Vacancies

“It’s not as if you’re saving lives.”

At Haermonics you will be. As a clinical stage medtech company developing innovative therapies to prevent post-operative cardiac surgery complications. What we do matters. What we do actually does save lives. Not a bad motivation to get going every morning.

In fact, every day 250 patients die from postoperative heart surgery complications caused by residual blood and clots in the pericardial cavity. Complications that we can help prevent. That’s why we’re looking to expand our teams with these positions:

Apply – or refer a friend – and save a life!

Under our Haermonics PURE-AT-HEART referral campaign, for every application we receive, we will donate €15 to the Dutch Heart Foundation (Hartstichting) for its life-saving research. So apply now or refer a friend. You have our heart-felt thanks.

Applications:

0

Donations:

100
Business Improvement Consultant / Operations Officer
In a cardiac surgery technology scale-up, your consulting skills elevate and deliver our organization processes

The ideal career kick-off as internal consultant who is responsible for design and implementation of the processes and procedures. Besides the design and implementation of business operations, you will also be responsible for the delivery. You play an essential enabling role for the entire Haermonics team. You’ll handle all business processes such as outsourcing, logistics, IT, administration and people and organisation activities. You report directly to the CEO and serve as his ‘right hand’. This is a long-term career opportunity to become Chief Operations Officer.


Your responsibilities:

  • The consultancy role is to design and implement optimal processes into procedures to enable the growth of our company
  • The operations role is to deliver the challenging result of those business processes
  • Responsible for all purchasing and logistics within the company
  • Design an onboarding program and align all staff to empower and ensure optimal individual and team performance
  • Ensuring all primary and secondary processes and operations are well organised and kept
  • Traceability of all supplies and stock
  • Contributing to the recertification of the ISO13485 standards (under responsibility of  the quality department)
  • Contributing to the customer value
  • Implementing and maintaining a Customer Relation Management system (Zoho, SalesForce or alike)
  • Understanding the dynamics and result-oriented phases of a scale-up and scale-up and ensuring the can-do mentality is part of your and the whole company’s culture

What you bring to the team:

To fulfill this role, you thrive on organising, professionalism and bringing people and processes together.

  • technical, logistics or business or M.Sc. in (e.g. Industrial Engineering, business administration or Industrial Design)
  • In your operations officer role, you deliver with a can-do mentality, so that the challenging company targets will be met.
  • 0-3 years of relevant industry experience; we look for bright new talent with management ambition
  • A quality-oriented mindset with a track record of driving improvements within our organisation
  • An excellent communicator, organised, wants to do good, perfection is the middle name, you understand that in your role, result is achieved by cooperation
  • project management skills and experience
  • Experience and ambition to work in a small, agile project team, preferably start-up/scale-up experience or mentality.
  • Strong collaboration and stakeholder management skills
  • Experience in Healthcare industry is a plus.
  • Proficiency in English, both written and verbal

What we offer:

Our goal is to save 10,000 lives by 2030. So we’re looking to build a dedicated team that we can count on, so that others can count on us. Besides a driven purpose, joining the Haermonics team will give you:

  • A competitive salary.
  • 28 Days of leave and the possibility to purchase up to 10 extra days off annually
  • Colleagues who are the best and brightest in their field
  • A personal development budget, free training and coaching (after all, remaining “the best and brightest” requires ongoing dedication)
  • A young, dynamic, international, high-tech scale-up environment, where you will collaborate daily with top-level medical device suppliers
  • Direct access to clinical practices and colleagues in leading academic centers
  • Option to join our Share Appreciation Rights plan (because our success is your success and we’re looking for long-term committers)


About Haermonics

When it comes to solving important, real-life medical problems, the Haermonics team brings discipline, creativity and extensive testing to each and every elegant solution. Currently conducting a clinical trial in 4 clinics of our innovative post cardiac surgery flushing technique, we’re in the final product development stages, aiming to go to market early 2024.

We are curious by nature. “Is there a better way?” is our daily reflection. Undaunted by the complicated, we understand that in every tangle of complexity, there lies an elegant solution. We strip a problem down to its essence. We simplify to clarify.  Because simplicity inspires action.  Above all, we believe in what we do. Unbound by convention, we are the change we want to see in the world. Viva la evolution.

