Job Information
Imperative Care Sr Manufacturing Engineer in Campbell, California
Job Title: Sr Manufacturing Engineer
Location : This position is based in our Campbell, California offices. This position is on-site and full-time with some travel.
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
As a Sr Manufacturing Engineer, you will be responsible for the following areas: In-House and Contracted Manufacturing, Manufacturing Engineering, and Equipment Planning/Engineering in accordance the company’s Quality System and customer requirements. You will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and ultimately scalability for commercialization.
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 Manufacturing Process Instructions (MPI’s) and lot history records (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.
Develop manufacturing specifications for products; coordinate all process validation activities with Quality- IQ/OQ/PQ.
Determine tooling and equipment needs for the timely and cost-effective manufacture of products
What You’ll Bring
BS in Engineering or related discipline and 5+ years of related experience; or MS in Engineering with 3+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
Knowledge of and experience in pilot/production line set up and validation in Controlled Environment.
Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
Familiar with GMP, GDP procedures and requirements..
Must be able to travel.
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! Apply Today (https://imperativecare.com/careers/)
Salary Range: $119,000 – 130,000 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.
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