Project Engineer
Location
Utrecht, The Netherlands
Department
Manufacturing
Job Description
Posted on:
September 27, 2023
We are seeking a highly skilled and motivated Project Engineer to join our dynamic and innovative medical device manufacturing organization. As a Project Engineer, you will play a critical role in managing and executing projects related to the development, design, and manufacturing of medical devices. This is an exciting opportunity to contribute to the improvement of healthcare and make a meaningful impact on the quality of life of people with diabetes type 1.
Responsibilities
Main Responsibilities include but are not limited to:
- Lead/execute complex manufacturing engineering projects including those at 3rd party manufacturing sites by means of Project Management tools and techniques.
- Identifying the scope of work, analyzing, communication and addressing out of scope situations
- Keeping track of project schedule and cost and develop strategies to avoid deviations
- Managing human/financial resources to deal with resource shortages
- Capturing risks/opportunities to develop a response strategy
- Ensuring the information is effectively communicated to affected parties
- Analyzing and meeting the needs and expectations of the stakeholders
- Design, development, introduction and optimization of manufacturing equipment, processes, and methods, utilizing knowledge of product design, materials, manufacturing processes, tooling, equipment, and quality control standards.
- Design, develop and qualify new tooling and equipment.
- Evaluate existing manufacturing processes and ensure continuous improvement and production yield increases.
- Evaluate and implement process improvements to existing processes via quality improvement, component cost reduction and improving test methods
- Create/revise manufacturing plans, work instructions, process specifications and procedures.
- Lead/support verification/validation of processes, machines and equipment to meet requirements of Medical Device Regulations and Company procedures including IQ/OQ/PQ protocols.
- Produce process qualification and validation documentation.
- Execute activities, as part of a cross functional team, in alignment with other functions and in compliance to standards in place for the medical industry.
- Communicate effectively with management, peers, and vendors.
- Keeping current with relevant scientific and technical developments.
- Accomplish goals by accepting ownership and explore opportunities to add value to job accomplishments.
- Ensure all work is undertaken and completed with a high level of accuracy and attention to detail within a defined and agreed timeframe.
- Work independently with minimal supervision as well as ability to work closely with the teams from different departments.
- Ensure compliance with all regulatory, legal and Company policies and procedures
Job Requirements
Education/Experience:
- Bachelor of Science in Manufacturing, Industrial or Biomedical Engineering
- Proven Project Management skills through the delivery of business-critical manufacturing projects.
- Preferably PMP certified
- Strong English language communications skills (verbal, written and presentation)
- Highly skilled in use of MS Office tools
- Proficient in use of project management tools such as MS Project
- Demonstrated experience presenting data in meaningful and relevant fashion to aid in decision making process
- Preferably holding Six Sigma certification (green belt or above)
- Having knowledge and experience in process validation stages FAT/SAT, IQ/OQ/PQ, PC/TMV
- Attention to details
- Experienced in working as part of a multi-disciplined team in a dynamic and results motivated environment
- Previous experience working with ISO 13485 or 21 CFR 820
Embedded software engineer
Job Description
Posted on:
September 27, 2023
We are seeking a highly skilled and motivated Project Engineer to join our dynamic and innovative medical device manufacturing organization. As a Project Engineer, you will play a critical role in managing and executing projects related to the development, design, and manufacturing of medical devices. This is an exciting opportunity to contribute to the improvement of healthcare and make a meaningful impact on the quality of life of people with diabetes type 1.
Main Responsibilities include but are not limited to:
- Lead/execute complex manufacturing engineering projects including those at 3rd party manufacturing sites by means of Project Management tools and techniques.
- Identifying the scope of work, analyzing, communication and addressing out of scope situations
- Keeping track of project schedule and cost and develop strategies to avoid deviations
- Managing human/financial resources to deal with resource shortages
- Capturing risks/opportunities to develop a response strategy
- Ensuring the information is effectively communicated to affected parties
- Analyzing and meeting the needs and expectations of the stakeholders
- Design, development, introduction and optimization of manufacturing equipment, processes, and methods, utilizing knowledge of product design, materials, manufacturing processes, tooling, equipment, and quality control standards.
- Design, develop and qualify new tooling and equipment.
- Evaluate existing manufacturing processes and ensure continuous improvement and production yield increases.
- Evaluate and implement process improvements to existing processes via quality improvement, component cost reduction and improving test methods
- Create/revise manufacturing plans, work instructions, process specifications and procedures.
