Our client design and supply medical solutions for use in both the hospital and the home. They are committed to improving performance in healthcare with their products and as such are continually developing new technology. Currently in a peak period of work they require a Design Owner/Technical Product Engineer to come on board to support the on-going activities.
Technical Product Engineer – medical devices
SCOPE OF WORK:
Support work for technical documentation of different product types for medical device product development to meet external and internal standards. Work to include establishing design requirements, writing risk reports, doing statistical analyses of technical data etc.
This is to supplement the current design owner team.
Delivery of work performed in projects in accordance to the clients processes and in accordance with the projects’ design and development plan.
Quality management system is based on ISO13485 and 21 CFR 820 (QSR).
REQUIRED SKILL AND COMPETENCE:
- Relevant Masters degree or equivalent working experience
- Minimum 3 years experience from R&D in medical device industry
- Knowledge and experience in design control and risk management including requirements in external standards and regulations (ISO 13485, ISO 14971, 21 CFR 820).
- Performance driven team player with a high customer focus and a result oriented mindset. Used to deliver high quality work within given deadlines.
- Good communication skills, strong problem solving capabilities and good ability to structure and prioritize assigned tasks.
- Experience with risk assessments, design reviews and design testing
ESTIMATED TIMELINE AND HOURS OF WORK:
35 hours/week, (7 hours per day)
Temporary position for up to 6 months with review after 6 months.
To apply for the Technical Product Engineer – medical devices role:
Cover notes supporting your application are welcomed. On this occasion LiCa Scientific is acting as an employment business.
Please email email@example.com with your most up to date CV and a cover letter.