Sr Process Development Engineer

About the role

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.

Responsibilities

• 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.
• Working knowledge of Agile scrum framework, a plus.
• Able 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.
• Able to travel – as required.

Qualifications

• Experience with neuro-interventional medical devices.
• Experience with process development and optimization.
• Experience with process validation and qualification.
• Experience with GMP and GDP procedures.
• Experience with statistical analysis and process modeling.
• Experience with FDA Design Control procedures and DFSS/DFM tools.
• Experience with quality system compliance.
• Experience with project management and team collaboration.
• Experience with process window definition and control.
• Experience with equipment and fixture development and qualification.
• Experience with data-driven decision making and problem solving.

Skills

• Computer modelling simulations on material, process & properties.
• Process development and optimization.
• Process validation and qualification.
• GMP and GDP procedures.
• Statistical analysis and process modeling.
• FDA Design Control procedures and DFSS/DFM tools.
• Quality system compliance.
• Project management and team collaboration.
• Process window definition and control.
• Equipment and fixture development and qualification.
• Data-driven decision making and problem solving.

Benefits

• Employee stock options.
• Competitive salaries.
• 401(k) plan.
• Health benefits.
• Generous paid time off.
• Parental leave program.

Pay

$125,000 – 136,000 annually

Schedule

Full-time and on-site in Campbell, CA