Sr Manufacturing Engineer, Capital Equipment

imperativecare; Campbell (CA); On-site; USD 125,000 - 145,000; Full time

Benefits offered by this job

401k plan

Health benefits

Generous PTO

Parental leave program

Job summary

Imperative Care in Campbell, CA, is seeking a Sr Manufacturing Engineer for capital equipment to lead in-house manufacturing activities and drive technology transfer from design to scalable production. This on-site, full-time role collaborates with R&D, Quality, and Supply Chain to ensure compliant, efficient production of complex electromechanical capital equipment.

Ideal candidates will have a BS in engineering with 5+ years in regulated medical device industries, and experience with GMP/GDP,

Qualifications

• BS in Engineering or related discipline with 5+ years in medical device or regulated industry.
• Experience setting up pilot/production lines and validating in controlled environments.
• Familiar with FDA QSR, ISO 13485, ISO 9001, and MDD regulatory frameworks.
• Experience with surgical robotics or complex electromechanical capital equipment preferred.
• Knowledge of GMP and GDP procedures and working independently or in teams.

Responsibilities

• Execute in-house and contract manufacturing activities meeting plans and quality/regulatory requirements.
• Collaborate with Supply Chain to ensure material availability for builds.
• Develop MPI/Manufacturing processes and LHRs with R&D and Quality.
• Create manufacturing specifications and coordinate IQ/OQ/PQ validations.
• Train MPI staff and plan equipment/workflow layouts; manage calibration and maintenance.

Skills

Pilot/production line setup

Validation

Independent/teamwork

Education

BS in Engineering or related discipline

Tools

FDA QSR

ISO 13485

ISO 9001

Job description

Title: Sr Manufacturing Engineer, Capital Equipment

This position is based in our Campbell, California offices. This position is on-site & full-time

Why Imperative Care?

At Imperative Care, we are developing novel robotic-assisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke – a disease that impacts close to a million people a year in the U.S., and 10 million worldwide. Not only is Imperative Care Robotics changing the way stroke is treated, but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease – a disease in which one in four adults will face in their lifetime.

What You’ll Do

An individual in this role uses strong hands‑on experience to execute and deliver assigned projects/products to ensure manufacturability, supporting technology transfer from design to manufacturing and ultimately scalability for commercialization for complex electromechanical capital equipment. This position will complete projects related to in‑house manufacturing, manufacturing engineering, and equipment planning/engineering in accordance the company’s Quality System and customer requirements.

• Execute in-house and/or contract manufacturing activities and build relationships that ensure products are manufactured adhering to plans and quality/regulatory requirements.
• Work with Supply Chain to ensure inventory of raw materials and components are available per planned build schedule, lead and be accountable for material issued to production/projects.
• Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) in collaboration with R&D and Quality.
• Develop manufacturing specifications for products; coordinate all process validation activities with Quality- IQ/OQ/PQ.
• Train/Certify MPI Trainer for manufacturing process instructions; may train other staff as needed. Plan equipment and workflow layouts in manufacturing areas. Manage manufacturing equipment design and development to ensure that equipment is cost effective and meets manufacturing specifications and maintain and coordinate all calibration and preventive maintenance activities in conformance with the Company’s Quality System requirements.

What You’ll Bring:

• BS in Engineering or related discipline and 5+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
• 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, ISO 9001, and the MDD.
• Experience with surgical robotics or other complex electromechanical capital equipment is highly desired
• Familiar with GMP, GDP procedures and requirements
• Ability to work independently or in team setting required

Employee Benefits

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, bonus, health benefits, generous PTO, and a parental leave program.

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.

Salary Range: $125,000 – 145,000 /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.

The posted salary range reflects compensation for employees based in the local Bay Area market. For candidates hired outside of this geographic area, compensation may vary and be adjusted based on location, local market conditions, and other factors