Process Development Engineer I

Location: Campbell, CA

Department: Process Development

• 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.

• 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.

• Professional experience in the medical device industry is preferred.
• 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).
• 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.
• Familiar with GMP, GDP procedures and requirements.

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.