Design Engineer

The Design Engineer is responsible for the design and support of OPM’s OsteoFab® products, primarily patient specific cranial and facial implants and OsteoFab Custom devices, and the sustainability of existing products and processes., * Interprets and assesses patient scan data using DICOM segmentation and modeling software.

• Generates patient specific implants per OPM’s internal procedures based on patient data and design inputs from surgeons and sales reps.
• Translates design ideas into prototypes using CAD and/or modeling and simulation software.
• Proposes designs and features for a specific indication through scientific research.
• Troubleshoots and evaluates designs through FEA and modifies designs as needed.
• Inspects prototypes and collects data to optimize designs.
• Efficiently communicates case and design information directly with internal and external members of the design team.
• Participates in, and facilitates when needed, web meetings with medical professionals and surgeons to review implant design.
• Coordinates review of implant designs and transfer to production.
• Supports complaint and nonconformance investigations, including correction/containment, root cause analysis, risk assessment, and corrective/preventive actions steps, in collaboration with Engineering & Compliance.
• Provides design, engineering, and analysis support to other engineers and designers in the development of medical devices.
• Initiates design changes relative to manufacturability while maintaining critical features for in-house manufacturing or vendors.
• Seeks continuous development and training on design and manufacturing process improvement.
• Reviews LS design files against design rules and build preps.
• Maintains Quality paperwork by completing forms, documents, and quality measurements per production run, whenever appropriate.
• Performs special projects and assignments as directed by supervisor.

Secondary Job Functions:

• Works in an ISO:13485 quality-controlled environment.
• Assists in the development and continuous improvement of Laser Sintering process in order to achieve customer design requests within specified parameters.
• Assists in the development processes for Manufacturing, Quality Control, Regulatory, and Planning for assigned projects.
• Participates on cross-functional project teams.
• May assist in developing quality control procedures and inspection methods.

Do you have experience in Requirements specification?, * Bachelor’s Degree in Engineering or science discipline; Biomedical Engineering (preferred).

• 1-5 years designing cranial and facial implants (preferred).
• Knowledge of the CAD software, Materialise software suite (3-Matic and Mimics) (preferred).
• CAD/CAM design and development experience (preferred).
• Familiarity with human anatomy and physiology, specifically craniomaxillofacial regions (preferred).
• Knowledge in the use and interpretation of geometric dimensioning and tolerancing (preferred).
• Prior experience in a manufacturing environment, including knowledge of manufacturing methods, predominantly with plastics (preferred).
• Experience communicating with professionals in the medical field (specifically surgeons) (preferred).
• Strong verbal and written communication skills; comfortable presenting to senior management.
• Ability to translate and/or derive customer requirements to engineering specifications.

Pulled from the full job description

• Parental leave
• 401(k)
• Health insurance
• Paid time off
• Vision insurance
• Health savings account
• Dental insurance, * 401(k)
• Dental insurance
• Disability insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance