Ra QA Lead

Looking for a

Ra QA
Lead

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Chicago area

About SMADE

SMADE a pioneer in the field of smart healthcare devices, is on track to bring innovation to the next level. To reach higher, SMADE is looking for a talented Ra Qa Lead 🥇 to take control of his/her future and help propel the company and set new industry standards.

SMADE is the place for those who want to collaborate 👥 and those who want to innovate 📱, for those who want to evolve and those who want to solve, for those who care and those who dare, for those who combine passion and ambition to take up great challenges. If you plan to play an active role in changing the dynamics of healthcare industry. You are in the right place.

 

Creativity, playfulness, optimism, excellence, openness, that’s words which define us!

Be ready to change the medical experience together? Let’s start!🚩

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You must be the one we are expecting!

We are looking for a dynamic and an experienced Quality & Regulatory Lead to join SMADE.
You will be part of an amazing team, taking on a position that will offer you a great opportunity to play a major part in the success of a growing business expanding its operations to international markets.

 

If you’re able to work within a team environment to create complex, innovative, high reliability systems promoting a more secure and responsible use of medical devices worldwide, this role is for you!

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Come as you are! In SMADE team, we are … IKEA assembly geniuses, triathletes, Mamma Mia lovers, Apple addicts, golf players and much more.

 

So if you too, you are a cooker 👨‍🍳 , a globetrotter 🌏, a dancer 💃🏽 , a hard-rock fan 🎶 or a hockey player 🏒and lot of other things and you think you have all chance to fulfill this position, don’t hesitate and hit “Apply”.

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Your mission, should you choose to accept it...

  • Provide quality management and regulatory affairs leadership across the business within a highly regulated medical devices environment.
  • Define regulatory strategy to accompany and facilitate product adoption by customer.
  • Responsible for the daily management of the Quality Management System to the ISO 13485 standard and all regulatory submissions to the relevant authorities.

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  • Raise our compliance level to reach the new MDR regulations & standards applicable to our business and product range, planning and delivering the Regulatory registration / submission documentation required to achieve global market access.
  • Ensure the planning and hosting of external Quality audits/ inspections while continuously improving our processes.

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👩🏽‍💻For our teammates, the ideal colleague is …

  • A Bachelor’s degree in a relevant subject or suitable experience in a Regulatory/Quality role.
  • 3+ years of experience as a RAQA manager or similar role. Experience from the healthcare industry and IoT is a plus.
  • Excellent knowledge of MDD/MDR regulations as well as ISO 13485, CE and FDA requirements, with experience supporting regulatory submissions.
  • Proven track record of regulatory submissions of technical files.
  • Proven track record of preparing for and managing successful Quality audits / inspections

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You are...

  • You are devoted, enthusiastic, autonomous, curious and fun! 🥳
  • Ability to think strategically and execute methodically.
  • Excellent written and oral communication skills.
  • You are results-oriented, upbeat and focused with a strong passion to learn and succeed 🎯
  • Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
  • Ability to multitask and prioritize while managing multiple projects and day to day responsibilities.
  • Ability to influence cross-functional teams without formal authority.
  • Strong attention to detail and an ability to deal with ambiguity

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Our promise...

🔝An opportunity to take part in an innovative project at the service of the medical devices, and the improvement of life.

😁A strong team spirit, a caring work atmosphere and a ton of humor, come with your best jokes.

👨‍👦Work/life balance.

💡Express yourself, at SMADE we encourage all new ideas.

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Our recruitment journey...

It’s a cruise 🚢 one along which you will undoubtedly meet Marion 👩🏻‍💼our HR pilot who is there to steer you in the right direction. She will introduce you to your future skipper 👩🏽‍✈️who will give you an overview of the route the company has taken as well as the future destinations it intends on reaching. And finally, a last meeting with our Captain 👨🏻‍✈️

 

So if you are an adventurer 🪂 like us and you are looking to explore new horizons, then jump aboard!

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Apply for this Job


Embedded Software Engineer

Looking for an

Embedded
Software Engineer

-

Chicago area

About SMADE

SMADE a pioneer in the field of smart healthcare devices, is on track to bring innovation to the next level. To reach higher, SMADE is looking for a talented Embedded Software Engineer 🥇 to take control of his/her future and help propel the company and set new industry standards.

