Job Description
SUMMARY:
We are seeking a Product Development Engineer to become an immediate and valuable contributor to the Engineering team. The Product Development Engineer is integral to the design, development, and industrialization of our diagnostic products.
RESPONSIBILITIES:
- Design and develop diagnostic devices and consumables
- Continually optimize manufacturing procedures to produce less expensive, higher quality diagnostic devices and consumables
- Develop and perform test procedures to verify and validate product quality and efficacy
- Document all testing and development activities and then complete design and process change documentation as required
- Assist in the completion of new and existing product design verifications and validations
- Complete design drawings and models in Solidworks (or equivalent) and create prototypes to progress the development through its design stages
- Assist in training personnel to processes associated with design and development of diagnostic and accessories
- Develop efficient (i.e. cost, material, time, etc.), user-friendly manufacturing processes
- Assist in the resolution, documentation, and customer responses of product complaints
- Coordinate and assist in corrective and preventative action activities and solutions
- Comply with appropriate regulatory agencies (i.e. GMP, ISO, FDA, etc.) and associated quality systems
- Communicate with strategic vendors and suppliers
SKILLS:
- Hands-on experience designing, building, assembling, and troubleshooting prototypes
- Experience in regulated industry; Medical Device or Diagnostic preferred
- Good written and verbal communication skills
- Project management
- Self-starter
- Strong organizational skills
- Excellent problem-solving skills
REQUIREMENTS:
- BS/BA in applicable field of study, preferabbly engineering (Mechanical or BioMedical Engineering)
- 2 - 10+ years of experienc; salary will be commensurate with skills and experience