Manufacturing Engineering Lead

2 weeks ago

Campbell, California, United States Imperative Care Full time
About Imperative Care

We're changing the way stroke is treated by developing breakthroughs that will revolutionize the future of stroke care. Our focus is on the needs of the patient, and they come first in everything we do.


Salary Information

The estimated salary range for this position is $119,000 - 130,000 annually.


Job Description

This Sr Manufacturing Engineer role involves responsibility for in-house and contracted manufacturing activities, including establishing relationships with suppliers, ensuring product quality, and managing project timelines. The ideal candidate will have a bachelor's degree in engineering or a related field and at least 5+ years of experience in pilot/production line setup and validation.


Key Responsibilities
  • Establish and manage in-house and/or contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements.
  • Develop manufacturing processes and MPI's and LHR's in collaboration with R&D and Quality.
  • Lead the construction of prototypes for new products/processes or current product enhancements. And perform time studies for each manufacturing process and identify process development initiatives.
  • Provide oversight and coordinate multi-functional operations project team activities from early project conceptualization through clinical testing.
  • Create, maintain, and manage manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met.
  • Determine tooling and equipment needs for the timely and cost-effective manufacture of products.

Requirements and Qualifications
  • Bachelor's degree in engineering, or related discipline and a minimum of 5+ years of related experience; or equivalent combination of education and work experience.
  • Demonstrated knowledge and experience in pilot/production line set up and validation in controlled environment, including work under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
  • Ability to detail project plans effectively.
  • Familiar with GMP, GDP procedures and requirements.
  • Excellent communications skills (both written and verbal) required.
  • Ability to work independently or in team setting required.
  • Project management experience preferred.
  • Must be able to travel.

Benefits

Our benefits package includes stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

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