(Advanced / Senior) Project Engineer for Systems Engineering

Description

The company is based in Waldkirch, Germany, and has been part of a Munich-based group since 2022.

For more than 25 years it has developed and sells innovative medical technology for intraoperative neuromonitoring and neurostimulation.

You will work in interdisciplinary development teams on the full device lifecycle, from early concepts to launch and ongoing engineering.

Responsibilities

• Take charge of systems engineering work at every stage, from early concept to market launch and sustaining engineering.
• Define, analyze and keep system requirements current, with full traceability across design, verification and validation.
• Bring engineering, quality, regulatory, clinical and manufacturing colleagues together to move work forward.
• Assess technical concepts, system architectures and design options for performance, reliability and patient safety.
• Organize risk management, design reviews, verification and validation work, and technical assessments.
• Help prepare regulatory submissions and compliance work under MDR, FDA and other applicable rules.
• Manage technical risk, lead problem-solving, and keep projects on track for scope, schedule and quality.
• Act as a technical expert and mentor within the team.

Requirements

• A Master's degree in physics, medical engineering, electrical engineering, mechanical engineering or a closely related technical or scientific field.
• Several years of experience in medical device development, systems engineering or R&D.
• A record of leading complex medical device projects across the full product lifecycle.
• Strong skills in requirements engineering, design control, verification and validation, and risk management.
• Solid knowledge of medical device regulations and standards, including MDR and FDA requirements.
• Strong analytical, technical and problem-solving skills, and the ability to work well in multidisciplinary teams.
• Clear communication, stakeholder management and project leadership.
• Fluent English. German language skills are an advantage.
• Preferred: experience with FDA submissions, clinical evaluation, usability engineering, human factors engineering, electrical or electromechanical systems, and technical leadership in cross-functional teams.
• Preferred: enthusiasm for innovative medical technology and interest in intraoperative neuromonitoring, neurosurgery and spine surgery, thyroid and ENT surgery, neurophysiological monitoring, and signal acquisition and measurement systems.

Conditions

Flexible working hours.

Based in Waldkirch, Germany, with an international team.

The company welcomes applicants regardless of background.

Benefits

• 30 vacation days, plus December 24 and December 31 off.
• Regular team and company events.
• An internal company fitness program.
• Training and continuing education opportunities.