Job Details

ID #8609223
State California
City Fremont
Job type Not Specified
Salary USD Competitive Competitive
Source Bayside Solutions
Showed 2021-01-26
Date 2021-01-25
Deadline 2021-03-26
Category Manufacturing
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Technical Operations Manager

California, Fremont, 94536 Fremont USA

Vacancy expired!

Bayside Solutions is seeking an Assay Development Scientist to work with our client in Fremont, CA.

Technical Operations Manager

Summary:

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 company s 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 growth of 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 an 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.

QUALIFICATIONS:

  • Strong management experience in Manufacturing and/or Technical Operations within IVD and medical device.
  • Must be able to work and contribute to a highly collaborative and fluid environment on multiple projects concurrently.
  • 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.

Vacancy expired!

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