Description As a senior medical device assembler, you will take on a critical leadership role in the assembly process, utilizing your extensive experience and technical expertise to ensure the production of high-quality medical devices that comply with industry regulations and standards. This position not only emphasizes your advanced assembly skills but also allows you to play a pivotal role in enhancing patient care through the delivery of safe and reliable medical devices. Principal Responsibilities • Oversee complex assembly operations, guiding the assembly team through intricate procedures while troubleshooting any issues that arise. • Maintain comprehensive documentation to support compliance with regulatory bodies. • Mentor and train new technicians, sharing your knowledge and fostering professional development within the team. • Lead assembly projects and initiatives. • Ensure compliance with regulatory standards (e.g., FDA). • Develop and improve assembly procedures and workflows. • Provide technical support and guidance to all assembly team members. Requirements • 5-10 years of experience in medical device assembly or a related manufacturing field is required. Supervisory or leadership experience is a plus. • Technical Proficiency: Strong skills in using assembly tools and equipment, familiarity with technical drawings, and proficiency in assembly processes. • Regulatory Knowledge: Understanding of FDA regulations, ISO standards, and Good Manufacturing Practices (GMP) related to medical devices. • Quality Control: Ability to adhere to quality control protocols and maintain meticulous documentation for compliance and traceability. • Problem-Solving Skills: Strong analytical skills for troubleshooting assembly issues and implementing solutions effectively. • Communication Skills: Good verbal and written communication skills for effective collaboration with team members and documentation of procedures. • Attention to Detail: High level of accuracy in following detailed instructions, with an emphasis on maintaining quality standards. • Adaptability: A Willingness to learn new technologies and adapting to new manufacturing practices will be necessary. • Teamwork: Strong ability to work collaboratively in a team setting and mentor junior assemblers when needed. Education Requirements High School Diploma or equivalent required. A college degree in a relevant field preferred. Equivalent experience may also be accepted. Supervisory Responsibility No supervisory responsibility. Working Conditions This job operates in manufacturing laboratory environments including ISO class 7 cleanrooms. Physical surroundings This role routinely uses standard office equipment such as computers, phones, and filing cabinets. PPE required when in controlled environment rooms. Physical Effort While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear. Travel Limited, local travel may be required. Other Requirements This position involves access to technology that is subject to U.S. export controls. Any job offer made will be contingent upon the applicant’s capacity to serve in compliance with U.S. export controls.