Job Description Summary
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.The Product Engineering Manager leads a team of six engineers in the development of ultrasound products. The role ensures compliance with Design Control standards (ISO 13485, FDA 21 CFR Part 820), manages the Design History File (DHF), and drives cross-functional collaboration with QA, RA, Marketing, and Engineering.
Job Description
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.
GE Healthcare is an Equal Opportunity Employer where inclusion is essential. This means that all decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, or other characteristics protected by law. law.
We expect all employees to live and breathe our behaviors: act with humility and build trust; lead with transparency; Deliver with focus and drive ownership, always with unwavering integrity
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.
Additional Information
Relocation Assistance Provided: No