Senior Research And Development Engineer

Skills Alliance Location Not Available

Stellenbeschreibung:

Senior Research And Development Engineer

This opportunity is with a growing European medical device innovator focused on developing next‑generation, minimally invasive Class III cardiovascular technologies . The company is advancing implantable solutions designed to improve treatment options for patients with structural heart disease , including novel approaches to valve repair. Supported by strong investment, an international team, and active clinical development across Europe, the organisation offers a hands‑on engineering environment where ideas progress rapidly from concept to prototype and into evaluation. Based in Baden‑Württemberg , the company provides a collaborative culture, modern facilities, and an excellent quality of life close to major medical and research hubs.

Responsibilities

Lead the design, prototyping, and development of Class III cardiovascular/structural heart devices.
Develop engineering solutions to meet clinical and anatomical requirements.
Create CAD models, drawings, and supporting documentation.
Plan and execute verification and validation testing; analyse results and drive design improvements.
Develop and maintain project plans across design, testing, and regulatory workstreams.
Lead risk management activities (DFMEA, PFMEA) in compliance with ISO 14971.
Support design transfer and preparation for clinical evaluation.
Collaborate closely with Quality, Regulatory, Manufacturing, and Clinical teams.
Prepare specifications, protocols, and technical reports in line with design control requirements.

Requirements

Bachelor’s or Master’s degree in Biomedical, Mechanical, or related engineering field.
5+ years’ experience in medical device R&D, preferably Class III implantable devices.
Background in structural heart, cardiovascular, endovascular, or interventional technologies.
Proficiency in CAD (SolidWorks preferred).
Experience with design control, verification/validation, and risk management (ISO 14971).
Strong understanding of materials and manufacturing processes for implantable devices.
Excellent English communication skills; ability to work onsite daily.
German language skills or willingness to develop working proficiency.