Test Lab Manager

Managing a medical device mechanical testing laboratory Planning, execution, and documentation of mechanical (static, dynamic) testing Performing and/or scheduling equipment maintenance and repair. Supporting regulatory requirements Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the Quality Manual. The employee must at all times act and conduct company business in an honest, ethical, and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code, and all applicable laws and regulations, whether national, regional, state, or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code, or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations. Direct daily mechanical testing lab functions, including test execution and reporting. Collaborate with individual test requestors and project management on test scheduling across multiple projects. Manage equipment, including calibration, maintenance, and overall resourcing. In the event of potential non-compliance with applicable standards or regulations (e.g., FDA QSRs, ISO 13485, or ISO 14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above. The Test Lab Manager must at all times act and conduct company business in an honest, ethical, and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code, and all applicable laws and regulations, whether national, regional, state, or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code, or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations. Support our Quality System Requirements and Qualifications BS in an engineering discipline (Mechanical engineering preferred) 5+ years of hands-on experience with mechanical testing equipment (e.g., Instron, MTS). Proficiency in designing test fixtures and handling fabrication. Experience performing preventative maintenance and repair. Familiarity with testing to established ASTM and ISO standards, including static and dynamic testing. Preference for orthopedics and/or spine. Meticulous eye for detail and is process-oriented with traceable documentation practices to ensure compliance and repeatable results. Good communication/writing skills to effectively interact with co-workers. Proficiency with Microsoft Office tools (Outlook, Word, Excel). A commitment to safe equipment usage (e.g., PPE, guarding) The ability to work with colleagues to foster technical growth A passion for supporting an emerging company and sustaining high growth through engineering support. Be a proactive person who attacks problems, displaying initiative and perseverance in order to bring about meaningful change, and to be open and responsive to new ideas. Be known as a person who has high integrity, sound character, a tremendous work ethic, and the passion to succeed. Knowledge and familiarity with applicable regulations/standards (e.g., ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required to perform the job function is a plus. Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Test Lab Manager Direct Hire Full-Time Role Pay Rate: $63 - $70 per hour Location: Santa Clara, CA - Onsite Role Duties and Responsibilities Managing a medical device mechanical testing laboratory Planning, execution, and documentation of mechanical (static, dynamic) testing Performing and/or scheduling equipment maintenance and repair. Supporting regulatory requirements Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the Quality Manual. The employee must at all times act and conduct company business in an honest, ethical, and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code, and all applicable laws and regulations, whether national, regional, state, or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code, or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retirement in connection with making good faith reports of suspected violations. Direct daily mechanical testing lab functions, including test execution and reporting. Collaborate with individual test requestors and project management on test scheduling across multiple projects. Manage equipment, including calibration, maintenance, and overall resourcing. In the event of potential non-compliance with applicable standards or regulations (e.g., FDA QSRs, ISO 13485, or ISO 14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above. The Test Lab Manager must at all times act and conduct company business in an honest, ethical, and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code, and all applicable laws and regulations, whether national, regional, state, or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code, or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations. Support our Quality System Requirements and Qualifications BS in an engineering discipline (Mechanical engineering preferred) 5+ years of hands-on experience with mechanical testing equipment (e.g., Instron, MTS). Proficiency in designing test fixtures and handling fabrication. Experience performing preventative maintenance and repair. Familiarity with testing to established ASTM and ISO standards, including static and dynamic testing. Preference for orthopedics and/or spine. Meticulous eye for detail and is process-oriented with traceable documentation practices to ensure compliance and repeatable results. Good communication/writing skills to effectively interact with co-workers. Proficiency with Microsoft Office tools (Outlook, Word, Excel). A commitment to safe equipment usage (e.g., PPE, guarding) The ability to work with colleagues to foster technical growth A passion for supporting an emerging company and sustaining high growth through engineering support. Be a proactive person who attacks problems, displaying initiative and perseverance in order to bring about meaningful change, and to be open and responsive to new ideas. Be known as a person who has high integrity, sound character, a tremendous work ethic, and the passion to succeed. Knowledge and familiarity with applicable regulations/standards (e.g., ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required to perform the job function is a plus. Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Desired Skills and Experience Medical device testing laboratory management, mechanical engineering, 5+ years of mechanical testing experience, static and dynamic testing, Instron, MTS, test planning and execution, test scheduling across multiple projects, test fixture design and fabrication, equipment calibration, preventive maintenance and repair, resource allocation, ASTM and ISO testing standards, orthopedic and spine testing, traceable documentation and reporting, data integrity and repeatability, quality management systems, regulatory compliance, ISO 13485, FDA 21 CFR 820/QSR, EU MDR 2017/745, ISO 14971, noncompliance identification and escalation, AdvaMed Code compliance, laboratory safety and PPE, equipment guarding, Microsoft Outlook, Word and Excel, written and verbal communication, cross-functional collaboration, technical mentorship, attention to detail, process discipline, proactive problem-solving, initiative and perseverance, adaptability, integrity and strong work ethic #J-18808-Ljbffr Bayside Solutions