Sr Process Development Engineer

Imperative Care•Campbell, CA

3d•$125,000 - $136,000•Onsite

About The Position

As a senior professional in this field, this position will contribute to product development projects by defining, characterizing, optimizing, and validating stable, robust, and capable processes for neuro-interventional medical devices. This role will develop and improve internal equipment and manufacturing processes including qualification of processes at external suppliers/contract manufacturers sites. This position uses demonstrated experience to contribute to design process characterization studies by analyzing, interpreting and documenting/reporting data, and documenting effectiveness of equipment/processes. Prepare and implement improvements to the design, selection, characterization, optimization, validation, documentation, and control all manufacturing processes. Define and measure critical process parameters (CPP) that impact critical quality attributes (CQA) of a product, along with cross-functional teams. Spearhead the development and improvement of new/existing processes. Initiate innovation by identifying and selecting new process technologies including defining, developing, and qualifying new equipment/fixtures or improving existing equipment/ fixtures. Identify and recommend solutions to improve performance by employing analytical techniques and engineering principles to understand impact/interaction of materials and processes on outputs. Develop with a cross-functional team process windows, manufacturing control limits, manufacturing workflows, effectively monitoring control plans, lot history records and workmanship standards. Define manufacturable product design specifications and visual standards. Design, execute, test, and analyze results from DOEs providing guidance/insights to collaborating team. Plan and make data-driven decisions by applying DMAIC principles to find root cause/solve problems. Document equipment and process performance and compliance. Participate in overseeing and qualifying external suppliers

Requirements

Bachelor’s degree in engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry.
Ability to perform computer modelling simulations on material, process & properties.
Experience in pilot and production line set-up, validation and scale-up in a controlled environment.
Experience with GMP, GDP procedures and requirements.
Excellent analytical and statistical skills (SPC, DOEs) using Excel, Minitab &/or JMP.
Excellent knowledge of and experience in FDA Design Control procedures and DFSS/DFM tools.
Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards.
Excellent project management and communications skills (both written and verbal).
Exceptional critical thinking – able to intuitively identify problems, logically and empirically associate cause and effect, and under a variety of perspectives and constraints, prioritise and provide creative, effective, and practical solutions.
Ability to work independently and influence others in team setting with/without authority.
Able to share knowledge and mentor/guide others in work related to this filed.
Ability to travel – as required.

Nice To Haves

Working knowledge of Agile scrum framework, a plus.

Responsibilities

defining, characterizing, optimizing, and validating stable, robust, and capable processes for neuro-interventional medical devices
developing and improving internal equipment and manufacturing processes including qualification of processes at external suppliers/contract manufacturers sites
contributing to design process characterization studies by analyzing, interpreting and documenting/reporting data, and documenting effectiveness of equipment/processes
preparing and implementing improvements to the design, selection, characterization, optimization, validation, documentation, and control all manufacturing processes
defining and measuring critical process parameters (CPP) that impact critical quality attributes (CQA) of a product, along with cross-functional teams
spearheading the development and improvement of new/existing processes
initiating innovation by identifying and selecting new process technologies including defining, developing, and qualifying new equipment/fixtures or improving existing equipment/ fixtures
identifying and recommending solutions to improve performance by employing analytical techniques and engineering principles to understand impact/interaction of materials and processes on outputs
developing with a cross-functional team process windows, manufacturing control limits, manufacturing workflows, effectively monitoring control plans, lot history records and workmanship standards
defining manufacturable product design specifications and visual standards
designing, executing, testing, and analyzing results from DOEs providing guidance/insights to collaborating team
planning and making data-driven decisions by applying DMAIC principles to find root cause/solve problems
documenting equipment and process performance and compliance
participating in overseeing and qualifying external suppliers