Shire Jobs

Title: Manufacturing Engineer I

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

As a new professional in this field, this position will use acquired professional education and/or experience in mechanical, electrical, and/or pneumatic systems to focus on supporting activities related to the equipment used for manufacturing our company products.  An individual in this role will be involved in drafting equipment installation/operation qualifications.  This role will participate in the analysis of design studies to determine equipment capabilities, programs and solutions for increasing uptime that affect manufacturing processes.   This hands-on engineering position will resolve issues related to calibration, preventive maintenance, and equipment repairs in accordance with maintenance schedules, manufacturer specifications, technical notices, equipment upgrades and safety issues. This position will address equipment related nonconformances and lead corrective and preventive actions.

•    Assist with the verification of equipment calibration and preventive maintenance activities using Blue Mountain Regulatory Asset Manager (RAM) software. 

•    Assist with ensuring that all manufacturing equipment is installed, qualified, validated, and maintained in compliance manufacturer specifications and company quality systems and regulatory requirements. 

•    Maintain current records using technical writing skills to draft the following documents: equipment requirement specifications, equipment installation and operation qualification protocols, equipment calibration, maintenance procedures and standard operating procedures. 

•    Track efficiency of current procedures and equipment performance to identify areas of improvement.   

•    Support calibration and maintenance methods and recommend solutions/improvements to maintain the safe and reliable operation and uptime of equipment.

•    Address equipment related nonconformances (NCRs), draft NCRs and assist with equipment related corrective and preventive actions (CAPAs).  

•    In collaboration with R&D, Quality and other Manufacturing Engineers, participate in the development and implementation of multiple project plans and timelines where equipment selection and proper design may affect manufacturing processes, development initiatives, in-process inspections and quality testing for continuous improvement projects.

•    Support Manager with initiating recommendations on purchase of new equipment and improvements to plant property.

•    Organize equipment spares and create/maintain a stocking system of spare parts in collaboration with purchasing and other manufacturing support team members. Monitor maintenance costs.

•    Participate in manufacturing team meetings to ensure communication between members

What You’ll Bring – minimum requirements for this role:

•    Bachelor’s degree in engineering or related discipline and less than 2 years of any professional experience; or equivalent combination of education and experience.

•    Exposure to product testing, data collection, or basic knowledge of medical device industry is preferred. 

•    Knowledge or experience working within an FDA or ISO 13485 regulated environment using GDP and GMP practices is desired.

•    Some previous equipment maintenance experience preferred. 

•    Ability to read and interpret manuals, assembly drawings, electrical and system schematics.

•    Knowledge of mechanical alignment and troubleshooting of electromechanical systems, pneumatic systems, electrical/electronic components, optics, sensors, optics, motors, and PLCs is preferred.

•    Ability to perform critical thinking to identify problems and logically and empirically associate cause and effect while considering a variety of perspectives and constraints to prioritize and provide creative, effective and practical solutions. 

•    Ability to troubleshoot problems and assess whether equipment and/or parts can be repaired or need to be replaced. 

•    Ability to design equipment and fixtures using CAD/SolidWorks, and review/create detailed prints.

•    Analytical and statistical skills (SPC) using Excel, Minitab and/or JMP.

•    Ability to work independently or in a team setting

•    Strong communications skills (both written and verbal) and ability to learn the management of outside equipment services.

•    Ability to detail project plans effectively is preferred.

. 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: $84,000 – 89,000 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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