SMADE is the place for those who want to collaborate 👥 and those who want to innovate 📱, for those who want to evolve and those who want to solve, for those who care and those who dare, for those who combine passion and ambition to take up great challenges. If you plan to play an active role in changing the dynamics of healthcare industry. You are in the right place.

 

Creativity, playfulness, optimism, excellence, openness, that’s words which define us!

Be ready to change the medical experience together? Let’s start!🚩

-

You must be the one we are expecting!

We need a dynamic, successful Embedded Software Engineer to join SMADE. You will be part of an amazing team 🤩 to create electronics systems that meet and exceed internal and external customer’s new product specifications. You will be responsible for designing, developing, modifying, evaluating … software function or integrated new function or component for a given implementation. You will also focus on existing products by troubleshooting issues (need to get rid of those), evaluating alternative solutions and maintaining relevant documentation (not the most exciting but very important). If you’re able to work as part of a team to realize complex, innovative, high reliability systems that will allow a more secure and responsible use of medical devices worldwide, this role is for you!

-

Come as you are! In SMADE team, we are … IKEA assembly geniuses, triathletes, Mamma Mia lovers, Apple addicts, golf players and much more.

So if you too, you are a cooker 👨‍🍳 , a globetrotter 🌏, a dancer 💃🏽 , a hard-rock fan 🎶 or a hockey player 🏒and lot of other things and you think you have all chance to fulfill this position, don’t hesitate and hit “Apply”.

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Your mission, should you choose to accept it...

Primary responsibility is to ensure the overall product functionality and meet all applicable technical specifications:

  • Writing firmware for mixed-signal embedded systems and communications interfaces
  • Design of generic software architecture combining many variants of products: each variant should be selected by calibration parameters: by considering sensor and actuator input/output
  • Develop test suite packages helping the commercial team demo during meeting with customer
  • Sustaining engineering support for existing embedded design
  • Monitor external supplier developing an application to collect information from our products
  • Develop data analyze tools or functions to evaluate the real time usage of all the production delivered to customer
  • Analyze equipment to establish operating data, experimental tests and evaluate results
  • Provide component selection based on evaluation data and analysis of specification
  • Apply developed subject matter knowledge to solve common and complex business issues within established guidelines and recommend appropriate alternatives
  • Development schedule, meet various deliverables, resolve technical issues, and ensure product meets specification and quality goal
Embedded SW/firmware validation:

  • Prepare test plan and test procedure for validation of subsystems of the design: Define the test matrix, Define the acceptance criteria, Prepare test plans and test procedures for the validation of the system

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Embedded Software/firmware design:

  • Analyze customer (internal and external) needs and determine component compatibility between Hardware and Software
  • Existing product improvement or new design initialization for new product generation
  • Definition of SW architecture by considering all the useful inputs
  • Analysis of mixed signal and apply the adequate digital filtering process: analog and digital component
  • Evaluate systems and recommend design modifications
  • Production of relevant design documentation, best practices and lesson learned
  • Creation of engineering specifications from product definitions and customer requirements, including flowcharts, block diagrams, charts
  • Definition of embedded system design and test milestones and estimates timelines
  • Write firmware to deliver required functions of the embedded device
Project core team member:

  • Work with project managers to ensure that projects are completed satisfactorily, on time, and within budget
  • Monitor the partners and suppliers
  • Coordinate with the design team in developing new design ideas and techniques
  • Review and recommend changes to existing designs to improve performance and quality
  • Participate in the system and lead the software DFMEAs

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👩🏽‍💻For our teammates, the ideal colleague is …

  • Minimum Qualification BS required 👨‍🎓Masters Degree preferred with Electrical/Electronic
  • Engineering or Computer Engineering Degree.
  • Minimum 5+ years experiences required:

Experience in these areas are a plus: Automotive, Medical, Telecommunication industries,

Significant Experience with C and C++ are mandatory,

Significant development experience in implementing in embedded real-time environments such as ARMs in C or C++,

Demonstrate experience using electronic controller architectures: preferred knowledge with Microchip (AVR&PIC), Renesas, NXP, STM32,

Demonstrate Practical knowledge and experience with I2C, SPI, UART,

Understanding electrical PCB Schematic is desired,

Perform advanced research, explore and prove out new technologies in the market for continuous improvement,

Experience with low power and battery powered embedded devices is high plus,

Experience working during proof of concept phase, prototyping and production.

