Manufacturing Engineer II, Capital Equipment

Imperative Care; Campbell (CA); On-site; USD 102,000 - 120,000; Full time

Benefits offered by this job

Stock options

Bonus

Competitive salaries

401k plan

Health benefits

Generous PTO

Parental leave program

Emotional health resources

Job summary

Imperative Care in Campbell, California is seeking a Manufacturing Engineer II to join our on-site team. You will drive manufacturability, support tech transfer from design to production, and enable scalable manufacturing of complex electromechanical capital equipment.

Ideal candidates have a Bachelor’s degree in Engineering and 2+ years of related experience, with knowledge of QA/regulatory systems and strong communication and project-management skills.

Qualifications

• Bachelor's degree in Engineering or related discipline; 2+ years of related experience.
• Knowledge of and exposure to product testing and data collection.
• Excellent communication skills (written and verbal).
• Experience with quality systems (FDA QSR, ISO 13485, MDD).
• Experience in pilot/production line setup and validation in a controlled environment preferred.
• Familiarity with GMP, GDP procedures and requirements.
• Ability to work independently or in a team; strong project management is valued.

Responsibilities

• Assist in prototyping for new products or enhancements.
• Support in-house manufacturing to verify conformance to plans and regulatory requirements.
• Coordinate with Supply Chain for material availability and inventory control.
• Develop MPI/LHR/DHR documents in collaboration with R&D and Quality.
• Conduct time studies and drive process development initiatives.
• Define in-process inspections and testing with Quality to resolve issues.
• Coordinate cross-functional teams from concept to clinical testing.
• Maintain and monitor manufacturing tasks against project timelines and budgets.
• Participate in manufacturing meetings and foster team relationships.
• Coordinate tooling/equipment needs for cost-effective manufacturing.
• Facilitate smooth tech transfer from design to manufacturing.

Skills

Engineering degree

Product testing

Data collection

Excellent communications

Regulatory quality systems

Pilot/production line setup

GMP/GDP knowledge

Independent or team work

Project management

Education

Bachelor's degree in Engineering

Job description

Manufacturing Engineer II, Capital

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 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.

• Assist in the construction of prototypes for new products/processes or current product enhancements.


• Provide support to in-house manufacturing activities to verify products are manufactured in accordance with product plans and quality/regulatory requirements.


• Work with Supply Chain to verify inventory of raw materials and components are available per the planned build schedule, monitor and be accountable for material issued to production/projects.


• 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


• Conduct time studies for each manufacturing process and identify process development initiatives


• Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects


• Inform and coordinate with multi-functional operations project team activities from early project conceptualization through clinical testing


• Complete, maintain, and monitor manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met


• Participate in manufacturing team meetings to ensure communication between members


• Build positive proactive working relationships with team members and other staff members


• Complete 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


• Work with R&D staff to facilitate smooth transition of products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and Company requirements.


• Collaborate with suppliers to ensure parts/services are properly documented and meet specifications


• Review specifications for sub and final assemblies


• Support manufacturing line and approve DCO’s for manufacturing engineering


• Support the training/certification of the MPI Trainer for manufacturing process instructions; may train other staff as needed


• Using continuous improvement techniques, work with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability

What You’ll Bring

• Bachelor’s degree in Engineering or related discipline and min 2 years of related experience; or equivalent combination of education and work experience.


• Knowledge of and exposure to product testing and data collection


• Excellent communications skills (both written and verbal) required


• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD


• Experience in pilot/production line set-up, validation in a controlled environment is preferred.


• Familiar with GMP, GDP procedures and requirements


• Ability to work independently or in team setting required


• Project management experience preferred

Employee Benefits

• stock options


• bonus


• competitive salaries


• 401k plan


• health benefits


• generous PTO


• parental leave program


• emotional health resources

Join Us!

Salary Range: $ 102,000 - $120,000 / 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 use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.