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QA/RA Manager – Medical Devices
You’re the key to bringing our medical device to CE

As Quality Assurance & Regulatory Affairs Manager at Haermonics, you’ll play a critical role in the development and certification of medical device products. You understand the worlds of engineers, clinicians, and management; more importantly, you have the ability to inspire them to work with a quality mindset. You know what it takes to create a Technical File for submission to authorities and understand how this impacts our development process. We’re a startup, so you’re going to have a big impact and be directly involved in development, production and approval of our innovative products. In short, we’re looking for someone with the heart of a changemaker, the mind of a strategist and the hands of an engineer.


Your responsibilities:

In general, you’re the Keeper of all things Quality Assurance and System / Regulatory Affairs. More specifically you are expected to:

  • Play a vital role in developing new products
  • Are expert in the field of medical device regulations and product certification
  • Also play an important QA role in product development, working collaboratively with our strategic suppliers of system and disposables
  • Be responsible for the guarantee of safety of our products and ensuring working adherence to the Quality Management System
  • Coordinate regularly with our suppliers on QA/RA matters
  • Arrange the technical file for the certification of our products

What you bring to the team:

  • Minimum of 3 years of experience in Quality Assurance and Regulatory Affairs with regard to medical devices, with Class II/III devices, preferably in surgical applications, critical care, or patient monitoring
  • Knowledge of medical legislation and regulations, such as the new EU MDR, the FDA regulations, and applicable ISO/IEC standards
  • Affinity with working in a can-do startup setting (lean and compliant)
  • Experience in Quality Management
  • Setting up and management of an ISO 13485:2016 compliant QMS
  • Electronic document management
  • 21 CR 830, ISO 14971 / IEC 62304 / IEC 62366 / ISO 10079 / IEC 60601 / …..
  • Experience with QMS certification process via a Notified Body
  • Alignment with QMS’s of suppliers (system, disposables)
  • Quality Assurance – Records / Technical File
  • Supporting the team with creation of all required Technical File documents according the QMS and templates
  • Supporting Clinical Studies in collection of data and required evidence
  • Regulatory context:
  • Class III device (EU), DeNovo class II device with special controls (FDA)

What we offer:

Our goal is to save 10,000 lives by 2030. So we’re looking to build a dedicated team that we can count on, so that others can count on us. Besides a driven purpose, joining the Haermonics team will give you:

  • A competitive salary.
  • 28 Days of leave and the possibility to purchase up to 10 extra days off annually
  • Colleagues who are the best and brightest in their field
  • A personal development budget, free training and coaching (after all, remaining “the best and brightest” requires ongoing dedication)
  • A young, dynamic, international, high-tech startup environment, where you will collaborate daily with top-level medical device suppliers
  • Direct access to clinical practices and colleagues in leading academic centers
  • A share package (because our success is your success and we’re looking for long-term committers)

About Haermonics

When it comes to solving important, real-life medical problems, the Haermonics team brings discipline, creativity and extensive testing to each and every elegant solution. Currently conducting a clinical trial in 4 clinics of our innovative post cardiac surgery flushing technique, we’re in the final product development stages, aiming to go to market early 2024.

We are curious by nature. “Is there a better way?” is our daily reflection. Undaunted by the complicated, we understand that in every tangle of complexity, there lies an elegant solution. We strip a problem down to its essence. We simplify to clarify.  Because simplicity inspires action.  Above all, we believe in what we do. Unbound by convention, we are the change we want to see in the world. Viva la evolution.

Read more
Software Engineer - Medical Devices
The quality of your GUI will determine the patient’s quality of care  

In this role, you’ll be part of an enthusiastic multi-disciplinary team of dedicated engineers developing state-of-the-art systems and disposables for our flushing therapy, in combination with measurements and monitoring of patients in critical care. Your expertise will lead the software design, with a focus on the user interface part of the product. You’ll be expected to find the balance between functionality, quality, costs, and lead-time, while meeting international medical device product requirements/standards and medical device regulations (US-FDA and EU-MDR). Not only that, but you will need a wide variety of technical skills and reasoning in analyzing and designing superior software GUI’s that operate a class II/III medical device, running tests, improving/resolving product features, and sharing findings. We guarantee you’ll never be bored.


