Job Title Director of Operations, Medical DeviceRequisitionJR000015183 Director of Operations, Medical Device (Open)LocationMadison, WIAdditional LocationsJob Description SummaryJob DescriptionThe Director of Operations – Medical Device will provide strategic direction and leadership for all aspects of operations at the site. This individual will play a critical role in achieving the site's goals and objectives, developing and implementing standardized operating philosophies, processes, procedures, and practices across production operations to improve manufacturing safety, quality, cost, and customer service. This individual will ensure that approved products are manufactured and supplied on schedule meeting quality standards. This critical role is part of the Site Leadership Team (SLT) and is expected to work independently with above-site stakeholders to achieve business results in a collaborative manner.Key responsibilities include effective planning, directing, coordinating resources, for the site operations to ensure performance, productivity, and efficiency of the entire device assembly floor. Specifically, this role has ownership of the following:Drive the development and execution of short- and long-term operational strategies aligned with corporate goals, while establishing and tracking KPIs to measure safety, quality, delivery, cost, and People (SQDCP)Ensure that the manufacture of product is performed in a safe, compliant manner, meeting the regulatory requirements defined in relevant health authority submissions and cGMPsOversight of staffing, personnel scheduling, hiring and talent development of Operations teamBuild and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improveDaily production output, including, but not limited to, new medical device production and servicing activities, prioritization to meet commercial demandOwnership of process efficiencies and manufacturing-related documentation, such as batch records, deviations, investigations, etc.Support company sustainability goals through environmentally responsible manufacturing practices and energy/resource optimizationHave direct responsibility for or work cross-functionally with teams including: Manufacturing, Service, Facilities, Sustaining Engineering, Global Device Engineering, Supply Chain/Materials Management, EHS, Quality, Regulatory, etc.Ensure Site Compliance with Health and Safety, Environmental, and Regulatory requirements.Manage preparation, implementation, and maintenance of integrated risk management planOwn departmental budget planning and cost control; identify and drive cost savings initiatives without compromising quality or compliance.Essential FunctionsDirect and provide operational leadership for day-to-day cGMP device manufacturing production and service activitiesCoordinate with Global Supply Chain Planning to develop schedules to meet business targets. Communicate and ensure understanding of area objectives, schedules, procedures and issues to Operations teamPartner with Quality Assurance to develop and maintain metrics to ensure a holistic approach to meeting site RFT goalsEvaluate deviations and trends to ensure the quality and integrity of processes, and final productsWork cross-functionally with functional site leaders in the resolution of daily manufacturing issues, improving tools and processes, and establishing metricsChampion Operational Excellence and conduct Gemba walks to monitor activities on the floor and accomplish area objectives as well as to identify and resolve issuesProvide continuous improvement suggestions for methods, technology, utilization of time and resources to help the team more effectively achieve business goals and objectivesIdentify and implement changes to improve the quality of products, processes & servicesCollaborate with QA to ensure processes and/or production methods are maintained within their qualified state, and that non-conformances or investigation results are communicated and addressed in a timely mannerEnsure that the production groups are properly trained, and employees perform duties according to approved Manufacturing policies, Standard Operating Procedures, guidelines for Safety, and all applicable current Good Manufacturing PracticesAssist in development and revisions of Standard Operating Procedures (SOP), Work Instructions (WI), device history records (DHR), and other quality documentation, as necessary, to support production processesPromote, champion and lead employee’s awareness of company/department/site goals, expectations, policies, and proceduresServe as direct manager to manufacturing team leaders/managers and indirect management of about 50 employees, including contractors. Responsible for the professional development of both direct and indirect level employees in the device manufacturing areaImplement succession planning to build a resilient leadership pipeline and support long-term site sustainabilityEnsure ongoing performance and coaching dialogue between supervisors and team membersFoster, build & support collaborative relationships at all levels of the organization as well as within external constituents through coordinated systems of training and developmentMay perform other duties as required to meet business needsMinimum Requirements:Bachelors degree in business, science, engineering or related field10+ years’ experience in Medical Device, Pharmaceutical, or other highly regulated industry requiredHands-on background in site engineering and manufacturing operationsPrior people management or supervisory experience with proven success in employee engagement and career developmentStrong leadership abilities with excellent communication and interpersonal skills across all organizational levelsProficient in ERP systems (SAP preferred), manufacturing techniques, equipment, and materials managementProficient in SAP and standard office software (ie MS Word, Excel, etc.)Skilled in time management, organization, and working independently to meet deadlinesExperience applying Lean Six Sigma methodologies to drive process improvementsRecognized people leader with deep operational expertise and a track record of resultsEffective change agent with a passion for continuous improvement and operational excellenceExecutive presence with strong presentation and influencing skillsDemonstrated ability to manage competing priorities in fast-paced, dynamic environmentsSolid understanding of EHS and facilities requirements for manufacturing sitesKnowledge of FDA regulations, ISO standards, and MDSAP expectationsPrior audit experience a plusWorking Conditions: Working conditions are typical for an office and light industrial environment.Up to 10-15% domestic/international travel expected.#LI-LM1