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  • Software Design or functions should apply electrical engineering principles and techniques to accomplish goals
  • Proficiency in using basic Hardware design validation/measurement equipment such as Oscilloscope, Signal generator, Spectrum Analyzer, DC power supplies, etc.
  • Perform root cause analysis of design issues and develop effective resolutions
  • The plus: General Knowledge of ISO (medical norm) Standards and Requirements, Experience in these areas: Automotive, Medical, Telecommunication industries.

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You are...

  • You are devoted, enthusiastic, autonomous, curious and fun! 🥳
  • You have good analytical skills, think global and execute methodically.
  • You have excellent communication skills (ability to write, report, present and summarize), self-managing initiative, and detail oriented.
  • You are results-oriented, upbeat and focused with a strong passion to learn and succeed 🎯
  • You have good adaptability and good interpersonal skills to be able to work within a small structure, team-oriented attitude.
  • You have ability to influence cross-functional teams without formal authority.
  • You are able to multitask and prioritize while managing multiple projects and day to day responsibilities.
  • You have strong attention to detail and an ability to deal with ambiguity.

-

Our promise...

🔝An opportunity to take part in an innovative project at the service of the medical devices, and the improvement of life.

😁A strong team spirit, a caring work atmosphere and a ton of humor, come with your best jokes.

👨‍👦Work/life balance.

💡Express yourself, at SMADE we encourage all new ideas.

 

Range of salary: between $75,000 and $95,000 + Benefits (Medical, Vision, Dental, 401k matches, and other benefits).

-

Our recruitment journey...

It’s a cruise 🚢 one along which you will undoubtedly meet Marion 👩🏻‍💼our HR pilot who is there to steer you in the right direction. She will introduce you to your future skipper 👩🏽‍✈️who will give you an overview of the route the company has taken as well as the future destinations it intends on reaching. And finally, a last meeting with our Captain 👨🏻‍✈️

So if you are an adventurer 🪂 like us and you are looking to explore new horizons, then jump aboard!

-

Apply for this Job


Electrical/Electronics Hardware Engineer

Looking for an

Electrical/
Electronics Hardware Engineer

-

Chicago area

About SMADE

SMADE a pioneer in the field of smart healthcare devices, is on track to bring innovation to the next level. To reach higher, SMADE is looking for a talented Electrical/Electronics Hardware Engineer 🥇 to take control of his/her future and help propel the company and set new industry standards.

SMADE is the place for those who want to collaborate 👥 and those who want to innovate 📱, for those who want to evolve and those who want to solve, for those who care and those who dare, for those who combine passion and ambition to take up great challenges. If you plan to play an active role in changing the dynamics of healthcare industry. You are in the right place.

Creativity, playfulness, optimism, excellence, openness, that’s words which define us!

Be ready to change the medical experience together? Let’s start!🚩

-

You must be the one we are expecting!

We need a dynamic, successful Electrical/Electronics Engineer to join SMADE.
You will be part of an amazing team and will work to create and deliver electronics systems to meet customer groundbreaking new product specifications.
You will be responsible for designing, developing, modifying and evaluating electronic components or integrated circuit for a given implementation including (but not limited to!) PCB specification, schematics, design, qualification, system

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integration and validation tests, product manufacturing supervision. You will also support existing products by troubleshooting issues (need to get rid of those), evaluating alternative components, and maintaining relevant documentation (not the most exciting but very important).
If you’re able to work as part of a team to realize complex, innovative, high reliability systems that will allow a more secure and responsible use of medical devices worldwide, this role is for you!

Come as you are! In SMADE team, we are … IKEA assembly geniuses, triathletes, Mamma Mia lovers, Apple addicts, golf players and much more.

So if you too, you are a cooker 👨🍳 , a globetrotter 🌏, a dancer 💃🏽 , a hard-rock fan 🎶 or a hockey player 🏒and lot of other things and you think you have all chance to fulfill this position, don’t hesitate and hit “Apply”.

-

Your mission, should you choose to accept it...

