Design Engineer

The Design Engineer will be responsible for the development of innovative medical devices, including design, prototyping, technical analyses, and testing. This role collaborates with cross-functional teams to ensure designs meet user needs, comply with quality standards, and align with manufacturability requirements. The position involves direct communication with customers and manufacturing partners and requires occasional travel (10%+). The Design Engineer will also support regulatory filings for combination products.

Key Responsibilities

Execute design and development activities for drug delivery devices in alignment with design controls.

Plan and conduct testing for design characterization, feasibility, and verification.

Perform technical analyses, including statistical analysis and tolerance analysis.

Lead root cause investigations and implement corrective actions.

Support commercialization and scale-up of new products.

Qualifications

Required :

Bachelor’s degree in Mechanical Engineering or Biomedical Engineering.

2–4 years of experience in mechanical or biomedical device design.

Proficiency in mechanical design software (SolidWorks preferred).

Strong technical writing and documentation skills.

Proficiency in Microsoft Office Suite.

Strong communication skills, both written and verbal.

Preferred :

Experience with statistical analysis, tolerance analysis, and technical modeling.

Knowledge of medical device regulations and standards (21 CFR Part 820, ISO 13485, ISO 11608, ISO 14971).

Understanding of manufacturing processes, particularly injection molding.

Experience with Design for Manufacturing and Assembly (DFMA).

Knowledge of risk management tools, including FMEA.

Experience with Finite Element Analysis (FEA).

Root cause analysis expertise.

Physical Requirements

Regularly required to sit, talk, and hear.

Occasionally required to stand, walk, handle objects, and reach with hands and arms.

Must be able to lift and / or move up to 10 pounds.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.