Process Development Engineer I

Imperative Care•Campbell, CA

3d•$90,000 - $95,000•Onsite

About The Position

As a new professional in this field, a Process Development Engineer I will participate in defining, characterizing, optimizing, and validating processes for product development of intravascular medical devices. This role will use basic professional knowledge, critical thinking, and creative problem-solving skills to assist in improving internal equipment, applying engineering principles, conducting process studies, analyzing project data, and documenting equipment/processes. Assist cross-functional teams in designing, characterizing, optimizing, documenting, and controlling all manufacturing processes through the definition and measurement of critical process parameters (CPP) which impact critical quality attributes (CQA) of the product. Participate in Design of Experiments (DOEs) and DMAIC projects to help design, execute, test, analyse, problem-solve and find root cause when evaluating changes/improvements to a process or design. Collaborate effectively and work independently to complete tasks after receiving detailed instructions. Support teams that create process windows, manufacturing control limits, and workmanship standards. Participate in projects to define manufacturable product design specifications and visual standards. Monitor equipment and documentation processes. Build relationships with cross functional teams that develop manufacturing workflows, monitor control plans effectivity and lot history records. Maintain professional knowledge of analytical techniques and engineering principles applications to collect and analyze data and understand the impact and interaction of materials and processes, on process and product outputs.

Requirements

Bachelor’s degree in engineering or related field, and less than 2 years of any other professional experience; or equivalent combination of education and work experience.
Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP.
Ability to identify problems, logically and empirically, and associate cause-effect relationships under a variety of perspectives and constraints.
Ability to prioritise and provide creative, effective and practical solutions.
Strong communications skills (both written and verbal).
Familiar with GMP, GDP procedures and requirements.

Nice To Haves

Professional experience in the medical device industry is preferred.
Experience in pilot/production line set-up, validation in a controlled environment is preferred.
Knowledge of quality systems design to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards is desired.
Basic knowledge or experience with FDA Design Control procedures and DFSS/DFM tools a plus.
Ability to perform computer modelling simulations on material, process & properties a plus.

Responsibilities

Defining, characterizing, optimizing, and validating processes for product development of intravascular medical devices.
Improving internal equipment, applying engineering principles, conducting process studies, analyzing project data, and documenting equipment/processes.
Assisting cross-functional teams in designing, characterizing, optimizing, documenting, and controlling all manufacturing processes through the definition and measurement of critical process parameters (CPP) which impact critical quality attributes (CQA) of the product.
Participating in Design of Experiments (DOEs) and DMAIC projects to help design, execute, test, analyse, problem-solve and find root cause when evaluating changes/improvements to a process or design.
Collaborating effectively and work independently to complete tasks after receiving detailed instructions.
Supporting teams that create process windows, manufacturing control limits, and workmanship standards.
Participating in projects to define manufacturable product design specifications and visual standards.
Monitoring equipment and documentation processes.
Building relationships with cross functional teams that develop manufacturing workflows, monitor control plans effectivity and lot history records.
Maintaining professional knowledge of analytical techniques and engineering principles applications to collect and analyze data and understand the impact and interaction of materials and processes, on process and product outputs.