  • Ensure the overall product functionality and meet all
    applicable technical specifications through electrical
    embedded product design and product validation.
  • Analyze customer (internal and external) needs and
    determine electrical system requirements, capacity, and
    cost to develop a system plan.
  • Create engineering specifications from product specs and
    customer requirements, including flowcharts, schematics,
    block diagrams, charts, and written descriptions as
    needed.

Create design simulations and PCB layout.

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  • Propose design validation plan to meet technical product,
    safety requirements and end-of-life test procedures.
  • Produce the relevant design documentation, best
    practices and lesson learned.
  • Prepare test plan and test procedures the validation of
    the system and participate in the system and lead the
    electronic component DFMEAs.
  • Focus on existing product improvement, review and
    recommend changes to existing designs to improve
    performance and quality

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Here’s what it takes

  • Minimum Qualification BSEE required.
  • Masters Degree preferred with Electrical/Electronics
    Engineering.
  • 3 to 5 years of experience required in some combination
    of the following areas: Automotive, Medical,
    Telecommunication electronics product development.
  • Must demonstrate expertise using Schematic design,
    simulation and Circuit layout tools such as Altium
    (preferred), PSpice, OrCAD, Mentor, Matlab/Simulink,
    Stateflow, etc.
  • Must have a good knowledge of using the electronic
    controller architecture, allocate hardware and software
    requirements (Preferred knowledge with Microchip
    (AVR), Renesas, NXP, TI processors). Experience with
    C and C++ are mandatory.
  • Designing, developing, and testing real-time systems
    (signal processing algorithms).
  • Significant development experience in implementing
    DSP modules in embedded real-time environments such
    as commercial DSPs, ARMs in C or C++.
  • Develop technical documentation including product
    specifications, layout instructions, test procedures, etc.
  • Perform advanced research, explore and prove out new
    technologies in the market for continuous improvement.
  • Interfacing with customers as well as other internal
    departments Essential Requirements.

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  • Strong understanding of electrical and electronics
    fundamentals including electromagnetics, passive and
    active components, and integrated circuits.
  • Demonstrable capabilities in more key areas of:
    Electronics design: Analog and digital Hardware,
    Microprocessor Architecture ; Physics: sensor, Control
    Circuits, RF antenna, etc ; Experience with schematic,
    PCB layout, circuit designs: Altium knowledge preferred.
  • Support compliance testing for EMI/EMC and
    certification at external certified labs.
  • Experience with low power and battery powered
    embedded devices is high plus.
  • Experience working during proof of concept phase,
    prototyping and production.
  • Support manufacturing plant for technical assistance
    during postproduction of the product.
  • Proficiency in using basic Hardware design validation
    equipment such as Oscilloscope, Signal generator,
    Spectrum Analyzer, DC power supplies, etc.
  • Perform root cause analysis of design issues and
    develop effective resolutions.
  • Perform the system risk analysis: DFMEA to valid the
    hardware design.
  • General Knowledge of ISO (medical norm) Standards
    and Requirements is a plus.

-

Now for the soft skills...

  • Ability to think strategically and execute methodically.
  • Excellent written and oral communication skills.
  • You are results-oriented, upbeat and focused with a strong passion to learn and succeed.
  • Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
  • Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
  • Ability to influence cross-functional teams without formal authority.
  • Strong attention to detail and an ability to deal with ambiguity

 

-

Our promise...

🔝An opportunity to take part in an innovative project at the service of the medical devices, and the improvement of life.

😁A strong team spirit, a caring work atmosphere and a ton of humor, come with your best jokes.

👨👦Work/life balance.

💡Express yourself, at SMADE we encourage all new ideas.

  • Range of salary: between $75,000 and $95,000 + Benefits (Medical, Vision, Dental, 401k matches, and other benefits).

 

-

Our recruitment journey...

It’s a cruise 🚢 one along which you will undoubtedly meet Marion 👩🏻💼our HR pilot who is there to steer you in the right direction. She will introduce you to your future skipper 👩🏽✈️who will give you an overview of the route the company has taken as well as the future destinations it intends on reaching. And finally, a last meeting with our Captain 👨🏻✈️

So if you are an adventurer 🧗🏽‍♀️ like us and you are looking to explore new horizons, then jump aboard!

 

-

Apply for this Job