Ximedica is an ISO 13485 certified and FDA registered full-service product development firm with offices in Providence, Minneapolis, San Francisco, Silicon Valley, and Hong Kong. We have an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.
We have a high-energy collaborative culture that fosters the creative spirit while exceeding client expectations. We offer tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours.
Position: The Senior Manager, Manufacturing Operations develops and executes manufacturing plans to meet demand for our medical device and laboratory equipment clients.
Nature of Role: Reporting to the Vice President of Manufacturing Solutions, as a key member of the management team, this individual ensures device GMP regulations are in place while also driving continuous process improvement activities to increase efficiency and productivity. Managing a staff of 10+, he/she possesses the skills to provide leadership, coaching and mentoring to his/her team.
Requirements: A Bachelor’s degree in Engineering/Science, with a Master’s degree is preferred. A minimum of 10 years of experience with at least 3 of those in a senior role, in the medical device arena is required. The following key attributes are sought:
- Familiarity with appropriate FDA, QSR, and ISO regulations: design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device industry knowledge
- Experience managing cross-functional teams, project facilitation, and a demonstrated ability to complete projects on time
- Ability to analyze resource commitments, project success criteria and other key indicators to provide interventions/adjustments as needed
- Maintain constructive and respectful relationships with people at all levels within and outside of the organization
- Ability to deliver measurable results that equal or exceed stretch targets
- Successful communication skills, business acumen and assertive decision-making ability
- Flexibility to multi-task and perform a wide range of activities
- Excellent computer skills, including MS Office proficiency
- Advanced understanding of MRP systems and proficiency in their use
- Coordinate with management to develop performance measurement criteria consistent with the business plan
- Work closely with Advanced Manufacturing Engineering group in support of new product development and manufacturing transfer activities
- Manage Production group in support of product manufacturing, including Manufacturing Assemblers and Production Planning.
- Conduct Device History Record reviews for manufacturing
- Ensure appropriate manufacturing capacity by projecting requirements for trained employees, space, equipment and other assets – and planning for their acquisition
- Manage the control of all manufacturing inventories through physical and system audits, reconcile discrepancies, and provide relevant information to other departments for adjustments
- Develop, implement, and maintain policies and procedures for Production
- Develop long term manufacturing strategies by estimating, forecasting and anticipating trends & requirements
- Work with other departments (Quality, Engineering, and Supply Chain) to reduce cost, cycle time, and scrap
- Select, train, mentor, motivate, and evaluate staff
- Lead and communicate daily production goals to the manufacturing team
- Assures all Ximedica products are manufactured on equipment that is in 100% compliance with Ximedica’s Preventative Maintenance and Calibration requirements
- Analyze problems, recommend changes and develop new processes and procedures
- May be responsible for Program Management of activities of contract manufacturing, manufacturing transfer, or other programs
- Ensure the delivery of programs to specification and budget
- Engage in Ximedica continuous process improvements, best practices development, and education activities.
- Manage relationships and communicate with sub-contractors, proactively monitoring quality of deliverables & their resources
- Other activities as determined by the Vice President of Manufacturing Solutions