Product Development Manager - IVD

Job description

“It doesn't make sense to hire smart people and tell them what to do; we hire smart people so they can tell us what to do.” STEVE JOBS

Dutch technology, global impact

SPEKTRAX is moving fast. We are looking for new colleagues who don't ask us what to do but who will actively help us achieve our goals. Are you interested in being part of something big? Want to change the world for millions around the globe by providing new, faster and reliable diagnostics? This is your chance to not just make a tremendous impact on a national level, but on the global health issues that we are currently all facing. Ready to join Spektrax?

Your personal mission 

To make sure we have a ‘smooth’ path to bringing our test to the market, we are actively looking for our Product Development Manager. You will be responsible for a multidisciplinary product including consumables, integration with existing hardware, data modelling and machine learning. We need to be able to trust you to deliver and be self-propelling. Even though we never really know what the day will bring, we do have some key responsibilities that we would like you to take upon:

  • Providing project management and hands-on support to the technical, analytical and clinical validation; quality control and assurance, bioinformatics, regulatory, and manufacturing aspects. Compliance according to ISO 13485 and other relevant standards.
  • Provide leadership in the development and coordination of a multidisciplinary team, defining key deliverables, milestones, dependencies, according to the Design and Development plan.
  • Supervise creation of design control documentation that meet standards required for inclusion in required regulatory dossiers.

You will also be working closely together with our cross-functional teams to ensure alignment on a clear roadmap. You will be involved in a lot of what is happening in the company so confidentiality and discretion are crucial characteristics we are looking for.

Job requirements

About you 
To make sure you are the high energy colleague with the required qualities, you should maintain a certain skill-set. We’ve listed them for you, so you can make sure you check all the boxes.

  • Strong knowledge of development and validation of diagnostics products ML and data structures
  • You’ve finished your degree in Life Sciences, Analytical Chemistry, Molecular Biology, (Bio)informatics or similar
  • 8+ years of experience in a comparable role.
  • You’ve gained this experience in a start-up or scale-up environment.
  • You are well-structured and precise.
  • You have great project management skills
  • Ambition to lead a team.
  • You are in it to make a change!

The SPEKTRAX culture
We have a very open and transparent way of working and we don't believe in a very hierarchical structure. Since every day in the SPEKTRAX office is different, it would be impossible to give you all the details of your job description. If you are in for variation, leaving your mark in our fast-moving organisation and working together as a real team, then SPEKTRAX is definitely the place for you. Freedom and responsibility are key in our proactive and independent workplace.

About us

SPEKTRAX was founded in April 2020 with one goal: to help the world deal with virus crises such as the COVID-19 with an innovative, ultra-rapid, reliable testing method. We aim to get our diagnostics solution available as soon as possible. Validation & certification processes are currently ongoing and we are looking for the right people to help us get there.