The Opportunity This position works out of our Alajuela, Coyol location in the Electrophysiology business unit. EP is advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.The Engineering Manager will manage the planning and completion of manufacturing engineering activities in order to meet production goals, while enhancing product quality and productivity.What You'll Do MAIN RESPONSIBILITIESDefines department strategic objectives.Leads the team to maintain Key performance indicators under control.Provides leadership to engineering staff regarding project prioritization, process validations, and continuous improvement activities.Coaches, manages, and develops technical staff and functional team members.Provides prioritization & allocates engineering resources, according to business needs.Maintains engineering headcount according to budget.Assures validation activities, manufacturing practices and documentation comply with quality & regulatory requirements.Periodically reviews and analyzes KPI's data and trends.Looks for and applies industry best practices related to equipment and process qualification.Assures manufacturing lines have equipment requirements fulfilled according to production plan.Understands potential risks related to product malfunctions.Participates with external cross functional teams (i.e., RA, R&D, QA) representing the ME function.Leads global initiatives with other functions and sites.Leads CAPA investigation processes or provides support allocating resources and implementing corrective/preventive actions.Leads complex projects as project manager: new product introduction, substantial product changes, line expansions, etc. Drives continuous improvement projects according to plan.Uses product cost structure knowledge to identify risks and opportunities.Has advance knowledge of medical devices regulations: i.e., FDA's 21 CFR Part 820 (Quality System Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures) and ISO 13485.Understands financial structure of the organization and its interactions with results.Utilizes KPI's information to provide inputs for the financial cycle (LBE).Assures financial results are according to budget.Evaluates the financial, process or quality impact, derived from product & process changes.Required QualificationsBachelor's degree in engineering in STEM career technical fields such as: electrical, materials, mechanical, etc.7 years of experience in manufacturing/process development experience, with minimum 5 years people management.Experience with continuous improvement methodologies. Such as Lean Manufacturing techniques, value stream mapping, or similar.Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.Experience in project management involving coordination of cross functional teams.Solid knowledge of GMP, ISO regulations. Experience with statistical techniques (e.g., DOE, SPC). Computer software knowledge (Microsoft Word, Excel, Power Point).Fully Bilingual (English and Spanish).Preferred QualificationsMaster's degree in technical area.Certification in project Management, Black Belt.
