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Product Development
Project & Program Management
R & D
Medical Devices
MedTech

Darius Aleksiejus

Project Management professional with technical background bringing 10+ years of experience developing new products, implementing development processes and effectively managing budgets and timelines. Blend of technical and leadership experience helps building and guiding lean cross-functional teams that solves complex issues for organizations.

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10+
Years in Product Development
Class I - III
IVD to AIMD experience
EU & US
Regulatory markets
Product Portfolio
Clinical Trial Assays Clinical Trial Assays
Sleep Apnea AIMD Sleep Apnea AIMD
Intramyocardial Catheter Intramyocardial Catheter
Healthcare Consumables Healthcare Consumables
Healthcare Platform Healthcare Platform
Consumer Goods Consumer Goods
Percutaneous Implant Percutaneous Implant
Hearing Aids Hearing Aids
Darius Aleksiejus
About

Bridging engineering rigour with commercial delivery

I work as a self-employed Project/Programme Manager based in Vilnius, Lithuania. With over a decade of experience developing and managing different types of products (mainly Medical Devices) and processes related to development, I embed directly in client teams on a project or interim basis. My experience spans the full product development lifecycle, from early-stage R&D and design control implementation through to regulatory submission. I have a track record of building medical devices stemming from Class I to Class III.

My experience was built from working with such companies as Cochlear, Baxter, Celyad and most recently with CellCarta. I have a strong technical background, having started my career as a Development Engineer before transitioning into project management. This blend of technical and leadership experience allows me to effectively communicate with both engineering teams and business stakeholders, ensuring that projects are not only technically sound but also commercially viable.

Open to support your projects remotely, in a hybrid setting or on-site. If you need hands-on, someone who can step in, identify bottlenecks, optimize processes or simply build the project from scratch — get in touch.

Project & Programme Management Design & Development Lifecycle Project Planning OPEX D&D Quality Management System (QMS) Product Development CAPEX ISO 14971 Active Implantable Medical Devices (AIMD) Design Controls Design History File (DHF) ISO 13485 Cross-functional Teams Risk Management V&V IVD / Clinical Trial Assays (CTA) Stakeholder Management KPI & Performance P&L Management PRINCE2 AGILE Waterfall, Stage-Gate Clinical Trial Assay (CTA) Intramyocardial catheter Healthcare Consumables Healthcare Platform Hearing Aids Consumer goods
Services

How I can help

I take on project-based and interim roles across the full R&D lifecycle — from concept & project set-up, design control implementation through V&V, regulatory submission, and launch.

01
Project & Programme Management

Scope, timeline, resource, and budget implementation across single or multiple concurrent development projects. I can own P&L, product delivery and report directly to stakeholders.

02
QMS, DHF & Design Controls

Setting up QMS and implementing ISO 13485-compliant design control processes. Ensuring DHF completeness and stage-gate readiness from project kick-off through to product launch.

03
Operational Process Improvement

Identifying gaps in product development frameworks and driving corrective actions. Spearheading process optimization initiatives — from stage-gate implementation to D&D operational framework refinement — eliminating waste and enhancing efficiency.

04
Verification & Validation

Overseeing V&V activities, test method development, feasibility studies, and prototype evaluations. Defining test strategies aligned to regulatory requirements and design inputs.

05
Stakeholder & Client Management

Acting as the single point of contact between your team and external clients or sponsors. I manage expectations, lead project meetings, and keep communication structured and on schedule.

06
Product Development

Available to step in as Project/Programme Manager, R&D Lead, or Product Owner for companies navigating critical development phases, team scale-up, or product pivots.

Experience

Career timeline

Oct 2025 — Present
D&D Program Manager
CellCarta · Antwerp, Belgium (Remote)

Managing a high-profile Clinical Trial Assay (CTA) D&D project portfolio across multiple cross-functional teams — scope, timeline, budget, and ISO 13485 QMS compliance. Leading teams through Design Control stage-gates, conducting design reviews per the D&D Plan, and ensuring DHF completeness. Contributed to gap analsysis and framework adaptation for companion diagnostics (CDx) devices.

2023 — Present
Self-Employed D&D Programme Manager
Independent Consultant · Vilnius, Lithuania

Providing R&D project and programme management consultancy for medical device and consumer-goods companies. Services span scope and timeline definition, OPEX budget management, governance set-up, CM selection strategy, and process optimisation — with a focus on operational excellence throughout the product development lifecycle.

Apr 2024 — Dec 2024
Product Owner
Adroiti Technologies · Vilnius, Lithuania

Product owner for a regulated digital health solution (APP & WEB) targeting the US elderly care market. Maintained the product roadmap, managed the feature backlog, and drove agile (CI/CD) delivery. Responsible for stakeholder alignment and data-driven prioritisation.

Dec 2020 — Mar 2024
Project Manager
Cochlear Technology Centre (CTC) · Mechelen, Belgium

Managed end-to-end project activities for the Design & Development, V&V, prototyping, and manufacturing of a Class III Active Implantable Medical Device — firmware, hardware, packaging, and sterilisation. €10M budget responsibility. Led a cross-functional team of 7. Ran design reviews in line with ISO 13485 design control procedures. Delivered a fully verified and validated AIMD within agreed scope, formally closed with Tech-Transfer including full V&V and design documentation sign-off.

Jan 2017 — Dec 2020
Principal R&D Engineer
Baxter · Braine-l'Alleud, Belgium

Technical lead for healthcare consumable D&D, coordinating globally distributed teams. Led exploratory and innovation projects from concept through prototyping and validation. Contributed to the 5-year Global Business Unit product and technology roadmap.

Jan 2015 — Dec 2016
Product Development Engineer
Celyad · Mont-Saint-Guibert, Belgium

Designed and developed an innovative endocardial injection catheter for Acute Myocardial Infarction (AMI) treatment, resulting in EU patent application (EP3254723). Conducted feasibility studies, coordinated suppliers, contributed to QMS implementation, and performed risk analysis throughout the development lifecycle.

2011 — 2014
MSc Biomedical Engineering
Vrije Universiteit Brussel (VUB) / Universiteit Gent (UGent) · Belgium

Biomedical product development, FEA simulation, QMS, risk analysis, lean management, and EU medical device standards (EN ISO 13485, 93/42/EEC).

Contact

Get in touch

Whether you have a specific project in mind or want to explore how I can support your team, I'd be glad to hear from you. I typically respond within one business day.

  • daleksiejus@gmail.com
  • +370 628 97 036
  • linkedin.com/in/dariusaleksiejus
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