VP Regulatory Affairs

Position Summary:

We are currently seeking a dynamic and skilled Senior Engineering Technician to join our Operations Engineering Department. This role requires a unique blend of technical knowledge, troubleshooting skills, and practical application in both electromechanical systems and manufacturing operations. The successful candidate will use their technical expertise and fundamental knowledge of electromechanical systems to improve the manufacturability of products, optimize test methods, and troubleshoot production issues.

• Conduct complex technical troubleshooting related to manufacturing, electrical and software issues.

• Utilize knowledge of electromechanical systems to identify, diagnose, and resolve production issues.

• Collaborate with the engineering team to design and implement test fixtures that ensure accurate and efficient testing of medical devices.

• Troubleshoot, debug, and optimize assembly test fixtures, identifying, resolving, and documenting issues to maintain accurate and reliable test results.

• Provide daily support of product lines and processes.

• Lead investigations of production failures and drive corrective action through the nonconforming material report (NCMR) process.

• Responsible for Preventative Maintenance (PM) and Calibration (CAL) of production equipment internally and at contract manufacturers.

• Analyze production data to identify trends, patterns, and areas for improvement, enabling proactive measures to enhance efficiency and optimize processes.

• Identify and lead continuous improvement projects focused on improving product performance and reliability, increasing capacity and process capability while reducing scrap and throughput time.

• Execute documentation changes (ECO’s) related to design, process, and test methods.

• Interpret and apply established SOPs and WIs to uphold quality standards and regulations.

• Work in adherence with the Quality Management System (QMS), including development and maintenance of documentation.

• Perform other duties as assigned.

• 2-year technical degree, or H.S. diploma + 7 years’ experience will be considered in lieu of degree
• 5+ years of experience in a similar role within a manufacturing environment.
• Ability to interpret drawings, schematics, and specifications.
• Experience in LabVIEW, C++ or other related programming languages.
• Strong troubleshooting and problem-solving skills.
• Effective oral and written communication skills.
• Moderate level of computer experience including MS Office Suite.
• Familiarity with metrology tools and techniques.

• 3+ years of experience in Medical Device or another regulated environment.
• 10+ years' experience in a similar role within a manufacturing environment.
• Demonstrated expertise using ERP systems, preferably SAP.
• Certified LabVIEW Developer (CLD) or higher.
• Proficiency in C++, Python, and PLC programming.
• Experience in CAD, preferably Solid Works
• Experience with Lean Manufacturing or Six Sigma methodologies.

• 2-year technical degree, or H.S. diploma + 7 years’ experience will be considered in lieu of degree
• 5+ years of experience in a similar role within a manufacturing environment.
• Ability to interpret drawings, schematics, and specifications.
• Experience in LabVIEW, C++ or other related programming languages.
• Strong troubleshooting and problem-solving skills.
• Effective oral and written communication skills.
• Moderate level of computer experience including MS Office Suite.
• Familiarity with metrology tools and techniques.

• 3+ years of experience in Medical Device or another regulated environment.
• 10+ years' experience in a similar role within a manufacturing environment.
• Demonstrated expertise using ERP systems, preferably SAP.
• Certified LabVIEW Developer (CLD) or higher.
• Proficiency in C++, Python, and PLC programming.
• Experience in CAD, preferably Solid Works
• Experience with Lean Manufacturing or Six Sigma methodologies.