Lead released product management (RPM)/sustainment programs. Provide technical and engineering insights on energy-based products to assess impact of changes on overall function and performance of devices. Evaluate design and process impacts for changes incorporated as a part of remediation effort addressing field complaints and supplier component changes. Coordinate Voice of Customer (VOC) activities and formative and summative studies. Ensure compliance by navigating and adhering to government and industry regulations including FDA QSR 21 CFR 820, ISO 13485 (Medical Device), ISO 10993 (Biocompatibility), IEC 62366 (Usability Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software Development Life Cycle). Responsible for executing projects and ensuring effective collaboration with team members across different time zones and cultural environments. Utilize Monte Carlo simulations to assess and quantify risks and uncertainties across all phases of the project lifecycle, including design, development, testing, regulatory approval, and production. Conduct changes within the SAP environment, including SAP S/4HANA, SAP ECC and HP ALM to drive system enhancements, troubleshoot issues and ensure alignment with business processes. Define, execute, and document validation protocols Installation Qualification, Operational Qualification, Performance Qualification (IQ/OQ/PQ). Lead the design and development of precision components for Injection Molding, Extrusion, and CNC Machining while conducting tolerance stack-up analysis to ensure dimensional accuracy and reliable performance in complex assemblies. Leverage CAD tools including PTC Creo, Minitab, SolidWorks, and AutoCAD within the design team, promoting best practices for 3D modeling, technical drawings, and design validation. Implement Design of Experiments (DOE), oversee the CAPA process and Non-Conforming Material Report (NCMRs). Responsible for strategic development, design, regulatory compliance, and clinical validation of Cerebrospinal Fluid (CSF) and cranial products, ensuring alignment with market needs, safety standards, and company objectives while collaborating with cross-functional teams to drive innovation and product success. Leverage knowledge from being a certified six sigma black belt by American Society of Quality (ASQ) or equivalent certifying agency. 10% international or domestic to suppliers and users. This is an individual contributor position with no direct reports. Relocation assistance not provided.
Bachelor's degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering degree and five (5) years of experience as a manufacturing engineer or related engineering occupation; OR Master's degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering degree and two (2) years of experience as manufacturing engineer or related engineering occupation. Requires a minimum of 2 years of experience in each of the following: FDA QSR 21 CFR 820, ISO 13485 (Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) and EN 62304 (Software Development Life Cycle); Collaborating with international team members; MS projects using Monte Carlo simulation; SAP S/4HANA, SAP ECC and HP ALM; IQ, OQ and PQ; Design for Injection Molding, extrusion, CNC machining and Tolerance stack up analysis; PTC Creo, Minitab, Solidworks and Auto CAD; DOE, CAPA and NCMR; and Working with Cerebrospinal Fluid (CSF) products. The following certification is required: Certified six sigma black belt by American Society of Quality (ASQ) or equivalent certifying agency. Travel requirement: 10% international or domestic to suppliers and users.
Salary: $163,000 to $204,000 per year
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
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