Senior Engineering Manager - Medical Device - Waterbury, CT
You will lead the charge in developing smart, scalable, and compliant manufacturing methods that keep our medical devices at the highest standards. This role guides a team of technical experts and drives major initiatives-from production scale‑up to high‑volume manufacturing-that are essential to our growth and product excellence. Client Details The organization is a global company that develops, manufactures, and sells medical devices used in infusion therapy, oncology, and critical care. The company was founded in 1984 and has grown into a leading provider of innovative products for both hospitals and healthcare facilities. The company specializes in intravenous (IV) therapy systems, needle-free connectors, infusion pumps, and other related medical technologies. Description Support day‑to‑day production activities and maintain seamless manufacturing operations. Lead root‑cause investigations for non‑conformances and implement long‑term corrective and preventive actions. Identify and resolve recurring systemic problems. Collaborate with Manufacturing and Maintenance teams to enhance equipment and process performance, including improving yields, reducing scrap and material usage variance, shortening cycle times, addressing ergonomic concerns, and identifying maintenance requirements. Champion continuous improvement and lean manufacturing initiatives. Analyze yield challenges and recommend or influence the design and selection of equipment to lower costs and elevate product quality. Oversee all phases of multiple engineering projects. Enable team members to achieve project and organizational goals. Provide technical leadership for complex, non‑routine issues that require significant judgment in applying, adapting, and selecting engineering methods and best practices. Partner with suppliers and internal departments to secure needed resources, resolve cross‑functional challenges, and advance company objectives. Directly manage a team of engineers and engineering support staff, setting priorities aligned with business needs and available resources. Lead project and team meetings to address obstacles, review progress, share updates, and adjust priorities as needed. Supervise the creation of documentation associated with engineering tasks, including drawings, schematics, validation and capability test results, and new or updated operating procedures. Prepare reports and deliver presentations to leadership as required. Develop project schedules, including timelines and key milestones, to ensure on‑time and on‑budget delivery. Demonstrate company values and contribute to strategic initiatives. Perform additional duties as assigned. Ensure all company operations comply with applicable laws, regulations, industry standards, and internal procedures-including those related to environmental, health, and occupational safety requirements. Foster engagement and actively participate in Environmental, Health, and Safety programs, emphasizing ongoing improvement. Profile Knowledge & Skills Proficiency in Six Sigma methodologies, including DOE, process capability analysis, and Gage R&R. Strong understanding of Lean principles to enhance equipment performance, process efficiency, and overall production throughput. Experience using SolidWorks and familiarity with ASME Y14.5, ISO standards, and GD&T practices. Ability to maintain an in‑depth understanding of the product's clinical application and associated risks. Comprehensive knowledge of material strength, kinematics, dynamics, vibration, fluid flow, automation, plastic injection molding, assembly processes, fixturing, testing methods, and process control strategies. Understanding of the medical device industry and awareness of related regulatory requirements. Excellent analytical and problem‑solving skills. Minimum Qualifications, Education & Experience Bachelor's degree in Engineering or a related technical field; a Master's degree or MBA is preferred. At least 10 years of experience in medical device engineering or technology roles, including a minimum of 5 years in a leadership, supervisory, or management capacity. Strong background in injection molding, tooling, and automation. Job Offer Competitive salary ranging from $145,000 - $165,000 per year. Bonus Eligibility Comprehensive benefits package to support your well-being. Opportunities to work on challenging and impactful projects in Norwalk. A supportive and professional company culture. APPLY TODAY MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