Your responsibilities:

  • Software design of existing and new products
  • Ability to determine/gather user requirements and translate them into design
  • Supporting proper Risk Management (e.g., FMEA on safety and technical/reliability aspects)
  • Develop GUI prototypes of Haermonics’ products with excellent usability
  • Collaborate with the software team of Haermonics’ lead supplier for the system/product
  • Co-create test-plans, co-execute actual tests and create/complete test-reports
  • Develop (embedded) software for flushing therapy and patient measurement and monitoring
  • Design software feature lists and support in planning the release schedule
  • Maintain a customer focused mindset, prioritizing product deliveries
  • Communicate, present, and defend opinions concerning the software architecture in a productive and collaborative fashion with strong focus on delivering results

 

What you bring to the team:

  • MSc or higher in computer science, embedded engineering, electronics, or relevant field
    • 3+ years proven working experience with (embedded) software technologies like C++11, QT5, QML, UML, Yocto, Bitbake, Unit tests
    • Preferably also experience with C++17 (current standard), QT6 (default in the market today), IEC 62304-based software development, UBoot
  • Expertise in embedded software and hardware architecture
  • Expertise with high-integrity software architecture & safety-critical systems
  • Strong written and oral communication skills
  • Strong interpersonal skills
  • Ability to present ideas in user-friendly language and visuals
  • High self-motivation and self-direction, with keen attention to detail
  • Ability to effectively prioritize and execute tasks in a high-pressure environment
  • Experience with agile methodologies
  • Experience with medical device software is preferred

 

What we offer:

Our goal is to save 10,000 lives by 2030. So we’re looking to build a dedicated team that we can count on, so that others can count on us. Besides a driven purpose, joining the Haermonics team will give you:

  • A competitive salary.
  • 28 Days of leave and the possibility to purchase up to 10 extra days off annually
  • Colleagues who are the best and brightest in their field
  • A personal development budget, free training and coaching (after all, remaining “the best and brightest” requires ongoing dedication)
  • A young, dynamic, international, high-tech startup environment, where you will collaborate daily with top-level medical device suppliers
  • Direct access to clinical practices and colleagues in leading academic centers
  • A share package (because our success is your success and we’re looking for long-term committers)

 

About Haermonics

When it comes to solving important, real-life medical problems, the Haermonics team brings discipline, creativity and extensive testing to each and every elegant solution. Currently conducting a clinical trial in 4 clinics of our innovative post cardiac surgery flushing technique, we’re in the final product development stages, aiming to go to market early 2024.

We are curious by nature. “Is there a better way?” is our daily reflection. Undaunted by the complicated, we understand that in every tangle of complexity, there lies an elegant solution. We strip a problem down to its essence. We simplify to clarify.  Because simplicity inspires action.  Above all, we believe in what we do. Unbound by convention, we are the change we want to see in the world. Viva la evolution.

Read more
Mechanical engineer / designer - Medical Disposables
You’re the artist that merges form with function, economy with effectiveness. In plastic.

Isn’t it great when what you develop changes lives? If you answered ‘yes’, then you might be the one to join our multi-disciplinary team of dedicated engineers. For patients in critical care, we’re designing and developing state-of-the-art systems and disposables for an innovative flushing therapy (in combination with measurements and monitoring). You’ll be working on the mechanical design of the disposable part of our new products. You’ll be expected to find the right balance between functionality, quality, costs and lead-time.


Development is done according to the international medical device product requirements/standards and medical device regulations (US-FDA and EU-MDR). Along with passion and a natural curiosity, we are looking for someone with a wide variety of technical skills and reasoning in analyzing and designing mechanical systems, running tests, improving/resolving product features, and documenting findings.

Your responsibilities:

  • The mechanical design of existing and new products
  • Determine/gather user requirements and translate them into design
  • Support proper Risk Management (e.g., FMEA on safety and technical/reliability aspects)
  • Work on 3D modelling of Haermonics’ products and create 2D work drawings
  • Support the selection and purchase/import of (electro-)mechanical components for all Haermonics’ products
  • Proper filing of all relevant technical documentation
  • Co-create test-plans, co-execute actual tests and create/complete test-reports


What you bring to the team:

  • You have B.Sc. or M.Sc. in Mechanical Engineering Biomedical engineering, Technical Medicine or Industrial Design
  • Preferably 3+ years working experience as a mechanical engineer or similar role
  • Analytical insight and skills in the field of fine mechanics, 2K injection molding, and complex soft plastics extrusion applications
  • You thrive in a small team and combine creativity with a can-do mentality
  • Ideally, you have experience with developing and producing a medical device that successfully received FDA or EU-MDR CE-certification.

