Director of Operations, Medical Device

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The 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 cGMPs

• Oversight of staffing, personnel scheduling, hiring and talent development of Operations team

• Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve

• Daily production output, including, but not limited to, new medical device production and servicing activities, prioritization to meet commercial demand

• Ownership 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 optimization

• Have 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 plan

• Own departmental budget planning and cost control; identify and drive cost savings initiatives without compromising quality or compliance.

• Direct and provide operational leadership for day-to-day cGMP device manufacturing production and service activities

• Coordinate 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 team

• Partner with Quality Assurance to develop and maintain metrics to ensure a holistic approach to meeting site RFT goals

• Evaluate deviations and trends to ensure the quality and integrity of processes, and final products

• Work cross-functionally with functional site leaders in the resolution of daily manufacturing issues, improving tools and processes, and establishing metrics

• Champion Operational Excellence and conduct Gemba walks to monitor activities on the floor and accomplish area objectives as well as to identify and resolve issues

• Provide continuous improvement suggestions for methods, technology, utilization of time and resources to help the team more effectively achieve business goals and objectives

• Identify and implement changes to improve the quality of products, processes & services

• Collaborate 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 manner

• Ensure 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 Practices

• Assist 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 processes

• Promote, champion and lead employee's awareness of company/department/site goals, expectations, policies, and procedures

• Serve 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 area

• Implement succession planning to build a resilient leadership pipeline and support long-term site sustainability

• Ensure ongoing performance and coaching dialogue between supervisors and team members

• Foster, build & support collaborative relationships at all levels of the organization as well as within external constituents through coordinated systems of training and development

• May perform other duties as required to meet business needs

Minimum Requirements:

• Bachelors degree in business, science, engineering or related field

• 10+ years' experience in Medical Device, Pharmaceutical, or other highly regulated industry required

• Hands-on background in site engineering and manufacturing operations

• Prior people management or supervisory experience with proven success in employee engagement and career development

• Strong leadership abilities with excellent communication and interpersonal skills across all organizational levels

• Proficient in ERP systems (SAP preferred), manufacturing techniques, equipment, and materials management

• Proficient in SAP and standard office software (ie MS Word, Excel, etc.)

• Skilled in time management, organization, and working independently to meet deadlines

• Experience applying Lean Six Sigma methodologies to drive process improvements

• Recognized people leader with deep operational expertise and a track record of results

• Effective change agent with a passion for continuous improvement and operational excellence

• Executive presence with strong presentation and influencing skills

• Demonstrated ability to manage competing priorities in fast-paced, dynamic environments

• Solid understanding of EHS and facilities requirements for manufacturing sites

• Knowledge of FDA regulations, ISO standards, and MDSAP expectations

• Prior audit experience a plus

Working Conditions:
Working conditions are typical for an office and light industrial environment.

Up to 10-15% domestic/international travel expected.

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