Engineer Sr, Quality Production Support

Job Description

Support the manufacture of medical devices. Work with Manufacturing and R&D Engineering teams to support manufacturing process changes, resolve product quality issues, and support the implementation of new products. Job duties:

• Work with Manufacturing Engineers on process improvement and cost reduction projects.
• Resolve product quality issues and manages non-conformance investigations and corrective actions.
• Lead/manage QAR/CAPA projects as assigned.
• Work with Supplier Quality Manager/Engineers to maintain high quality level of incoming production materials.
• Support process validation by developing or reviewing test protocols and reports.
• Support equipment qualifications by reviewing equipment specifications, IQ/OQ reports and unscheduled maintenance reports.
• Support internal and external audits by participating preparation activities and addressing audits findings.
• Work with R&D, Manufacturing Engineers, Regulatory, and Supply Chain Planner to support implementation of new products on Production floor.
• Work with R&D and Manufacturing Engineers to develop and update pFMEA based on non-conformance reports and complaints.
• Work with Manufacturing Engineers to perform product quality metric data analysis.
• Lead projects in improving effectiveness and efficiency of assembly inspection activities and cross-functional system-related processes.
• Perform other duties and responsibilities as assigned.

Qualifications

Bachelor's degree in Engineering or equivalent.

Minimum of four (4) years of engineering experience in medical device manufacturing industry.

Strong interpersonal and written and verbal communication skills.

Proficient computer skills including MS Word, Excel, and statistical software (e.g., MiniTab, Statgraphic, Design of Experiment DOE, etc.).

Desired Qualifications

Ability to understand the technology related to MicroVention's products.

Advanced knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).