Design Control Engineering
Senior Consultant – R&D Design Control
MSc Mechanical Engineering
Available for: Full time, part time, tasks
- Medical Device Development:
- Syringes, injectors, pumps, IVD and monitoring systems including reagents, surgical instruments.
- Mechanics, electronics, software and connectivity.
- Design Control and QA:MDR, ISO 13485, 21 CFR820.30.
- Risk analysis: ISO14971 -FMEA.
- Experience with Root Cause Analysis, data mining and trend spotting.
- Lab testing and analysis, Design of Experiments.
- Test methods and measurement uncertainty:
ISO 2859, ISO 3951, ISO 17025, BIPM, GUM.
- Basic plastic material knowledge.
- Extensive experience working cross functionally with pharmacist and chemists to find solutions crossing the border between device physics and chemistry and quality compliance.
- Thorough understanding of injection moulding, its strengths and limitations.
- Extensive experience working internationally with suppliers including CMOs and test houses including data review.
- Decision supportsystem:
- Device and SW concept, design and verification.
- Clinical data structure, set up, coordination and analysis.
- QA responsible.
- Complex electro-mechanical inhalation drug delivery system:
- Specification, risk management, system integration, testing, data analysis and design adaptions.
- Industrial and Man Machine Interfacedesign.
- Comprehensive revision of mass-produced Primary Packaging.
- Revision of:
specifications, design control, quality specifications/agreements, risk management and test methods to comply with user needs, process capability, quality and regulation.
- Major cost savings achieved.
- Revision of:
- IVD blood testing regarding coagulation.
- Device design and commercial launch.
- Several patents granted. Received Danish Design Award.
- Dosing test method for pen injectors and infusion pumps.
- Invented test method.
- Used in ISO 11608 Needle-based injection systems.
Software, Standards & Regulation
- Excel, experienced user.
- Minitab, basic user.
- Standards & Regulation Extensive experience working according to and under:
- ISO 13485 (Design Control), ISO 14971 (Risk) and related standards.
- MDR, FDA 21 CFR820.30.
He is systematic, analytic, QA minded and has an innovative and proactive mindset.
He is a perfectionist with an eye for details and correctness, however pragmatic regarding what is needed to achieve objectives.
He has a strong system understanding and of the physics involved.
He meets people with positive expectations and establish respectful, productive and efficient relationships.