Staff Manufacturing Engineer
Company: PROCEPT BioRobotics
Location: Redwood City
Posted on: February 19, 2021
PROCEPT BioRobotics is a surgical robotics company enabling
better patient care by developing transformative solutions in
urology. With an initial focus on BPH, the company's AquaBeam--
Robotic System delivering Aquablation therapy, is the first
FDA-cleared, automated surgical robot for the treatment of lower
urinary tract symptoms (LUTS) due to benign prostatic hyperplasia
(BPH). Aquablation therapy combines real-time, multi-dimensional
imaging, automated robotics and heat-free waterjet ablation for
targeted, controlled, and immediate removal of prostate tissue.
Aquablation therapy offers predictable and reproducible outcomes,
independent of prostate anatomy, prostate size or surgeon
As we continue to grow and streamline our manufacturing operations,
PROCEPT now needs to hire a Staff Manufacturing Engineer who can
bring their hands-on and project management expertise as well as
their extensive capital equipment know-how to the company. The new
Engineer will take ownership of key internal and contract
manufacturing processes. The new hire will bring strong continuous
improvement and leadership competencies to drive quality, delivery,
and cost improvements in manufacturing and this will include
reviews of current capabilities and establishing new processes.
She/He will also partner with the R&D and Process Development
teams to transfer manufacturing processes into production.
CORE RESPONSIBILITIES (Other Duties May Be Required As
- Lead engineering support to manufacturing and resolve issues
impacting production fulfillment (e.g. troubleshoot existing
manufacturing processes, fixtures, tooling or equipment).
- Champion continuous improvement by identifying projects to
create and support best in class lean manufacturing systems to
maximize yield, capacity, and capability.
- Identify, justify and implement multiple significant data
driven projects to reduce manufacturing costs, improve processes,
increase product reliability, and enhance process capability.
- Develop and enable data driven operational and financial
decisions through predictive insights into tool and process
- Generate and execute business improvement ideas for cost
reduction, labor savings, material flow and safety.
- Design and evaluate new and existing fixtures and equipment,
test methods, specifications, layouts, and standards.
- Identify and recommend manufacturing technologies to
strategically develop business objectives and potential
- Responsible for process documentation and ensuring it is kept
current like Manufacturing Instructions, Standard works documents,
PFMEA, standard works and Control Plans.
- Work with R&D and Process Development teams to transfer new
products into commercial manufacturing, both in-house and at
- Identify, define and execute new technical projects that
improve manufacturing processes - this will include developing the
scale, scope and ROI.
- Design, build or procure improved fixtures, tooling or
equipment to increase quality, reliability, capacity, and
- Provide floor layouts for areas associated with manufacturing
- Write test protocols, preform tests to fully characterize new
equipment or processes utilizing DOE methodology or other
statistically sound methods, then write completion reports.
- Perform process capability assessments and establish methods to
control process output.
- Create process validation protocols, conduct process
optimization studies, conduct process verifications and
validations, and generate verification and validation reports.
- Write and perform IQ's, OQ's and PQ's when introducing new or
changing existing manufacturing equipment.
- Provide engineering support to outside suppliers and contract
manufacturers, ensuring quality and production targets are
- Train, develop, and/or provide work direction to operators and
- May require up to 20% travel, domestic and international.
- Maintain trained status for, and comply with, all relevant
aspects of the PROCEPT BioRobotics Quality Management System to
ensure product and support regulatory compliance.
- Understand and adhere to the PROCEPT BioRobotics Quality
- Understand and adhere to the PROCEPT BioRobotics EHS
QUALIFICATIONS (Education, Experience, Certifications)
To perform this job successfully, an individual must be able to
perform each essential duty satisfactorily. The requirements listed
below are representative of the knowledge, skill, and/or ability
required. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential
- BS in an Engineering discipline such as mechanical or
electrical engineering with a minimum of 8 years' experience or an
MS in Engineering with a minimum of 6 years' experience.
- Experience supporting medical device manufacturing.
- Experience in leading highly technical projects in a cross
functional environment both internally and with CMOs/Vendors.
- Extensive experience with root cause analysis and problem
solving for both technical and process issues.
- Preferred experience with Lean and Six Sigma tools.
- Experience working in a structured design process such as
ISO9000 or FDA QSR, knowledge of regulatory approval process and
- Working knowledge of design control and cGMP requirements for
medical device manufacturing per FDA QSR and ISO13 or ISO9001and
- Basic working knowledge of CAD (Solidworks or other)
- Excellent computer skills with specific skills in Microsoft
Office and proficient in SolidWorks.
May include the technical supervision of Manufacturing Engineer(s)
and/or Manufacturing Engineering Technician(s).
Keywords: PROCEPT BioRobotics, Redwood City , Staff Manufacturing Engineer, Engineering , Redwood City, California
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