- Company Name
- Shoolin Inc
- Job Title
- Manufacturing Engineer
- Job Description
-
**Job Title**
Manufacturing Engineer
**Role Summary**
Design, build, and validate manual and semi‑automated assembly processes for early‑stage medical device products. Own the transition from R&D prototypes to production‑ready manufacturing, ensuring repeatable, ship‑ready operations through fixtures, tooling, and process documentation.
**Expectations**
Hands‑on experience in low‑automation manufacturing environments. Proven ability to partner with R&D during new product introduction. Strong foundation in process ownership, validation, and continuous improvement. Knowledge of PFMEA, control plans, and work instructions. Ability to design, build, and debug custom equipment and fixtures.
**Key Responsibilities**
- Define assembly sequences, interfaces, and inspection criteria in collaboration with R&D.
- Design, construct, and optimize manual/semi‑manual assembly stations, fixtures, tooling, gauges, and nests.
- Own and validate specific equipment or processes from development through execution.
- Conduct equipment build, debugging, testing, and iterative improvement.
- Perform time studies, process optimization, and line‑balancing activities.
- Develop and maintain manufacturing documentation (process specs, work instructions, control plans).
- Support transition from pilot to scaled manufacturing, ensuring quality standards are met.
**Required Skills**
- Hands‑on assembly process development for manual or low‑automation medical devices.
- Mechanical, electrical, and functional inspection/testing experience.
- Proficiency in PFMEA, control plans, and work instruction creation.
- Experience with custom equipment, fixture, and tooling development.
- Strong analytical and problem‑solving abilities.
- Excellent communication and cross‑functional collaboration.
**Required Education & Certifications**
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or related field.
- Certification in Lean Manufacturing, Six Sigma, or equivalent preferred.