Senior MedTech Quality Engineer — CAD

Project Manager – Ceramic Implants (Medical Technology)
Location: Germany (flexible – on‑site & remote options available)
Employment type: Full‑time, permanent

---

About the Company

We are a leading, globally‑recognized medical‑technology company dedicated to advancing patient care through innovative, high‑quality implant solutions. Our portfolio spans orthopaedics, spinal, and dental applications, and we are now expanding our ceramic‑implant programme. Join a fast‑growing, research‑driven environment where cutting‑edge science meets rigorous regulatory standards.

---

Role Overview

As Project Manager – Ceramic Implants, you will own the end‑to‑end delivery of new ceramic‑based implant programmes. You will coordinate multi‑disciplinary teams (R&D, materials science, design, clinical, regulatory, quality, manufacturing, and marketing) to bring concepts from early design through to clinical evaluation and market launch, ensuring full compliance with ISO 13485 and other applicable regulations.

---

Key Responsibilities

Area	Responsibilities
Project Planning & Execution	• Define project scope, milestones, budgets, and resource plans. • Develop detailed work‑breakdown structures and Gantt charts. • Track progress, manage risks, and implement corrective actions.
Cross‑Functional Coordination	• Lead daily/weekly steering meetings with R&D, engineering, clinical, regulatory, and supply‑chain teams. • Facilitate clear communication and decision‑making across all stakeholders.
Regulatory & Quality Assurance	• Ensure all activities comply with ISO 13485, MDR (EU), FDA QSR, and internal SOPs. • Oversee design‑control documentation, risk assessments (ISO 14971), and verification/validation plans.
Product Development	• Guide concept generation, feasibility studies, and prototype testing for ceramic implants. • Supervise design reviews, DFMEA, and material‑selection studies (e.g., alumina, zirconia).
Clinical & Evaluation	• Coordinate pre‑clinical testing (biocompatibility, mechanical testing) and clinical trial planning. • Manage relationships with CROs, KOLs, and external research partners.
Budget & Reporting	• Own project financials, forecast expenditures, and report status to senior management. • Prepare executive dashboards, KPI reports, and post‑project lessons learned.
Leadership & Mentoring	• Coach junior project staff and foster a collaborative, high‑performance culture. • Promote continuous improvement and best‑practice sharing across the portfolio.

---

Required Qualifications

Category	Minimum Requirements
Education	• MSc or BSc (or equivalent) in Biomedical Engineering, Materials Science, Mechanical Engineering, or a related technical field.
Experience	• ≥ 5 years of project‑management experience in medical‑device development, with a focus on ceramic or hard‑material implants. • Proven track record delivering products through the full design‑control lifecycle (concept → market).
Regulatory Knowledge	• Deep familiarity with ISO 13485, ISO 14971, MDR (EU), and FDA QSR. • Experience preparing design‑control documentation and regulatory submissions.
Technical Skills	• Strong understanding of ceramic materials (e.g., alumina, zirconia, glass‑ceramics), machining, surface‑treatment, and mechanical testing. • Proficiency with project‑management tools (MS Project, JIRA, Smartsheet, or equivalent).
Languages	• Excellent written and spoken German and English (C1 level or higher).
Soft Skills	• Outstanding communication, negotiation, and stakeholder‑management abilities. • Analytical mindset with a data‑driven approach to risk and decision making. • Ability to thrive in a fast‑paced, matrix‑organization environment.

---

Desired (but not mandatory)

• PMP, PRINCE2, or equivalent project‑management certification.
• Experience with additive manufacturing or 3D‑printing of ceramics.
• Publications or patents related to ceramic biomaterials.

---

What We Offer

• Competitive salary + performance‑based bonus.
• Comprehensive benefits package (health, pension, mobility allowance).
• Flexible working hours and hybrid work model.
• State‑of‑the‑art labs and access to cutting‑edge manufacturing facilities.
• Continuous learning budget, conference attendance, and professional‑development support.
• Opportunity to shape the future of ceramic implant technology and make a tangible impact on patient outcomes worldwide.

---

Application Process

1. Submit your application (CV, cover letter, and any relevant publications/patents) via our careers portal: [careers.medtech‑leader.com].
2. Initial screening – HR will review qualifications and schedule a brief phone interview.
3. Technical interview – Deep‑dive with R&D and Quality leadership on project experience and ceramic‑technology expertise.
4. Leadership interview – Assessment of communication style, stakeholder management, and cultural fit.
5. Final interview & offer – Discussion with senior management and HR for compensation & start‑date alignment.

We value diversity and encourage applicants of all backgrounds to apply.

---

Ready to lead the next generation of ceramic implants?
Apply today and become a pivotal part of our innovative MedTech journey!