Imperative Care · 7 hours ago
Staff Manufacturing Engineer, Capital Equipment
Campbell, CA
Full-time
Onsite
Lead/Staff
$147K/yr - $167K/yr
8+ years expImperative Care is developing novel robotic-assisted technologies aimed at changing the treatment outcomes of ischemic stroke. The Staff Manufacturing Engineer will be responsible for overseeing manufacturing processes, managing production activities, and ensuring compliance with quality and regulatory requirements.
Health CareMedicalMedical Device
Responsibilities
Oversee the builds for capital hardware and equipment
Manage in-house and contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements
Ensure Supply Chain is aware of inventory, raw materials, and component requirements per the planned build schedule; manage and be accountable for material issued to production or engineering projects
Conceptualize and implement manufacturing improvements, tooling, and systems to increase productivity and/or improve yields
Define manufacturing or process related technologies to reduce manual operations and/or improve repeatability
Participate in the selection of suppliers for manufacturing components
Work closely with Quality to create manufacturing and process related SOPs and Wis
Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) or Device History record (DHR’s) in collaboration with R&D and Quality
Perform time studies for each manufacturing process and identify process development initiatives
Ensure that all products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements
Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects
Qualification
Required
BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 8+ 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, the MDD, and knowledge of relevant standards
Ability to detail project plans effectively
Familiar with GMP, GDP procedures and requirements
Familiar with Design Control procedures and requirements
Excellent communications skills (both written and verbal) required
Ability to work independently or in team setting required
Working knowledge of quality system requirements and compliance (e.g. traceability, QSRs, ISO, MDD/MDR requirements) and other applicable regulations
Experience working with ERP/MRP/Documentation control systems
Preferred
Project management experience preferred
Benefits
Stock options
Bonus
Competitive salaries
A 401k plan
Health benefits
Generous PTO
Parental leave program
Emotional health resources
Company
Imperative Care
Imperative Care is singularly dedicated to finding meaningful answers to unsolved problems in stroke.
201-500 employees
H1B Sponsorship
Imperative Care has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (3)
2023 (5)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$558.97MKey Investors
Ally Bridge GroupD1 Capital Partners
2024-07-25Series E· $150M
2021-07-15Series D· $260M
2021-01-01Debt Financing· $40M
Leadership Team
Lara Abbaschian
Senior Director, R&D
Recent News
BioWorld Financial Watch
2025-09-24
Company data provided by crunchbase