- Lead or support the execution of mechanical change requests involving existing hearing aid products and their assemblies, ensuring proper design control and approval processes.
- Design and update assembly tooling and fixtures using CAD systems, build and validate prototypes, specify suitable materials and finishes, and work with vendors to develop and qualify tools and processes.
- Develop and maintain mechanical assembly machines and fixtures for production and R&D, supporting electronics integration when needed, and analyze costs to optimize manufacturability.
- Plan and execute design verification testing on mechanical modifications to confirm meeting product requirements, support first article inspections, and aid in debugging prototypes and production units.
- Participate in design validation activities, risk assessments (DFMEA), and contribute to comprehensive documentation including CAD models, drawings, and engineering change orders compliant with the organization’s procedures.
- Act as a technical interface on project teams, coordinating with various departments and external suppliers, presenting design concepts and verification results, and providing guidance to support engineers and technicians.
- Support regulatory documentation efforts related to mechanical engineering changes.
- Additional duties as assigned to support team and company goals.
Required Qualifications
- Bachelor’s degree in Mechanical Engineering or a related field, or equivalent experience.
- Minimum 1+ years of relevant engineering experience in product development or manufacturing environments, preferably within the medical device or hearing aid sectors.
- Proficiency with MS Office suite and CAD tools (Pro-E/Creo preferred).
- Knowledge of manufacturing processes, materials, and injection molding.
- Familiarity with geometric dimensioning and tolerancing (GD&T) and statistical process control (SPC) is desirable.
- Strong analytical skills, attention to detail, and a quality-oriented mindset.
- Excellent written and verbal communication skills.
- Self-motivated, capable of working independently, managing multiple tasks, and collaborating effectively in a team.
Preferred Qualifications
- Experience with product development best practices such as Design for Manufacturing (DFM), Design of Experiments (DOE), DFMEA, and Lean Product Development.
- Intermediate understanding of acoustics and vibration analysis.
- Ability to perform complex engineering analysis and calculations.
- Proven ability to manage tasks from design to completion with minimal guidance.
- Experience working on mechanical designs for medical or similar regulated industries.
- Ability to stay current with emerging technologies and manufacturing trends
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.