- Lead/support verification/validation of processes, machines and equipment to meet requirements of Medical Device Regulations and Company procedures including IQ/OQ/PQ protocols.
- Produce process qualification and validation documentation.
- Execute activities, as part of a cross functional team, in alignment with other functions and in compliance to standards in place for the medical industry.
- Communicate effectively with management, peers, and vendors.
- Keeping current with relevant scientific and technical developments.
- Accomplish goals by accepting ownership and explore opportunities to add value to job accomplishments.
- Ensure all work is undertaken and completed with a high level of accuracy and attention to detail within a defined and agreed timeframe.
- Work independently with minimal supervision as well as ability to work closely with the teams from different departments.
- Ensure compliance with all regulatory, legal and Company policies and procedures
Job Requirements
Education/Experience:
- Bachelor of Science in Manufacturing, Industrial or Biomedical Engineering
- Proven Project Management skills through the delivery of business-critical manufacturing projects.
- Preferably PMP certified
- Strong English language communications skills (verbal, written and presentation)
- Highly skilled in use of MS Office tools
- Proficient in use of project management tools such as MS Project
- Demonstrated experience presenting data in meaningful and relevant fashion to aid in decision making process
- Preferably holding Six Sigma certification (green belt or above)
- Having knowledge and experience in process validation stages FAT/SAT, IQ/OQ/PQ, PC/TMV
- Attention to details
- Experienced in working as part of a multi-disciplined team in a dynamic and results motivated environment
- Previous experience working with ISO 13485 or 21 CFR 820
Responsibilities
The position
The ViCentra Software Engineering team is expanding and looking for embedded software engineers across a range ofexperience to work on medical device software for our innovative insulin pump therapy and connectedsolutions. These solutions combine advanced embedded software development, algorithms, usability, & 3rd partytechnologies into sleek and easy to use devices for our users. You will work as part of a multi-disciplinary product designand development team to bring innovative products to the markets at scale.
About ViCentra
ViCentra is an innovative medical device company which focuses on the research and development, manufacturing and commercialisation of a ground-breaking device for the management of diabetes.Kaleido, the smallest and lightest insulin pump system currently available, is designed to help people with diabetes live life on their own terms:"For us, super accurate insulin delivery and improved control are non-negotiables, but discretion, simplicity and choice is our way of helping you live life in your own way"Driven by ViCentra's desire to be meaningfully different, Kaleido aims to reduce the impact that diabetes can have on daily life. Utilizing Bluetooth wireless technology, Kaleido infuses colour and choice into the market, networking its hybrid patch pumps and handsets into a broader family of easy-to-use products and data services to create a customerfocused, integrated diabetes support service.With CE mark, ViCentra is setting its sights on expanding insulin pump usage by appealing to both first time and experienced insulin pump users in the Netherlands and the UK. At the same time, we are preparing for additional territories in 2021.Funded by the venture capitalists LSP, INKEF, Health Innovations and NL-Invest, ViCentra currently employs over 70people.
Kaleido
• The smallest and lightest insulin pump system currently available
• Unique pump drive mechanism to ensure accurate delivery
• Proprietary and IP protected
• Low manufacturing cost of disposable insulin Cartridge
• Platform for connectivity
• Unique pump drive mechanism to ensure accurate delivery
• Proprietary and IP protected
• Low manufacturing cost of disposable insulin Cartridge
• Platform for connectivity
Responsibilities:
• Contribute to multiple projects within the software design team throughout the full productdevelopment life cycle, ensuring projects are delivered on time and budget and comply with all approvedQuality & Regulatory Processes and guidelines as well as legal and company policies and procedures .
o Prototyping, testing, and reporting of early stage technology feasibility activities.
o Development of software requirements, specifications, and testing plans/protocols where required.
o Implement coding solutions aligned to the intended design specification and utilising bestin class technologies and standards.
o Participate in peer code reviews.
o Perform necessary verification/validation, release and Design Transfer activities according to approved procedures.
• Keeping current with relevant scientific and technical developments and contributing to a best in class software development environment
o Prototyping, testing, and reporting of early stage technology feasibility activities.
o Development of software requirements, specifications, and testing plans/protocols where required.
o Implement coding solutions aligned to the intended design specification and utilising bestin class technologies and standards.
o Participate in peer code reviews.
o Perform necessary verification/validation, release and Design Transfer activities according to approved procedures.
