Sr Principal Engineer

Job Summary

The Sr. Principal Engineer, Quality, supports CAPA activities, quality metrics, process improvements, change control, product lifecycle initiatives, and regulatory compliance. Serves as the primary Quality contact for hardware, software, and disposable product issues. This role coordinates cross-functional teams, drives timely issue resolution, manages customer-facing investigation documentation and communications, and monitors complaint trends. The position also in partnership with Commercial, R&D, Production Units, and other functions, the role advances product quality, reliability, and customer satisfaction.

Applies broad knowledge of practices used by disciplines outside the primary area of expertise to develop new or improved products and processes. Plans, executes, and functionally directs key assignments requiring independent judgment, with responsibility for product quality, regulatory compliance, and adherence to company policies.

Responsibilities

• Develop, implement, and monitor various quality metrics on a local and global level from both a Design Center and Market Unit perspective.
• Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for monthly CAPA Review and Product Review meetings, as well as annual reports.
• Guides the conceptualization, development, evaluation, and implementation of new or improved methodologies, processes, and tools for product and/or process changes.
• Gather and analyze data for root cause analysis for complaints, CAPA, and/or SCARs. Coordinate and drive efforts to assure CAPAs and associated projects are opened and completed appropriately. Work with Engineering and Manufacturing to develop and implement corrective actions.
• Support Post Market Surveillance through complaint sample evaluations and investigations.
• Track, trend, and escalate recurring product issues by analyzing complaint data in the context of field use, complaint severity, recurrence, customer impact, and potential product or patient risk.
• Manage or coordinate follow-up activities in response to actionable trends, including escalation for CAPAs, design changes, risk-management activities, including proposals on field corrective actions, or sustaining projects, as applicable.
• Serve as the primary Quality Assurance contact for customer communications and/or regulatory inquiries, coordinating timely, accurate, and compliant responses; perform documented risk assessments and analyses to evaluate product quality, patient or user safety, regulatory impact, and the need for escalation or additional corrective action.
• Serve as the primary contact for local and global product complaints and SCAR responses, maintaining a comprehensive status summary that covers investigation progress, open actions, responsible functions, documentation, risks, and target completion dates.
• Coordinate cross-functional technical investigation activities with Production Units (PUs), R&D, Commercial, Field Service, and other applicable functions to assess complaints, support root-cause determination and issue resolution, maintain visibility and accountability for complaint status, task ownership, dependencies, risks, and delivery timelines, and identify and escalate barriers requiring additional resources, technical or field support, or management action.
• Provide quality support for New Product Development. Incorporate knowledge of customer use and product design to predict product effectiveness and anticipate potential failures.
• Influence requirements definitions and ensure that reliability, quality, and safety requirements are met.
• Mentor and coach Engineering with the development of test protocols and reports.
• Act as a subject matter expert in Change Review Board as part of the change control process.
• Ensure compliance to regulatory requirements. Uphold quality system. Support internal and external audits.
• Advise senior management regarding appropriate actions.

Requirements

• B.S. degree in Science or in Engineering; CQE certification a plus.
• 8+ years’ experience in of Medical Device (21 CFR 820) and/or Drug (21 CFR 210 & 211) related industry. Quality engineering or Product Development experience preferred.
• Experience with Post Market Surveillance a plus.
• Minimum 1 year of leadership/supervisory responsibility.
• Working knowledge of lean manufacturing, Six Sigma, and Project Management principles.
• Understanding and working experience with EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control, document controls, design verification and validation, hazard analysis techniques, and regulatory approval methods.
• Knowledge of quality control process and statistical techniques.
• Understanding of manufacturing processes and techniques.
• Ability to solve unique and complex problems. Strong attention to detail.
• Proficient with Excel (PivotTables, trending, charting).
• Exercises sound judgment without supervision on complex projects. Leads cross functional groups to resolve issues and contribute to area development.
• Excellent verbal and written communication skills.
• Strong interpersonal skills and the ability to work with cross-functional teams.
• Preferred to have relevant Industry Experience.