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MANUFACTURING PROCESS ENGINEER - SAN JOSE, CALIFORNIA

06/01/2023

We are currently looking for a Manufacturing Process Engineer that will be supporting the manufacturing team with one of our clients. The ideal candidate will be working with engineering and clinical to ensure device specifications conform to device requirements. Responsible for establishing baseline by evaluating the current manufacturing processes and making improvements to increase productivity, quality /reliability, and reduce cost and scrap

Requirements

Evaluate the current manufacturing processes /workflows to identify opportunities for improving productivity and quality while reducing cost /labor
Perform process capability studies via DOE’s. Utilize statistical data analysis to arrive at sound conclusions and follow up with action plan for process improvements
Develop standards and monitoring techniques to reduce variability in manufacturing that may include operator, material, equipment and processes
Actively participate in discussions with appropriate functions and contribute to new initiatives that may include design, manufacturing, process /quality improvement as well as cost reduction
Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution
Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)
Works with Development Engineers to effectively transfer new products to Manufacturing
Complete design and development projects by training and guiding technicians and assemblers
Create verification /validation protocols (IQ,OQ,PQ), lead the execution activities, generate relevant data and provide corresponding documentation and reports
Comply with company’s policies and guidelines regarding design control, validation activities and documentation

Qualifications

Bachelor’s Degree in Mechanical, Chemical, Manufacturing or related engineering fields
3-7 years hands-on experience in a manufacturing environment with proven track record of process development /optimization and validation
Excellent verbal, written, presentation and interpersonal skills
Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.
Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
Extensive experience with process capability studies, FMEA, PPK, 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
Diverse background in process characterization and optimization in a manufacturing environment.
Hands-on proactive approach to problem solving
Requires interaction and collaboration with a cross-functional team

Preferred Qualifications

Experience with Statistical Software tools such as Minitab or JMP
Knowledge and/or hands-on experience with metrology tools such as CMM, Micro-Vu, SEM, etc.
Familiarity with cleaning and sterilization processes
Working knowledge of Solidworks

PROJECT MANAGER (PHARMACEUTICAL & MANUFACTURING)

Position Available

The Project Manager is responsible for managing new technology projects from design through development and validation and start up phases. Lead cross-functional teams (including R&D, Manufacturing, Engineering, Validation and Facilities) to execute development projects to successful startup. Projects include manufacturing and packaging technologies located at internal and third-party manufacturing.

Essential Duties and Responsibilities

Lead (coordinate, facilitate, and motivate) the efforts of the individual, team, and other resources associated with project activity.
Manage projects within the established scope and the schedule agreed to with internal stakeholders.
Develop project plans and schedules that represent the appropriate level of detail and task interdependency.
Develop and document high-level strategies for achieving specific objectives or activities (hierarchical strategy, process flow, final project summary, etc.)
Manage change and/or conflict within any project in an effective, timely, and appropriate manner.
Professionally communicate verbally with a broad spectrum of audiences, ranging from outside contractors to internal senior level executives.
Project responsibilities include defining scope, objectives, identifying resources, building timeline, and creating project documentation to meet established project goals.
Responsible for project risk management (scope, schedule, costs, quality). Takes necessary steps to communicate, mitigate and develop contingency plans for identified risks.
Closely monitors and tracks project activities to ensure project is adhering to agreed timelines. Monitors performance and makes recommendations.
Prepares project status reports and regularly communicates and presents project status updates to stakeholders and management.

Education and/or Experience

Bachelor’s Degree in science, Business, Industry or related fields.
Five plus years of experience in FDA regulated environment such as Pharmaceutical, OTC, Biotech, Nutraceuticals, and/or cosmetics or equivalent combination of education, training and/or experience.
Five plus years of project management experience leading cross functional teams.

CIVIL ENGINEER-NEW BRITAIN, CT

Position Available

Looking for a (PE) Professional Engineer for one our clients. Our client has two primary lines of business - petroleum and environmental services. However, our client is growing its Civil Engineering consulting services practice and hiring a Project Engineer who has a Professional Engineers (PE) License in Civil Engineering.

The Project Engineer is required to have a PE because only a licensed engineer may prepare, sign and seal, and submit engineering plans and drawings to a public authority for approval, or seal engineering work for public and private clients.

The new hire will manage two civil engineers in our clients’ Connecticut office. The new hire will take over the day-to-day operations such as technical proposal writing, executing client contracts, invoicing for technical services, managing relationship with the existing customer base, etc.

The new hire will require excellent organizational skills and manage multiple client projects in RI, CT, MA, NH.

Our client provides consulting services to clients who are building a new gas station or renovating existing gas stations. The new hire will oversee codes, permits, design works, specification of components such as gas tanks, pipes, buildings and structures, canopy, tank swap out, etc.

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