Roles and Responsibilities
- Lead and mentor a team of 6 engineers in the development and support of ultrasound products.
- Ensure adherence to Design Control processes in compliance with ISO 13485 and FDA 21 CFR Part 820.
- Drive larger tasks or cross-functional projects related to our area.
- Collaborate cross-functionally with QA, RA, Marketing, and the rest of Engineering.
- Support the team in audits, Design Control, and technical discussions.
- Be responsible for the DHF.
- Promote continuous improvement in engineering practices and documentation.
- In-depth understanding of key business drivers. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
- Has access to technical skills and analytic thinking required to solve problems.
Required Qualifications
- Master’s degree in Engineering or a related field.
- Minimum 7 years of experience in the medical device industry.
- Strong knowledge of Design Control and regulatory requirements.
- At least 2 years of experience in a leadership role.
- Excellent communication, leadership, and problem-solving skills.
- Experience with project management tools and methodologies.
Desired Characteristics
- Strong oral and written communication skills.
- Ability to analyze and resolve problems.
- Ability to empower the team.
- Collaborative approach.
Our total rewards are designed to unlock your ambition by giving you the drive and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters caring, collaboration and support.