• Keeping current with relevant scientific and technical developments and contributing to a best in class software development environment
The ideal candidate to join our team should have:
• 3+ years experience of embedded programming in C / C++/ C#/ python.
• Previous involvement in all development stages including software architecture /design, testing andrelease.
• Experience of testing embedded software applications, e.g. unit, integration and system testing.
Experience of automation of tests for embedded applications is a distinct advantage.
• Experience with compliance and standards, e.g., IEC60601-1, IEC 62304, IEC 62366, ISO 14971, ISO 13485& 21 CFR 820 is a distinct advantage.
• Experience in developing and integrating medical device software to communicate to mobile platforms(Android, iOS), wearables, and related tools.
• Track record in delivering in a timely fashion.
• Ability to work independently with minimal supervision, structuring your own deliverables, whileensuring delivery of outcomes
• Ability to work in a cross-functional R&D team of electrical/electronic, software, systems and mechanicalengineers as well as teams from different departments/disciplines.
• Ability to complete work with a high level of accuracy and excellent attention to detail.
• A high level of self-motivation and drive to accomplish goals by accepting ownership and exploringopportunities to add value to job accomplishments.
• Ability to communicate clearly and efficiently with management, peers and 3rd party providers. Excellentwritten and oral communication skills in English. Dutch language is not required.It’s a bonusif you also have:
• Experience in a Start-Up/ early-stage commercial company.
• Previous involvement in all development stages including software architecture /design, testing andrelease.
• Experience of testing embedded software applications, e.g. unit, integration and system testing.
Experience of automation of tests for embedded applications is a distinct advantage.
• Experience with compliance and standards, e.g., IEC60601-1, IEC 62304, IEC 62366, ISO 14971, ISO 13485& 21 CFR 820 is a distinct advantage.
• Experience in developing and integrating medical device software to communicate to mobile platforms(Android, iOS), wearables, and related tools.
• Track record in delivering in a timely fashion.
• Ability to work independently with minimal supervision, structuring your own deliverables, whileensuring delivery of outcomes
• Ability to work in a cross-functional R&D team of electrical/electronic, software, systems and mechanicalengineers as well as teams from different departments/disciplines.
• Ability to complete work with a high level of accuracy and excellent attention to detail.
• A high level of self-motivation and drive to accomplish goals by accepting ownership and exploringopportunities to add value to job accomplishments.
• Ability to communicate clearly and efficiently with management, peers and 3rd party providers. Excellentwritten and oral communication skills in English. Dutch language is not required.It’s a bonusif you also have:
• Experience in a Start-Up/ early-stage commercial company.
What we offer
In addition to working on a ground breaking new product, you’ll be working in a small, friendly and highly motivatedteam with excellent career prospects; all ideas are welcomed and great work is rewarded. We’re also offering:
• A very competitive salary
• Permanent contract
• Competitive relocation package and assistance
• Assistance for 30% ruling application if applicable
• Sponsorship if applicable
• 32 days’ holiday per year (pro rata) + 5 optional purchase days
• Full time (40 hours per week) 8 hours per day to be worked anytime between 07:00 to 19:00 Monday toFriday
• Contribution towards commuting costs
• A work environment where you can develop your skills, learn from the best and be rewarded for yourimagination
• Free, on-site parking
• Social events and team lunches
• Creative office vibe with a picnic area, beanbags and ping pong table
• Informal dress code
• Meaningful work with the opportunity to make a difference
• A very competitive salary
• Permanent contract
• Competitive relocation package and assistance
• Assistance for 30% ruling application if applicable
• Sponsorship if applicable
• 32 days’ holiday per year (pro rata) + 5 optional purchase days
• Full time (40 hours per week) 8 hours per day to be worked anytime between 07:00 to 19:00 Monday toFriday
• Contribution towards commuting costs
• A work environment where you can develop your skills, learn from the best and be rewarded for yourimagination
• Free, on-site parking
• Social events and team lunches
• Creative office vibe with a picnic area, beanbags and ping pong table
• Informal dress code
• Meaningful work with the opportunity to make a difference
Even More!
Working in Utrecht you will be working in one of The Netherlands oldest cities with a beautiful medieval centre arranged around canals. Providing a vibrant, creative and international environment (with the largest University in The Netherlands) it is the fourth largest city in the country. It is situated in the centre of the country 48km south of Amsterdam (27 minutes by train) and as such is within easy travel of a number of cities and sights. Moreover, we have a work hard/ play hard approach and believe in creating a fun, exciting work environment. The free coffee and snacks help too!
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