What we offer:

Our goal is to save 10,000 lives by 2030. So we’re looking to build a dedicated team that we can count on, so that others can count on us. Besides a driven purpose, joining the Haermonics team will give you:

  • A competitive salary.
  • 28 Days of leave and the possibility to purchase up to 10 extra days off annually
  • Colleagues who are the best and brightest in their field
  • A personal development budget, free training and coaching (after all, remaining “the best and brightest” requires ongoing dedication)
  • A young, dynamic, international, high-tech startup environment, where you will collaborate daily with top-level medical device suppliers
  • Direct access to clinical practices and colleagues in leading academic centers
  • A share package (because our success is your success and we’re looking for long-term committers)


About Haermonics

When it comes to solving important, real-life medical problems, the Haermonics team brings discipline, creativity and extensive testing to each and every elegant solution. Currently conducting a clinical trial in 4 clinics of our innovative post cardiac surgery flushing technique, we’re in the final product development stages, aiming to go to market early 2024.

We are curious by nature. “Is there a better way?” is our daily reflection. Undaunted by the complicated, we understand that in every tangle of complexity, there lies an elegant solution. We strip a problem down to its essence. We simplify to clarify.  Because simplicity inspires action.  Above all, we believe in what we do. Unbound by convention, we are the change we want to see in the world. Viva la evolution.

Read more
Product Manager
The Product Market Fit is everything.

You have a crucial role in the product definition, promotion, distribution and pricing of the Haermonics PureTM device and disposables. We’re not kidding when we say that we can’t do this without you.

You will be working on the international market introduction of our Pure product, that is now being tested in 4 clinics in the Netherlands. You know better than any that crucial for a proper market introduction is product-market fit and market acceptance. And market acceptance doesn’t happen by chance; it will be in your capable hands. We expect an experienced medical technology professional to guide the product launch to success.


Your responsibilities:

  • Translating market demands and user needs into product features
  • Defining/contributing the company/product marketing strategy
  • Assuring an appropriate product-market fit
  • Defining and planning the product road map
  • Ensuring successful market entry
  • Supporting the product development team in translating user & business requirements into product requirements
  • Eventually owning the role of product owner

 

What you bring to the team:

You’re at home with product development of course, but also have experience with market launches and product road maps. Above all, you’re an excellent communicator.

  • You have B.Sc. or M.Sc. in Mechanical Engineering Biomedical engineering, Technical Medicine, Industrial Engineering or Industrial Design
  • +10 years of relevant industry experience, with +5 years of experience in a technical leadership role
  • A quality-oriented mindset with a track record of driving improvements within your organization
  • You are a creative challenge solver with a helicopter view, able to think abstractly and analytically, leading the charge on solving complex cases (with out-of-the-box thinking when required)
  • Strong track record in Product Development, Design Controls and (medical Device) marketing
  • You’re at home working in a small, agile project team and have start-up experience (or at least a start-up mentality)
  • Strong collaboration and stakeholder management skills
  • Knowledge and experience working in a regulated process-driven environment (healthcare industry experience a plus)
  • Excellent English, both written and verbal

 

What we offer:

Our goal is to save 10,000 lives by 2030. So we’re looking to build a dedicated team that we can count on, so that others can count on us. Besides a driven purpose, joining the Haermonics team will give you:

  • A competitive salary.
  • 28 Days of leave and the possibility to purchase up to 10 extra days off annually
  • Colleagues who are the best and brightest in their field
  • A personal development budget, free training and coaching (after all, remaining “the best and brightest” requires ongoing dedication)
  • A young, dynamic, international, high-tech startup environment, where you will collaborate daily with top-level medical device suppliers
  • Direct access to clinical practices and colleagues in leading academic centers
  • Option to join our Share Appreciation Rights plan (because our success is your success and we’re looking for long-term committers)


About Haermonics

When it comes to solving important, real-life medical problems, the Haermonics team brings discipline, creativity and extensive testing to each and every elegant solution. Currently conducting a clinical trial in 4 clinics of our innovative post cardiac surgery flushing technique, we’re in the final product development stages, aiming to go to market early 2024.

We are curious by nature. “Is there a better way?” is our daily reflection. Undaunted by the complicated, we understand that in every tangle of complexity, there lies an elegant solution. We strip a problem down to its essence. We simplify to clarify.  Because simplicity inspires action.  Above all, we believe in what we do. Unbound by convention, we are the change we want to see in the world. Viva la evolution.

Read more