Senior Electrical Quality Engineer

June 11

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CVRx | Barostim

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CVRx’s Barostim is a breakthrough technology that stimulates the body’s natural baroreflex to treat heart failure

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Description

• Lead the charge in ensuring top-notch quality and reliability for new hardware, firmware, and software development projects. • Take the helm in managing and documenting risk management activities, including reliability analysis, risk and hazard assessment, FMEA, and hazard analysis. • Ensure seamless compliance with quality systems, risk management, and medical device standards, encompassing cybersecurity and usability, while maintaining crucial regulatory documentation. • Review and green-light design and development documents, protocols, and reports for hardware, software, and firmware. • Oversee design validation testing and reporting, generating essential protocols and reports. • Craft or review Test Plans and Reports for production and qualification tests. • Manage Nonconforming Material Reports, Deviations, and Product holds to bolster manufacturing operations. • Document process FMEA and offer insights for process evaluations, qualifications, and validations. • Spearhead supplier and component selection and qualification, along with equipment selection and qualification. • Execute statistical analysis and provide sample size inputs for qualification/validation testing. • Tackle CAPA issues, investigate returned products and complaints, and perform root cause analysis and health hazard assessments. • Produce and review non-product software documentation related to field support, manufacturing, and development applications. • Assist with internal audits to ensure regulatory compliance. • Drive continuous improvement strategies for quality functions. • Conduct Gage R&R studies and meticulously document results. • Embrace miscellaneous duties as assigned to uphold excellence in quality and reliability.

Requirements

• BS Degree in Science or Engineering or technical equivalent plus 5 years or more experience in a medical device company. • Knowledge of FDA QSR and ISO 13485 as well as EU MDR regulatory requirements, guidelines and standards that pertain to medical devices. • Class II or Class III medical device experience. • Proven communication, analytical, organizational, and problem solving skills. • Ability to interface with internal and external customers in all aspects of the product life cycle. • Ability to apply statistics to solve problems and determine sampling plans. • Experience with risk and hazard analysis.

Benefits

• Company Paid Health & Dental Insurance options. • Company contributions to an HSA if enrolled in a high deductible plan. • 401(k) with company match. • Employee stock purchase plan & stock option grants. • 12 company paid holidays per year + PTO. • Paid time off for new parents. • Company paid life insurance & disability. • Unlimited growth opportunities. • Training & learning opportunities. • Flexible Schedules. • Rewards & Recognition Programs. • Employee Referral Program. • Companywide events. • Additional employee perks & discounts.