Manager, Product Lifecycle

We are seeking a hands-on Engineering Manager to lead sustaining engineering and product development efforts within a growing medical device organization. This is a manager-level role focused on supporting and improving existing products rather than leading early-stage R&D.The position oversees a small but growing team (currently 2 direct reports, expected to expand to 3+) and plays a critical role in ensuring products remain compliant, manufacturable, and aligned with current standards.Key areas of focus include sustaining engineering, product updates (including acquired product lines), packaging changes, shelf-life extensions, and design control activities.Key ResponsibilitiesSustaining Engineering & Product SupportLead efforts to maintain and improve existing medical device productsDrive design changes, updates, and enhancements to ensure compliance and performanceSupport packaging updates, shelf-life extensions, and product lifecycle initiativesOwn design control processes, including documentation, testing, and regulatory alignmentProject LeadershipLead critical initiatives such as packaging changes and product updates from concept through implementationOversee design verification, validation, and package integrity testingEnsure projects are executed efficiently and completed successfullyAcquisition Integration & Product ImprovementAssess and improve newly acquired product linesIdentify gaps in design, compliance, and documentationImplement best practices to bring products up to current standardsTeam LeadershipManage and develop a team of engineersSet goals, lead project planning, and conduct regular 1:1s and performance reviewsFoster a collaborative, high-performing team environmentCross-Functional CollaborationPartner closely with Quality, Regulatory, Manufacturing, and Operations teamsIdentify issues, propose solutions, and drive continuous improvement initiativesQualificationsRequiredBachelor’s degree in Engineering or related field7+ years of experience in the medical device industryStrong knowledge of:Design ControlQuality Management Systems (QMS)Experience working in FDA-regulated environmentsProven ability to lead projects and drive initiatives to completionPreferredPrior leadership or people management experienceExperience in vascular or cardiovascular medical devicesFamiliarity with:ISO 13485ISO 14971 (risk management)Background in sustaining engineering or post-market product support