What are the responsibilities and job description for the Senior Manufacturing Engineer position at Codiagnostics?
1. Job purpose
Co-Diagnostics Inc, (Co-Dx) is a Salt Lake City molecular diagnostics company committed to finding innovative diagnostic solutions to global health problems as we develop an at-home and point-of-care PCR test platform to detect viruses and other pathogens. The candidate will work within the manufacturing engineering team in developing, transferring, and monitoring production manufacturing lines.
2. Duties and responsibilities (Essential Functions)
• Collaborate with product engineering, scientific, quality, and manufacturing teams to transfer
products to manufacturing, set up and qualify new production lines, and coordinate with joint
ventures to transfer products and process to new manufacturing facilities.
• Apply lean manufacturing principles to standardize processes, remove inefficiencies, and
establish KPI’s to continuous monitor and improve the manufacturing process.
• Create process flows, work instruction documents, qualification protocols and reports.
• Participate in design reviews and technical reviews for products, equipment, and processes
throughout the product development process.
• Job site and regular attendance is required.
3. Qualifications (Education, Experience, Skills, Certifications, etc.)
Education:
• Bachelor’s Degree in Mechanical Engineering or closely related field
• 5 years of medical device manufacturing experience
Note: Assignment or promotion to any level is not guaranteed nor automatic.
Skills:
• Lean manufacturing principles
• Knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485)
• Experience with design control processes, risk management, and verification/validation activities
• Excellent communication and collaboration skills
• Ability to work independently and prioritize effectively in a fast-paced environment
4. Working conditions
• May work a variety of shifts that include a traditional workday (8:00 am to 5:00 pm, etc.), a 9/8/80
schedule with every other Friday off, or other shifts as may be assigned.
• Remote work is not available for this role.
5. Physical requirements
• This job requires long periods of sitting, standing, and walking.
• There will be stooping, bending, and twisting.
• Must be able to lift 10-20 pounds on a regular basis.
• Fine motor coordination with hand and finger dexterity.
• Good visual acuity including color perception.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or
responsibilities that are required of the employee. Duties, responsibilities, and activities may change,
or new ones may be assigned at any time with or without notice.
Our EEO Policy
Co-Diagnostics is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.
Co-Diagnostics participates in E-Verify. No immigration-related sponsorships are available.