Process Engineering Manager

San Jose, CA /
Manufacturing – Manufacturing/Engineering Team /
Full Time
/ On-site
The Manager of Process Engineering is responsible for providing technical leadership and direction to a team of talented engineers. The successful candidate will have extensive experience in the areas of process development/optimization, continuous improvement, and cost reduction as well as verification & validation activities in a fast-paced environment. 
This is a hands-on position that requires interaction and collaboration with cross-functional teams including R&D Engineering, Automation Engineering, Manufacturing, Material, Quality, and safety. 

Requirements

    •  Develop standards and key performance metrics to reduce variability as well as improving quality, throughput, and efficiency 
    • Actively participate in early design concept reviews with R&D and Automation Engineering and provide objective feedback to ensure manufacturing robustness
    • Perform equipment characterization and define process windows by creating appropriate DOE’s and utilizing statistical data analysis
    • Own the verification/validation activities including generation of IQ/OQ/PQ protocols, execution and final reports as well as creating SOP’s, MPI’s LHR’s and providing appropriate training
    • Recommend production layouts for automation equipment and material flow for maximum efficiency
    • Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution
    • Provide support for existing equipment and ensure proper documentation and training
    • Lead new product transfer and manufacturing scale-up activities utilizing best manufacturing techniques
    • Champion and foster a mindset of quality and continuous improvement 
    • Adhere to project timelines, identify risks/issues, and recommend mitigations
    • Attract/hire top talent and ensure retention by providing coaching/mentoring and encouraging career growth 
    • Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Education and/or Job Experience

    • Bachelor's Degree in Chemical, Mechanical, Manufacturing, or related engineering fields
    • 5-7 years hands-on experience in the medical device field with proven track record of process development/optimization and validation
    • Minimum 3 years of proven leadership and people management
    • Excellent verbal, written, presentation and interpersonal skills
    • Prior experience with FDA regulations and ISO, cGMP, QMS standards
    • Strong analytical and problem-solving skills including but not limited to DOE and statistical data analysis
    • Extensive experience with process capability studies, FMEA, GR&R, SPC and process development/validation
    • Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines/processes
    • Knowledge of material science and polymer chemistry
    • Experience with Statistical Software tools such as Minitab or JMP
    • Experience with Lean manufacturing 

Preferred Qualifications

    • Advanced engineering degree
    • Familiarity with aseptic manufacturing
    • Project management experience 
    • Knowledge and experience in plastics assembly techniques
Salary Range: $155,616 - $167,400

Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law.

Our organization's commitment to Diversity, Equity, and Inclusion is key to making us a better team - one that makes better decisions, drives innovation, and delivers better business results. At Rani Therapeutics, we're committed to a workplace culture where everyone feels comfortable to bring their authentic selves. We pledge to foster inclusion in our organization by promoting psychological safety, embracing differences, and being accountable for our actions. We strive to make Rani a place where each individual feels seen and empowered to reach their highest potential.

Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.