Director Manufacturing Engineering

Campbell, CA
Full Time
Operations
Senior Manager/Supervisor
Director Manufacturing Engineering
Location: This position is based in our Campbell, California offices. This position is onsite and full time

Why Imperative Care?
Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.

What You’ll Do
Responsible for technical transition of products from R&D to manufacturing and through commercialization.  Responsible for strategic overview in the following areas:  Manufacturing Engineering, R&D Pilot Production and Equipment Planning.  Work on development and implementation of production Process Equipment and systems for company products. Ensure that all products are developed and manufactured in compliance with the company Quality System, budgetary requirements and the regulatory requirements of the countries into which the products will be marketed. 
  • Collaborate with cross-functional stakeholders to understand product development and business needs and establish manufacturing processes which best fit those needs
  • Work directly with R&D and Process Engineering, Production and Quality Assurance staff to ensure the manufacturability of products in accordance with design specifications, Quality Systems, Operator ability and within cost requirements.
  • Partner with R&D management and cross-functional product teams on new product development, pilot operations, manufacturing capabilities and design transfer to ensure smooth and effective processes.
  • Determine most effective use of contract manufacturing.  Through staff, research, evaluate, negotiate, and implement contract manufacturing (domestic and/or overseas) programs to ensure timely and cost-effective production of products in accordance with design and budget requirements and quality systems requirements
  • Direct the day-to-day operations of Manufacturing Engineering, Pilot Production, etc.  Ensure that all policies and practices are in conformance with company philosophy and legal requirements
  • Working with senior management and staff, develop and implement comprehensive timelines and project management plans, and monitor their execution to achieve company goals for commercialization and production of stable product(s)
  • Consider long-term sustainability and scalability in all manufacturing-related decisions
  • Provide proactive management, coaching, and leadership to staff, including team building and mentoring
  • Establish project timelines and staffing needs based on approved product development programs  
  • Recruit and retain a team of employees whose skills meet the needs of the organization and who are engaged in the goals of the company
  • Ensure all company products are designed, developed, tested, manufactured, and documented in accordance with regulatory requirements for approval of products by US and foreign regulatory agencies
  • Determine budgets for tooling and equipment needs for the timely and cost-effective manufacture of products
  • Manage the development and implementation of engineering specifications for products scheduled for release to Production in accordance with quality system and regulatory requirements
  • In conjunction with VP Operations and/or CFO, determine departmental budgets.  May provide assistance in the development of financial modeling for new opportunities
  • Identify cost improvements through design, process development, and manufacturing strategies.

What You’ll Bring
  • Bachelor’s degree and a minimum of 10 years of Engineering, Industrial Engineering or medical device related experience preferred; or equivalent combination of education and work experience.
  • Minimum of 3 years direct supervisory/managerial experience
  • Experience working in compliance with Quality Systems designed to meet regulatory requirements, such as but not limited to FDA QSR ISO 13485, MDD etc. 
  • Previous experience managing outside contract manufacturers
  • Solid experience with MS Project or other planning tools 
  • Strong and engaging leadership skills for managing teams
  • Previous experience with the development of budgets, project plans, etc.
  • Excellent communications skills (both written and verbal) required
  • Excellent presentation skills are required
  • Ability to work independently or in team setting required
  • Must be able to travel domestically and internationally
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Join Us! Imperative Care

Salary Range: $217,000 – 226,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.  As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources

 
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