Director of Manufacturing Engineering

5 days ago

Valencia, California, United States Valencia Technologies Full time
Position/Title: Director Manufacturing Engineering

Department: Manufacturing Engineering

Supervisor: VP of Business Operations & Clinical Affairs

FLSA Status: Exempt

About the Company: Valencia Technologies is a neuromodulation company transforming the standard of care for urgency urinary incontinence with the development of our revolutionary eCoin technology. Valencia Technologies is ramping up all aspects of business to deliver effective therapy and impact the lives of millions. Join our mission to become the market leader in overactive bladder care as we bring patients and physicians a better therapy now and beyond, put patients first, and be a place of respect, excellence, and honesty for our employees and clients.

Job Summary: The Director Manufacturing Engineering leads the manufacturing engineering function (projects, processes and people) within Valencia Technologies for the entire product portfolio (Medical Class III products, active implantable devices). As a functional leader, the Director will supervise and coordinate the activities of all levels of managers and engineers. The Director provides hands-on leadership, assesses and develops talent, and ensures projects are staffed appropriately. This involves close coordination with R&D and Manufacturing/Production as well as regular interaction with Quality, Regulatory, and other business functions.

The Director Manufacturing Engineering is responsible for managing and overseeing the following functions:

• New Product Introduction

• Sustaining Product & Process Engineering

• Process Development (including process verification/validation)

To be successful in this position, the person must be able to multi-task, change priorities as needed, produce high quality work product, and be able to communicate effectively at all levels of the organization.

Responsibilities/Tasks: As Director Manufacturing Engineering, you will be responsible for:

• Managing the resources, assignments and deliverables within the Manufacturing Engineering team

• Developing and driving the vision, roadmap and execution plans for manufacturing engineering solutions and projects to provide prioritized product solutions, meet or exceed functional excellence standards, and ensure that technical decisions are aligned with longterm engineering priorities.

• Leveraging process improvement methodologies to foster a continuous improvement culture while driving positive changes to current projects.

• Creating and promoting an internal culture that challenges the status quo, is excited to solve tough problems and adapts to change in order to create a significant, measurable and positive impact for the company as well as the patient's lives that our products touch.

• Collaborating with cross-functional stake holders such as Operations, Quality, Manufacturing, R&D, Regulatory, and others to ensure alignment on project scope, design control documentation, quality and schedule.

• Ensuring all manufacturing engineering activities are compliant with the regulatory bodies and international standards.

• Ensuring compliance to appropriate design control requirements, including risk management, validation and verification procedures, design history files and best practices.

• Driving and leading team initiatives to remediate CAPA projects.

• Attracting, hiring, developing, and motivating qualified engineering resources. Retain high potential/high performing employees with engagement initiatives.

• Creating key performance indicators (KPI), process and product quality metrics to assess the success of projects. Use KPI's to make continuous process improvements.

• Reviewing and approving manufacturing engineering technical documents and participate in manufacturing engineering technical reviews.

• Holding task owners accountable for delivering on time and with high quality. Identify project risks proactively and countermeasures to mitigate the risks.

• Preparation of and adherence to annual budget plans, inclusive of staffing levels, expense planning & capital expenditure (CAPEX) spending necessary to achieve approved projects and programs.

• Ensuring that all direct reports are familiar with, trained on and follow all Quality System procedures related to their jobs which can affect the quality of products or services provided to our customers and that changes to procedures are reviewed, approved and validated prior to implementation.

Duties include the exercise of discretion and independent judgment with respect to matters of significance.

Qualifications:

• Min. 10 years' experience in the manufacturing engineering capacity for class III Medical devices.

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field

• Extensive experience in manufacturing engineering, including process development, automation, and quality control

• Strong leadership and team management skills

• Proven ability to analyze data, identify trends, and implement data-driven decision making

• Excellent communication and interpersonal skills to collaborate effectively with crossfunctional teams

• Knowledge of Lean Manufacturing principles and continuous improvement methodologies

• Experience with project management tools and techniques

• Working knowledge of Microsoft Office

Benefits:
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • 401K with Employer Matching
  • Paid Time Off
  • Paid Holidays
  • Professional Development Reimbursement
  • Annual Bonus Eligibility
Valencia Technologies is proud to be an equal opportunity workplace and is an affirmative action employer

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