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 with the mechanical design team in designing automated instruments to analyze and process biological samples.
The ideal candidate possesses deep expertise in Design for Manufacturability and Assembly (DFMA), hands-on experience with injection molding process development, and a strong understanding of FDA regulatory and quality standards (ISO 13485 / 21 CFR Part 820).
2. Duties and responsibilities (Essential Functions)
Product Design & Development
- Lead the mechanical design and architecture of complex medical devices, assemblies, and high-volume plastic consumables.
- Utilize advanced 3D CAD modeling software (SolidWorks) to design injection-molded components, enclosures, microfluidics, or disposable components.
- Apply strict Design for Manufacturability (DFM) and Design for Assembly (DFA) principles tailored specifically for plastic injection molding.
Tooling & Injection Molding Process Development
- Collaborate closely with toolmakers, molders, and suppliers to define mold and part specifications
- Oversee tool builds, T1 samples, and tool modification iterations through final approval.
- Support injection molding process development, including Scientific Molding principles (RJG principles preferred), DOE (Design of Experiments), and process window optimization.
- Lead Design for Moldability reviews and perform root-cause analysis on plastic component defects.
Quality, Regulatory & Verification
- Execute design controls according to ISO 13485 and FDA 21 CFR 820.30.
- Develop Design History File (DHF) documentation, including Design Inputs, Design Outputs, Risk Assessments (dFMEA/pFMEA), and Traceability Matrices.
- Plan, author, and execute Design Verification and Validation (V&V) protocols and reports (IQ/OQ/PQ for tooling and assembly processes).
- Perform mechanical bench testing, protocol generation, test fixture creation, and statistical data analysis (Minitab).
3. Qualifications (Education, Experience, Skills, Certifications, etc.)
Education:
Bachelor’s Degree in Mechanical Engineering or closely related field
Preferred Master’s Degree in Engineering
Preferred 2+ years of design experience
Additional desired qualifications -
- Certification in Scientific Molding or Plastics Engineering.
- Experience with high-volume consumable automation and assembly processes (ultrasonic welding, solvent bonding, laser welding).
- Familiarity with medical-grade resins and USP Class VI materials.
Note: Assignment or promotion to any level is not guaranteed nor automatic.
Skills:
- CAD design of Injection molding and machining part design
- 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.
Pay: From $80,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
