Imperative Care
Sr Manufacturing Engineer Job at Imperative Care in Campbell
Imperative Care, Campbell, CA, United States
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.
What You'll Bring
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
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.
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
- 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.
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
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.