Company: DOTS Technology Corp
Posted on: August 7, 2022
About the Role We are looking to hire a Manufacturing Engineer
who is excited about joining a fast-paced team creating a life
changing product for consumers. You will utilize your experience in
a dynamic startup environment as a member of our Operations team.
You will work in deep collaboration with the Operations,
Engineering, Quality, Project Management, and Science functions to
efficiently manufacture our products within DOTS' manufacturing
operation and with our contract manufacturing supply base. -Who You
Are -You are a highly collaborative engineer that has successfully
launched products. Using your experience, you work seamlessly
between DOTS, equipment suppliers, and external manufacturing teams
to introduce new manufacturing lines, scale up production, increase
capacity, improve efficiencies, and reduce total costs. You are
intellectually curious and seek out and implement creative
solutions to fix problems. You also have led automation projects
and are familiar with smart factory concepts, ie IoT integration in
operations, data collection and analytics, and robotics and machine
learning. -Primary Responsibilities/Accountabilities:
- Develops, maintains and improves manufacturing procedures,
documentation, tools, fixtures, equipment, and manufacturing lines
on all DOTS' products
- In collaboration with Engineering, Quality, and Science,
responsible for planning, designing, developing, and maintaining
Work Instructions and Test Procedures for internal or contract
- Collaborates with internal and contract manufacturing to ensure
all staff receive training to effectively build the product and
verify the product's performance to specification.
- Work closely with internal and contract manufacturers and
sub-tier suppliers to design and qualify high capability processes
using process risk assessments (pFMEA), process flows, control
plans, process validations (IQ, OQ, PQ), and product acceptance
- Responsible for leading manufacturing product improvement
programs, including Productivity, Manufacturability, VA/VE,
Quality, and Reliability projects.
- Lead VA/VE as a systematic process to creatively assess and
generate alternatives to essential functions that provide the
- Lead and implement data-driven improvements within the
manufacturing operation for product design, assembly processes, and
supply chain management.
- Identify the root cause of manufacturing process and product
nonconformities. Identify and implement necessary actions to
correct and prevent recurrence though the corrective and
preventative action process.
- Initiate and/or approve all necessary changes in product
design, tooling, methods, processes and any documentation that
affects the manufacturability of an item or process, including
Process Validation protocols.
- Local and International travel is required. Ability to travel
up to 50% of the time.
- Performs duties in compliance with environmental, health and
safety related site rules, policies or governmental regulations.
-Minimum Educational Level:
- Bachelor's Degree in Electrical Engineering, Mechanical
Engineering or similar engineering discipline or related technical
- Masters degree is preferred. -Required Skills and Experience:
- years of relevant experience with Bachelors Degree OR 2+ years
of relevant experience with Masters Degree
- Understanding of Lean Manufacturing and Six Sigma,
certification preferred (Green Belt, Black Belt).
- Experience in high-volume manufacturing, preferably with
diagnostic and/or medical device products in an ISO certified
Quality Management System.
- A self-motivated team player with excellent verbal and written
communications skills. Must be able to convey business and
technical concepts to diverse stakeholders and technical teams in a
clear and concise manner.
- Ability to work independently and communicate with a vast
network of global stakeholders.
- Strong understanding of Master Validation, including Validation
Master Planning, Installation Qualification, Operational
Qualification, and Performance Qualification.
- Must enjoy a fast paced, dynamic environment and an inherent
nature to solve complex problems.
- Proficient with managing and understanding cross-cultural
- Experience performing in a fast-paced and time-sensitive
- Ability to work independently with minimal supervision on a
daily basis. -Nice to Have Skills and Experience:
- Demonstrated working knowledge of ISO 13485.
- Experience in Statistical methodologies; DOE, SPC, etc.
- Experience with CAD systems: SolidWorks (or equivalent),
Electrical Simulation Tools.
- Experience with process development, verification, and
validation and component / material qualification and acceptance
- Experience with risk management, including Process Failure Mode
Effects Analysis (pFMEA), Design Failure Mode Effects Analysis
(dFMEA), fault tree analysis, or other risk management tools.
- Experience in Windows applications including Microsoft
Keywords: DOTS Technology Corp, Boston , Manufacturing Engineer, Engineering , Natick, Massachusetts
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