The Technical Operations Manager has leadership responsibilities to ensure the successful manufacturing of in-vitro diagnostic products and medical devices, provide technical support to all functions within operations and lead NPI (New Product Introduction) activities for the company. The position is a key member of the management staff and will provide technical guidance and planning to ensure the growth of the companys existing and new product portfolio, while maintaining the highest quality standards. The manager will lead and interface cross-functionally with other team members (internal and external) to define, plan and execute company goals in a timely manner.
Duties and Responsibilities
- Provide technical guidance on issues pertaining to manufacturing and technical operations, oversee and coordinate the activities of technical staff. Lead scale-up operational activities to support the growth of the business.
- Provide sustaining support to manufacturing lines and ensure all manufacturing and process equipment and machinery are operational and efficient. Work with Manufacturing to establish routine monitoring of line efficiency and output.
- Work with key suppliers and collaborators to ensure technical specifications and performance requirements are aligned with company needs and policies.
- Liaise with other departmental heads to plan and implement action plans for improved technical operations.
- Work with Manufacturing to develop and implement health and safety policies to ensure a risk-free and safe work condition. Conduct risk assessments to analyze risks and operational hazards.
- Lead qualification and validation activities for new raw materials, processes, equipment, and products into Manufacturing. Lead transfer activities in accordance with company goals and policies.
- Maintain up-to-date knowledge of technical processes, functions, and requirements. Translate broad requirements into clear deliverables with actionable plans and outcomes.
- Oversee the hiring, training, and monitoring of technical operations staff. Mentor and motivate team members to excel at their level of performance and to achieve their highest potential. Conduct annual staff appraisals and assessments to determine staff training needs.
- Strong management experience in Manufacturing and/or Technical Operations within IVD and medical devices.
- Excellent organization, time-management, decision-making, interpersonal and communication skills are essential.
- A self-motivated individual and team leader that is detail-oriented excels at problem-solving and can function both independently as well as part of a team is required.
- Must be able to work and contribute to a highly collaborative and fluid environment on multiple projects concurrently.
- Applicants should minimally have 5+ years of management experience, preferably leading a technical team; hold a B.S./B.A. in a life science or engineering discipline with 8+ years or M.S. with 5+ years experience.
- Leadership experience in medical device and in-vitro diagnostics a must, and commercial blood chemistry diagnostics and automation a definite plus.
- Solid understanding of QMS, cGMP, and FDA/ISO regulations.