TITLE: Process Development Engineer I (CAD)
DEPARTMENT: Advanced CAD Engineering
REPORTS TO: Senior Process Engineer
Position is responsible for original creation and development of patient-specific implant designs using image-derived anatomic information. This person works closely with the CAD Manufacturing, Advanced CAD Manufacturing, Research and Development and Software Engineering divisions to develop production processes and manage resources for the efficient automation of patient specific implants. Ensure consistent high quality of implant products and procedures through high attention to detail and diligence.
Essential Duties and Responsibilities:
1. Generate 3D and other post-processing images from diagnostic CT, MRI and other data sources using commercial and research software and computers.
2. Responsible for planning, developing, and managing CAD process development activities to ensure that process knowledge is transferred successfully from development to CAD production.
3. Develops process specifications and user requirements with respect to CAD production related software.
4. Maintain effective working relationships and communication with departmental and other
5. Execute paperwork and Information System functions as necessary for each patient implant.
6. Acknowledge and participate in research programs, quality assurance and quality improvement projects carried on in the company.
7. Work with the divisional leaders to improve the quality of data sets provided for processing.
8. Performs tasks under the company FDA and ISO-conforming quality system.
9. Train various personnel within the department.
10. Works with divisional and corporate staff to resolve more complex software or data issues related to implant design and production.
11. Daily work with the production and software teams and keeping detailed records and reports. These are used to highlight project status and to support ongoing production and
12. Evaluates new and existing design procedures, ensuring relevance, efficiency and quality of methods.
13. Oversees process improvement, CAD process validation and implementation efforts for CAD production.
14. Conducts and coordinates appropriate tests and collection of data related to production methods to ensure accuracy and quality.
15. Perform all other duties as directed or assigned.
1. Minimum of 3 year’s experience using 3D CAD modeling software.
2. Bachelor’s degree in engineering discipline.
3. Mechanical, Software or Biomedical engineering experience preferred.
4. Minimum of 1-2 years medical device experience.
Skills, Abilities, Competencies Required:
1. Must have interpersonal skills (verbal and written) sufficient to interact effectively with
customers and coworkers.
2. Willingness to work flexible hours as needed.
3. Must have the ability to adapt to changing pace within the department, with frequent interruptions.
4. Must demonstrate flexibility and willingness to adapt to diverse roles as a member of the corporate team.
5. Must be aware of hazards within the company; adhere to safety standards established by FDA and other regulatory agencies (large magnetic field, ionizing radiation, universal precautions, etc.).
6. Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, etc.).
7. Willingness to learn needed skills on the job in order to enhance performance.
8. Understands completely various production and quality processes.
9. Be proactive and anticipate tasks required to complete assignments
10. Be able to communicate thoughts and ideas fluently both verbally and in writing