Job Information
Imperative Care Sr Manufacturing Engineer in Campbell, California
Sr Manufacturing Engineer
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?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
Th is position is 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. This position 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.
Manufacturing Operations Management: Establish and oversee in-house and contract manufacturing activities, ensuring compliance with product plans, quality, and regulatory requirements. Collaborate with Supply Chain, R&D, and Quality teams to manage materials, specifications, and smooth product transitions to manufacturing.
Process Development and Validation: Develop and document manufacturing processes, instructions (MPI), Lot History Records (LHR) and validations (IQ/OQ/PQ). Identify tooling and equipment needs, create workflows, and conduct time studies to optimize efficiency and cost-effectiveness.
Quality and Continuous Improvement: Partner with Quality to define in-process inspections, resolve quality/yield issues, and implement continuous improvement initiatives to enhance product reliability, reduce costs, and support the Quality Management System.
Cross-Functional Collaboration: Coordinate and communicate with cross-functional teams (R&D, Engineering, Quality, Production) to manage project schedules, meet critical timelines, and ensure effective execution of tasks.
Manufacturing Transfer and Insourcing: Manage the transition of products from development to production, including insourcing assembly lines, defining equipment needs, and establishing manufacturing processes to meet cost, quality, and regulatory targets.
Training and Oversight: Train and certify personnel on manufacturing processes, promote adherence to GMPs, FDA, and regulatory requirements, and support management reviews and quality objectives
What You’ll Bring – minimum requirements for this role:
BS in Engineering or related discipline and 5+ years of related experience (MS in Engineering preferred).
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.
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! Imperative Care (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. 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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