The R&D/Product Development Technicians are responsible for supporting concept selection, design feasibility, design verification, and process validation as defined by the quality system. R&D/Product Development Technicians teams will develop processes and continue to analyze process capability until the process has been proven to be stable and reliable. After design and process stability has been verified, R&D/Product Development Technicians will engage in production transfer activities. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).
• Support Engineering in providing the customer with an Exceptional Customer Experience
• The technician must work proficiently to deliver on or ahead of schedule.
• Assist the engineering team with device design and development including: rapidly prototyping designs, troubleshooting failures, proposing and evaluating design and process improvements
• Assemble Class II and III prototype components, subassemblies and assemblies
• Works from product specifications and written/verbal instructions.
• Develop and execute tests for new and improved design concepts processes, procedures, and test methods.
• Record build data in laboratory notebooks
• Develop, design and implement efficient and useful fixtures and tooling for manufacturing and process improvements of new or modified products / processes
• Review, develop, and improve manufacturing instructions
• AA Degree or equivalent work experience in related discipline and 3 years of related experience in the medical device industry
• Working knowledge of engineering principles and ability to read and comprehend work instructions, schematics and design documentation
• Experience with welding, braiding, coiling, heat shaping, hot air bonding, swaging and fusing is preferred
• Critical thinking, troubleshooting and problem solving ability
• Ability to work independently as well as part of a team
• Proficiency with Microsoft desktop environment: Windows, Word, Excel, and Outlook
• Proficiency with SolidWorks, and Minitab is a plus
• Good written and verbal communication skills
• Basic anatomy and product use is not required but encouraged
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at firstname.lastname@example.org or 844-463-6178.