Manufacturing Engineer I
About The Position
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.
Requirements
- 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
- 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
- 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
Nice To Haves
- Experience with Lean Manufacturing tools (5S, Kaizen, VSM) preferred
- Familiarity with statistical tools (e.g., Minitab, Excel) and ERP/MRP systems is a plus
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
