Have you been reviewing job postings online but feel like you don’t fully understand all the requirements of the role? This is common as a recent graduate, as job descriptions make use of a lot of industry terminology you won’t be familiar with yet, let alone have direct experience in. The difficulty here is that when interviewing for these roles you may be asked about your knowledge on certain points from the job description, and the last thing you want to happen is to be left with nothing to say to a question except “I don’t know”.
That is why we are working on this series of blogs, where we will be analyzing job postings from some of the largest Medtech companies in the world and breaking down the information in a way that you can use to study and prepare for the interview. This first role we are looking at is advertised as a Manufacturing Engineer I. Below we have broken out the entire job spec line by line and provided more information as to what is exactly meant – we hope that this is something you can benefit from!
The Job Spec
Provide engineering support to manufacturing operations with an emphasis on New product process development. Supports design and development of all facets of manufacturing production line such as layout, equipment specification/design/procurement, work instruction generation, capacity analysis, process capability setup specification, etc.
The key areas of this paragraph are underlined above and expanded on below.
1. This is a manufacturing role with an emphasis on new product process development – so not your typical manufacturing role where you are managing a line. Instead, you will be working with process development engineers to transfer the product into a fully commercial (sold on the market) state.
2. Some of the areas of work are also outlined here:
a. Line layout – The positioning and “flow” of the production line. If you can imagine a very simple line where there are 3 machines for 3 different process steps which are required to be completed sequentially. The correct line layout for these machines would be side by side to reduce wasted time for the operators using the machines moving between each one. In reality, this is far more complex. Some machines may only be able to be positioned in certain areas due to requirements for facilities (air extraction, electricity, pressurized air, etc.) needed to operate the machine. Your role would be in considering the constraints around laying out the line and then ensuring that it is still laid out in a logical way to maximize production output and safety.
b. Equipment specification/design/procurement – These points are all related but may not be required for every piece of equipment. To elaborate, imagine a step where a part must be cut to 10mm +/-1mm. This will form part of your specification. You could then take it upon yourself to design a cutting fixture to achieve this goal and then follow through with procurement with a tooling vendor. Now imagine a similar process step but the part is now required to be cut to 10mm +/-0.1mm. You may now think that your simple cutting fixture will not be accurate enough, this time you would look for a specialized vendor to help you achieve the cut. So, the design is now completed out of the house, or more likely, an off-the-shelf piece of equipment is purchased which can achieve your tolerances.
c. Work instruction generation – Work instructions tell the operators how a part is made. They will detail everything from turning on the machine to how to clean up once the manufacturing step is completed. In developing these you will use a lot of images to make it as clear as possible for the person following the instruction to interpret and understand. You will also list critical inputs to the process such as equipment numbers (everything used to make commercial products is numbered for traceability purposes e.g. gauges, machines, rulers, etc.) and settings for the different machines if they are required to be manually inputted.
d. Capacity analysis – An example works best here. You require to make 100 parts a day. You must analyze your production line/ step to ensure that you can meet this demand. This would mean completing a timing study so you know exactly how long each part of your process takes, as well as telling you what parts of your process are bottlenecks (these would need to be fixed either by better tooling/ more machines/ bigger machines/ more people, etc.).
e. Process capability – This is a term used across all engineering disciplines, not just medical devices. It relates to the use of statistical analysis to gain insights into your process. The below video provides a good introduction to this.
Day in the life: • Design, fabrication, procurement, installation, and qualification of manufacturing equipment.
The first 3 points have been covered above. Installation and qualification refer to procedures that must be followed to ensure the equipment can be used for its intended purpose. A qualification would most likely be using some form of engineering study to prove that it produces good quality parts etc.
• Support characterization of the manufacturing process steps to understand the Input-Process and Output (IPO relationship on the process).
Input Process and Output can be used in characterizing all manufacturing steps. It helps engineers identify variables before planning trials. For example, a curing process may look like the below.
From reviewing the inputs you may decide that the inputs you want to investigate are temperature and time, but you will also be monitoring the other variables and keeping them fixed where possible so that your trial results will not have unknown variables.
• Identify pFMEA risks and implement associated mitigations.
