Responsibilities
* plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
* may develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
* oversees the investigation and evaluation of existing technologies.
* guides the conceptualization of new methodologies, materials, machines, processes or products.
* directs the development of new concepts from initial design to market release.
* manages feasibility studies of the design to determine if capable of functioning as intended.
* monitors documentation maintenance throughout all phases of research and development.
* organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
* selects, develops and evaluates personnel to ensure efficient operation of the function.
people management & leadership
management and supervisory professionals with one or more employees focused on tactical, operational, and some strategic activities within a specified area. Responsibilities include overseeing area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing, and directing responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and/or indirect reports. Key responsibilities include mentoring, developing and coaching staff, providing leadership, conducting performance reviews, 1:1s and guiding performance management and employee development efforts.
key differentiators
* autonomy: supervises team members or subordinate supervisors, providing tactical and/or technical leadership. Performs ongoing operational tasks and delivers results according to established procedures.
* organizational impact: plans and establishes goals and objectives for a team, making decisions that affect project or department schedules, customer satisfaction, and resource allocation. May manage day‑to‑day budget elements.
* innovation and complexity: makes improvements to processes, systems or products, tackling difficult problems that require understanding of multiple job areas or specialties.
* communication and influence: communicates with internal and external customers and vendors across various organization levels, exchanging information to reach solutions and gain cooperation.
* leadership and talent management: second‑level supervisor of employees in the support stream or first‑level supervisor in specialist stream, leading and reviewing work to achieve operational plans. Provides input to hiring, firing, promotion, performance and reward decisions for direct reports.
qualifications
* baccalaureate degree (or equivalent) in industrial, electric, mechanical engineering or related field.
* minimum 3 years of relevant experience, or an advanced degree with minimum 1 year of relevant experience.
* 10 years of experience in a similar position.
* experience with autocad/ solidworks for designing/re‑designing tooling, fixtures, and production lines.
* experience in product transfers, new product introduction.
* experience in process automation and crisis management.
* experience in capacity studies, lean implementation/improvements and product costing.
* advanced level in ncmrs, customer complaints, capas and validations (processes and product).
* finance knowledge and experience (savings and capital projects, aop).
* knowledge of cgmp, iso 13485:2016.
* lean/black belt certification.
* intermediate proficiency in excel, word, powerpoint.
* english proficiency 80%.
* personnel management experience.
physical job requirements
general nature of work involves supervision, review, and occasional travel. No job‑specific physical demands beyond those listed in the full position description.
benefits & compensation
* competitive salary and flexible benefits package.
* eligible for the medtronic incentive plan (mip).
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