Overview:

Reporting to the CEO, the VP, Operations (VPO) will lead the companys' operations, including responsibilities for

1. Supporting/Oversight of Engineering/Product Development (per Design Controls),

2. GMP Manufacturing (primarily outsourced),

3. Quality,

4. Regulatory submissions and compliance,

5. Logistics (warehousing, distribution, facilities),

6. Procurement and A/P,

7. other responsibilities at the request of the CEO

The VPO collaborates closely with the CFO/Controller on financial modeling, expense forecasting, and cash flow reporting. This role ensures the company's QMS remains FDA and ISO 13485 compliant, both directly and through delegation, while maintaining adherence to all relevant regulatory standards. The VPO manages regulatory submissions for the company’s regulated medical devices, utilizing external consultants. Additionally, the role includes overseeing logistics such as company facilities, warehouse inventory and distribution, as well as coordinating technical and customer support alongside the VP of Sales & Marketing and their team. The VPO is responsible for leading all production operations to ensure the distribution of high-quality products at a cost-effective rate. This individual also oversees human resource functions, identifies staffing needs, hires personnel with appropriate approvals, and fosters a high-performing team structure that supports the company’s strategic objectives.

Major Responsibilities:

1. Responsible for all human resources activities. Source and create a high-performance organization in a hybrid structure comprised of direct employees (per approved staff plans) and outsourced services providers and contractors. Manage all services associated with recruiting, payroll, benefits and employee issues.

2. Source and leverage technical expertise via contractors and consultants, combined with hands-on activities to support engineering of the company’s products. As delegated by the CEO, provide oversight of the Dir of Product Development, related staff and development efforts with emphasis on repeatable, reliable and manufacturable product designs and transfer of those successful designs into routine production.

3. Responsible for all aspects of production, warehousing, distribution and procurement. Source and leverage contract manufacturers for production of the company’s products including prototypes and test samples during development. Source and leverage services for logistics, purchasing and A/P processing in collaboration with the CFO/Controller to support financial planning and reporting.

4. Responsible for all aspects of the company’s regulatory compliance and submissions. Source and leverage experienced consultants (or employees) to support the company’s needs in QMS management, design assurance and regulatory filing, submissions and audits. As delegated by the CEO, oversight of the Dir of RAQA and related staff and activities.

5. Support the CEO for grant and investor fundraising.

6. In collaboration with the CEO, develop and communicate operating plans that align with corporate goals and objectives and drive the company’s business success.

7. Foster a culture of collaboration, accountability and high performance. Display and practice a visible, open leadership style throughout the organization. Provide critical direct support to the CEO as requested.

8. Work collaboratively with internal teams to provide feedback in a variety of internal processes, including new product development, customer service, order fulfillment and quality. Lead by example.

Requisites

1. A minimum of 15 years participating in medical device development and leading manufacturing operations (transition from development) with progressive positions of increasing responsibility. a. Emphasis on related experience with sterile, disposable devices.

2. A minimum of 10 years overseeing QMS development, implementation and management.

3. A minimum of 5 yrs overseeing logistics of facilities, Inventory warehousing, distribution, customer service support, etc.

4. Prior experience supporting financial reporting, working with financial management of the company, procurement and A/P support.

5. Prior experience and demonstrated ability to manage (hire and fire) a direct team of managers, engineers, and service providers.

6. Prior experience with early stage, e.g. startup, medical device companies and commercialization of products operating under financial and resource constraints and challenging schedules.

7. Prior experience with support of human resources, employment issues and administration of payroll and benefits, etc.