The pFMEA document describes what can go wrong within a process and the risk that this can have downstream. Taking the above curing process as an example, you could identify what could go wrong if the curing time is too short in your process step. Let’s say the tensile strength of the part is too low when this happens – this is now your failure mode. You would then examine the risk of having a part that does not meet the required tensile strength, this would likely be a high risk. The final part of the pFMEA document would explain your mitigation for this occurring, so for example the curing program is automated or a sample from each batch is tested, etc. This then lowers your risk for this process step.
• Develop process documentation and train appropriate personnel on the contained information.
Process documentation is extremely broad and could mean several things, but as training is mentioned they likely mean training operators to work instructions, which we discussed earlier.
• Approve and manage design changes and process changes for adherence to company requirements.
Change control is a critical feature of a Quality Management System (QMS). The management and control of the process and design changes are controlled through change notices (they have different acronyms/names depending on the company). The purpose of these change notices is for traceability. It will allow auditors/engineers to determine what was completed at certain time points and for certain manufacturing lots. Changes seldom happen in isolation, if a design change is made for a feature of a part, then it is likely that the manufacturing instruction must also be changed so that the production steps reflect the new design. The change notice system will mean that the change cannot come into effect until the right people are notified and have reviewed the change, for example, the design engineer and the process engineer, and a member of quality engineering as an independent reviewer. Once the change is fully signed off it is implemented, any old revisions of drawings/manufacturing, and instructions are removed from circulation, and people are retrained/notified about the new change.
• Candidate must have the ability to communicate effectively with team members and functional management.
Functional management would likely refer to a manager of the manufacturing department and a process development manager in this case, as these are the two people overseeing the work of their teams on this project.
• Ensure adherence to product specifications, industry standards, and quality and regulatory procedures and requirements. Ensure personal understanding of all quality policies. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
You won’t be asked about this in an interview. All it is specifying is that you will ensure you read and understand all the documents provided to you about working within a regulated industry for your role. Training is critical for all employees and the responsibility falls on each individual to ensure their compliance.
• Construction of production routers and associated parameters to support production launch.
Your production router provides the “map” for your product as it is built. The titles/document numbers of the work instructions mentioned earlier in this post will form the inputs for your router and will allow operators to know the sequence to follow during the manufacture of the device. This is usually paired with your Bill of Materials (BOM) which describes all of the required materials needed at each step on your router.
Must-Have: Minimum Qualifications - Bachelor’s degree - 0+ years of experience with a bachelor's Degree
Nice to Have • Experience with CAD Modeling, Data Analysis, Technical Writing, Tolerance Analysis
CAD Modelling – Solidworks etc.
Data Analysis – Minitab. It would be good to learn some of the capabilities of the software prior before starting the job. Watch videos on how to perform a capability analysis, this will be the main use of the software for you and it will show enthusiasm for the role if you are already some way familiar with its use.
Technical Writing – You most likely have learned this through college and the completion of a capstone project.
Tolerance Analysis – There are several techniques to complete this, some using complex software, others a humble Excel spreadsheet. This is a simple 1D analysis using the worst-case scenario method.
• Understanding of manufacturing processes such as Assembly, Welding, Crimping, Curing, Soldering Cleaning, Anodizing, Coatings, and Polishing
We will be providing a blog in the coming weeks focusing on an overview of common manufacturing techniques used in the Medtech Industry as it is too broad to go into detail in this post. • Effective interaction with personnel at diverse positions within the organization. • Value others' ideas and experience working in a team environment.
These are self-explanatory points, although one thing worth bearing in mind is the reference to a team environment. We mention in other blogs the importance of showing a team focus on your resume and you will see it referenced regularly on job specifications such as this one so ensure you have it included and can speak towards how you effectively work on a team in an interview situation also.
• Analytical and problem-solving mindset with a drive towards applying these skills to resolve technical problems in a manufacturing environment by employing tools such as DMAIC thinking and Root Cause Analysis.
• Able to follow technical lead while also providing individual input.
As a junior engineer, you will be paired with someone with several years’ experience in the role. They will provide you with your tasks and give technical feedback on your work. Being able to follow a technical lead means that you will be following instructions diligently and keeping good records of any work you have completed to make reporting results easy and clear with your senior. The individual input aspect refers to your initiative to complete work or come up with improvements. Any potential ideas you have should be run past someone more experienced as getting their blessing is key.
And that concludes our rundown of a manufacturing engineer I job specification. After reviewing a few different job specifications, you will start to see trends in what the requirements are for these roles and how they differ minimally from company to company.
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