The Director of Operations will be responsible for the overall production management and material planning of a high-volume medical devices company. The ideal candidate will be a hands-on operations leader and have proven success with establishing a data driven operations team, meeting and/or exceeding production goals. We are looking for a leader who can bring standardization through a process-driven environment while inspiring positive culture and operational change in the production department.
Essential Job Functions:
- As a member of the Extended Leadership Team (ELT), participate in regular reviews, strategy, and action plans to drive growth and improvements in the business.
- Lead the production and planning team of 40+ employees to meet or exceed the production expectations while providing the customer with an exceptional transactional environment.
- Define and implement consistent and repeatable processes, methodologies to improve operational efficiency.
- Collaborate with other operational leaders to develop and execute the weekly/monthly/annual production plan by product family.
- Work closely with Finance partner on Cost Accounting, Inventory, Supply Chain and Manufacturing Analysis.
- Analyze inventory turns to optimize replenishment strategy and inventory levels.
- Evaluate effectiveness of inventory movement functions and transactions to ensure maximum throughput and stock visibility.
- Create a capacity analysis and constantly monitor business cycles.
- Ensure production and operation focus in established and maintained to achieve the company’s daily, weekly and longer-term goals for Revenue, On Time Delivery, Quality, and Safety
- Oversee and improve the productivity, deliverables, and order cycle times within production.
- Take ownership and execution of On-Time in Full and managing any customer backorders.
- Responsible for production labor efficiency and productivity as the primary goal, while establishing production labor standards.
- Coordinate and manage the weekly Production meeting with all Operational stakeholders.
- Responsible for establishing and maintaining strong internal relationships and establishing cross-functional collaboration with all departments to foster a strong, positive workplace.
- Responsible for establishing, monitoring, collecting, and reporting operational KPIs with the local management team.
- Together with Executive Management, develop and execute the capital equipment plan including identifying investments, building business cases, obtaining approval and implementing the new equipment.
- Ensure the industrialization and flawlessness of new product launch and modifications are carried out to best-in-class practice.
- Ensure compliance across the workplace, includes coordinating with QA/RA any site visits and audits of the operation.
- Accountable to maintaining an FDA approved production site, with an ISO 13485 operating standard.
Qualifications:
- 7+ years of Operations Management experience
- 5+ year of Production Planning experience
- Prior experience in a medical device manufacturing environment preferred
- Strong & proven leadership capabilities – able to make decisions with autonomy, speed, simplicity & scale
- Relentless drive to serve the customer and meet our delivery, quality, and safety goals
- Preferred experience with FDA and ISO13485 production
- Experience scaling a stand-alone business or business unit to over $50M
- Demonstrated success using metrics and data-driven decision making to improve operations
- Places extremely high value on being part of a team and promoting team success
- Acquisition and merger integration planning and experience a plus
- Entrepreneurial problem solver; risk taker and intellectually curious
- Ability to use and lead a production & planning department through the use of an ERP system
- Bilingual in Vietnamese a big plus
Competencies:
Integrity & Honesty
Manufacturing/Plant Manager experience
Planning & Organization
Excellent Communicator
Regulated industry experience
Leadership skills
Takes Initiative/Proactive
ERP Utilization
Lean six-sigma certified preferred
