The Design Engineer designs and develops medical device products and components for products in compliance with applicable quality system procedures and regulations.
Travel Requirements:
This position may require less than 20% travel.
Job Responsibilities:
CAD/CAM design and development in a NX environment.
Analyze and assess performance of design results on a surgical robotic platform.
Applies broad based skills to design and develop biomedical products, including hardware, software, and design data components.
Applies knowledge of regulatory processes to ensure compliance with existing procedures and to drive procedural improvements.
Follow rigorous design control methodology and write concise requirements specifications, architecture specifications, and design description, verification plans, and test cases.
Interfaces with external partners and clinicians to identify and implement product support requirements, and to manage related verification, validation, and release activities.
Provides planning and status information to project manager.
Bachelor’s degree in mechanical engineering or related field.
At least 2 years’ experience in medical device industry.
Experience managing design controls efforts and preparing documents for 510(k) submissions.
Experience establishing test plans and procedures, and performing hazard and traceability analysis.
CAD/CAM experience. NX experience strongly preferred.
Biomechanics and implant design experience preferred.
Algorithm development and Software background a plus (.Net experience a plus but not required.)
Knowledge of applicable Quality System Standards, including FDA 21 CFR 820, ISO 13485 and ISO 14971.
Strong academic records.
Excellent communication and documentation skills.
Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Attendance and Punctuality are essential function of the position.
Think Surgical Inc,.offers a fast-paced work environment, very competitive compensation, medical and 401K retirement plan benefits.
We are an equal opportunity employer and encourage diversity.
