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Imperative Care Sr Manager, Manufacturing Engineering in Campbell, California

Job Title: Senior Manager, Manufacturing Engineering

Location : This position is based in our Campbell, California offices. This position is on-site 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

The Senior Manager, Manufacturing Engineering oversees a team of engineers responsible for activities related to the successful transition from R&D pilot production to manufacturing and continued through sustained commercialization. This position works on the development and continuous improvement implementation of production processes, systems and equipment needed to meet the manufacturability of, and the improving quality and cost reduction of, company products. This position ensures that all products are developed and manufactured in compliance with validation protocols, company Quality System, budgetary requirements and regulatory requirements of countries where products will be marketed. 

  • Coach a team of engineers in developing technical skills to assess manufacturing capabilities and define proper design transfer requirements to reduce waste and establish smooth and effective processes.

  • Manage, develop and engage a group of manufacturing engineers to meet projects goals and objectives while striving for a significant and measurable business impact in a quality driven team-based manufacturing environment.

  • Lead initiatives to achieve manufacturing KPI goals in safety, quality, delivery, inventory and cost.

  • Identify cost improvements through design, process development, and manufacturing strategies, and lead teams in the implementation of these improvements.

  • Work with operations leaders to implement and execute strategic project management plans, set priorities and timelines and achieve company goals for commercialization and production of stable products .

  • Collaborate with Operations, R&D, Quality and other cross-functional stakeholders to understand product development and business needs to establish manufacturing processes that meet those needs.

  • Evaluate and recommend changes needed to ensure manufacturability of products in accordance with design specifications, Quality Systems, Operator ability and within cost requirements.

  • Determine most effective use of resources to drive GMP, lean principles and quality concepts across the business and with contractors. Participate in the research, evaluation and implementation of contract manufacturing programs that meet design, budget requirements and quality systems standards.

  • 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.

  • 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.

    What You’ll Bring

  • BS/MS in Mechanical, Manufacturing or Industrial Engineering or related discipline; and 8+ years of experience in this field with progressive experience in managing a team in a medical device or related industry; or an equivalent combination of education and experience.

  • Lean Six Sigma Black Belt preferred.

  • 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, preferred.

  • Demonstrated ability in problem solving and strong understanding of GMPs

  • Solid experience with MS Project or other planning tools.

  • Strong interpersonal skills and engaging leadership skills for managing teams.

  • Experience with the development of budgets, project plans, etc., and ability to prioritize multiple tasks.

    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.

Salary Range:  $186,000 – 200,000 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.

Join Us! Imperative Care (https://imperativecare.com/careers/)

 

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