity
Nissha Medical Technologies is an Equal Opportunity Employer. We consider 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. We are committed to providing reasonable accommodations for qualified individuals with disabilities to perform the essential functions of the job.
Work location
Work model: On-site
Chevron, Cedar Street, Sandpoint, Bonner County, Idaho, 83864, United States
Sandpoint, Idaho
Key Responsibilities
- check_circleDevelop and execute equipment and process validation protocols following IQ/OQ/PQ methodology
- check_circleAnalyze validation results and prepare comprehensive reports meeting regulatory standards
- check_circleCo-develop Process and Design FMEAs in coordination with cross-functional teams
- check_circleAssist in the design and implementation of manufacturing equipment, tooling, and fixtures
- check_circleConduct time studies and workflow analyses to support production efficiency
- check_circleApply Lean Manufacturing principles to improve quality, reduce cost, and increase throughput
- check_circleEnsure compliance with ISO 13485 and FDA 21 CFR Part 820 regulations
- check_circleCreate and maintain technical documentation including engineering change orders, drawings, and work instructions
Requirements
- verifiedBachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or related technical field
- verifiedProficiency with SolidWorks or similar 3D CAD software
- verifiedFamiliarity with IQ/OQ/PQ validation practices
- verifiedUnderstanding of FMEA methodology and risk management
- verifiedExperience with Lean Manufacturing tools (5S, Kaizen, VSM) preferred
- verifiedFamiliarity with statistical tools (e.g., Minitab, Excel) and ERP/MRP systems a plus
- verifiedPrior experience in FDA-regulated environment strongly preferred
Nice to Have
Prior experience in an FDA-regulated environment (medical device, pharmaceutical, diagnostics, etc.). Experience with Lean Manufacturing tools (5S, Kaizen, VSM). Familiarity with statistical tools (e.g., Minitab, Excel) and ERP/MRP systems.
Similar Job Opportunities
Solidworks Designer
Gabletek Robotics and Controls Solutions • Nashville, Tennessee
Not Disclosedarrow_forward
On-Site Product Engineer
Armstrong International – Intelligent Solutions in Steam, Air and Hot Water • Three Rivers, Michigan
Not Disclosedarrow_forward
Design Engineer2
Curry Supply Company • Frankstown Township, Pennsylvania
$78k-88karrow_forward
Skills, education and keywords
Skills: Solidworks, Iq/oq/pq, Fmea, Lean Manufacturing, 5S, Kaizen, Value Stream Mapping, Iso 13485, Fda 21 CFR Part 820, Minitab.
Education: Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or related field.
Frequently asked questions about Manufacturing Engineer I at Nissha Medical Technologies
What does a Manufacturing Engineer I at Nissha Medical Technologies do?expand_more
In this Manufacturing Engineer I at Nissha Medical Technologies role, you will develop and execute equipment and process validation protocols following iq/oq/pq methodology; analyze validation results and prepare comprehensive reports meeting regulatory standards; co-develop process and design fmeas in coordination with cross-functional teams; and assist in the design and implementation of manufacturing equipment, tooling, and fixtures.
What are the requirements for this Manufacturing Engineer I role?expand_more
To qualify for the Manufacturing Engineer I at Nissha Medical Technologies position, applicants should have: Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or related technical field; Proficiency with SolidWorks or similar 3D CAD software; Familiarity with IQ/OQ/PQ validation practices; Understanding of FMEA methodology and risk management; Experience with Lean Manufacturing tools (5S, Kaizen, VSM) preferred; and Familiarity with statistical tools (e.g., Minitab, Excel) and ERP/MRP systems a plus.
Where is the Manufacturing Engineer I role at Nissha Medical Technologies located?expand_more
Manufacturing Engineer I at Nissha Medical Technologies is based in Chevron, Cedar Street, Sandpoint, Bonner County, Idaho, 83864, United States. This is a on-site role.
Is this Manufacturing Engineer I job remote, hybrid, or on-site?expand_more
Nissha Medical Technologies has listed this Manufacturing Engineer I role as on-site.
How much experience is required for this Manufacturing Engineer I role?expand_more
Candidates for Manufacturing Engineer I at Nissha Medical Technologies should have entry level.
What skills do you need for the Manufacturing Engineer I role at Nissha Medical Technologies?expand_more
Key skills for Manufacturing Engineer I at Nissha Medical Technologies include Solidworks; Iq/oq/pq; Fmea; Lean Manufacturing; 5S; Kaizen; Value Stream Mapping; and Iso 13485.
What education is required for Manufacturing Engineer I at Nissha Medical Technologies?expand_more
Educational requirements for this role: Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or related field.
What category does the Manufacturing Engineer I role belong to?expand_more
Manufacturing Engineer I at Nissha Medical Technologies is part of the engineering job category on Recrutus.