
Chief Medical Device Design Expert
3 days ago
Advanced Medical Technology Lead
We are seeking a highly skilled Lead Mechanical Design Engineer to take a central role in the creation, development and validation of advanced medical technologies. This position requires a broad technical background bringing together expertise in mechanical, mechatronic, electronic and manufacturing disciplines to deliver innovative compliant and high-performing solutions.
Key Responsibilities:
- Shaping product requirements into detailed design specifications
- Selecting materials and manufacturing methods
- Feasibility assessments and proof-of-concept builds
- Driving continuous improvements in design and production processes
- Managing multi-disciplinary project teams
- Applying structured project management practices
- Leading risk management activities such as PHA FTA and FMEA
- Oversight of problem-solving activities and supplier engagement
- Providing guidance across the full product lifecycle
Requirements:
- Bachelor's or Master's degree in Mechanical or Biomedical Engineering or equivalent
- 6–9 years' experience in medical device design including at least 5 years leading mechanical design teams
- Experience working on both capital equipment and disposable components within medical technology
- Strong knowledge of engineering principles root cause analysis and design documentation
- Skilled in GD&T Design for Six Sigma DfSS DOE and statistical analysis
- In-depth understanding of materials manufacturing processes and design for manufacturability/assembly
- Demonstrated leadership with clear accountability for deliverables and team outcomes
- Excellent analytical problem-solving and decision-making skills
- Strong communicator with experience leading cross-functional project teams
- Knowledge of quality and regulatory standards EN ISO 13485 MDR FDA CFR 820
- Familiar with product development processes such as Stage-Gate or PDLC
- High attention to detail quality mindset and strong documentation practices
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