Product Quality Engineer- Medical Device

The Sr. Product Quality Engineer provides design quality expertise to product development teams, ensuring patient/user safety, customer satisfaction, and organizational success. This role involves leading risk management activities and supporting a broad range of development quality functions.Key Responsibilities:Lead and support on-time completion of Design Control deliverablesEstablish objective, measurable, and verifiable product requirementsPlan and execute Design Verification and Validation, including investigations and resolution activitiesLead risk management from product concept through commercializationSupport test method development and validationAssist with manufacturing process development and qualification for new products and design changesDefine component specifications, sampling plans, and vendor qualificationsSupport biocompatibility and sterilization qualificationsParticipate in audits and quality system improvement initiativesSupport organizational initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory complianceMaintain collaborative communication with all levels of employees, contractors, and suppliersBasic Qualifications:Bachelor’s degree in Engineering or related technical fieldMinimum 5 years of experience in R&D, process/manufacturing engineering, or quality, with at least 2 years in product developmentExperience in medical device regulations and standardsExperience in test method development and validationExperience preparing risk assessments, FMEA, and other risk documentationPreferred Qualifications:Advanced degree in Engineering or technical fieldExperience with active implantable medical devicesFamiliarity with requirements management tools (e.g., DOORS) and problem reporting systems (e.g., JIRA)Working knowledge of statistics applied to verification and validationPay Range: $40/hr to $50/hrThe Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).