The Senior Manager, Manufacturing Engineering oversees a team of engineers responsible for activities related to the successful transition from R&D pilot production to manufacturing and continued through sustained commercialization. This position works on the development and continuous improvement implementation of production processes, systems and equipment needed to meet the manufacturability of, and the improving quality and cost reduction of, company products. This position ensures that all products are developed and manufactured in compliance with validation protocols, company Quality System, budgetary requirements and regulatory requirements of countries where products will be marketed.
Coach a team of engineers in developing technical skills to assess manufacturing capabilities and define proper design transfer requirements to reduce waste and establish smooth and effective processes.
Manage, develop and engage a group of manufacturing engineers to meet projects goals and objectives while striving for a significant and measurable business impact in a quality driven team-based manufacturing environment.
Lead initiatives to achieve manufacturing KPI goals in safety, quality, delivery, inventory, and cost.
Identify cost improvements through design, process development, and manufacturing strategies, and lead teams in the implementation of these improvements.
Work with operations leaders to implement and execute strategic project management plans, set priorities and timelines and achieve company goals for commercialization and production of stable products.
Collaborate with Operations, R&D, Quality and other cross-functional stakeholders to understand product development and business needs to establish manufacturing processes that meet those needs.
Evaluate and recommend changes needed to ensure manufacturability of products in accordance with design specifications, Quality Systems, Operator ability and within cost requirements.
Determine most effective use of resources to drive GMP, lean principles and quality concepts across the business and with contractors. Participate in the research, evaluation and implementation of contract manufacturing programs that meet design, budget requirements and quality systems standards.
Ensure all company products are designed, developed, tested, manufactured, and documented in accordance with regulatory requirements for approval of products by US and foreign regulatory agencies
Recruit and retain a team of employees whose skills meet the needs of the organization and who are engaged in the goals of the company.
What You'll Bring
BS/MS in Mechanical, Manufacturing or Industrial Engineering or related discipline; and 8+ years of experience in this field with progressive experience in managing a team in a medical device or related industry; or an equivalent combination of education and experience.
Lean Six Sigma Black Belt preferred
Experience working in compliance with Quality Systems designed to meet regulatory requirements, such as but not limited to FDA QSR ISO 13485, MDD etc.