Electrical Engineer for Medical Device Development
1 week ago
We are seeking an experienced Electrical Engineer to join our team as a Medical Device Design Quality Engineer in Southborough, MA. As a key member of our R&D team, you will be responsible for ensuring the highest quality design and development of vascular treatment catheters.
About the Role:
- Lead Design Assurance activities throughout the product life cycle
- Provide expertise in Risk Management, Design Verification/Validation, Test Method Validation, and Process Validation
- Apply systematic problem-solving methodologies to resolve quality issues
- Stay current on regulatory requirements and standards for medical device development
- Guide engineering team members and ensure adherence to design controls
- Support complaint handling and CAPA processes as needed
- Collaborate with R&D to develop project protocols and solutions
- Work with suppliers and supplier quality teams to ensure product quality
- Develop and implement appropriate test methods and validations
- Oversee statistical methods for design and process optimization
- Ensure compliance with industry standards and best practices
- Perform additional responsibilities as needed for project success
- Be onsite at our Southborough, MA facility daily
About You:
- BS in science or engineering with 5+ years of experience in quality management within medical devices or life sciences
- Preferred background in electrical engineering, with experience in US Class III medical devices
- Experience in cardiac electrophysiology devices is a plus
- Strong leadership skills with the ability to manage and guide teams
- Expertise in risk management, design verification and validation, and test method validation
- Knowledge of process validation and preparation
- Proficient in statistical methods and design controls
- Ability to solve complex problems and make data-driven decisions
- Strong communication skills, able to write and speak clearly across organizational levels
- Experience working through the entire product life cycle
- Familiarity with protocols and compliance standards
- Efficient in planning, prioritizing, and organizing tasks and team activities
The Perks:
- Opportunity to work with cutting-edge Class III medical devices
- Growth-focused company with multiple ongoing projects
- Hands-on experience in the medical device field, especially in cardiac technologies
- Potential for career advancement and skill development
- Collaborative and supportive work environment
- Strong company culture with a focus on employee recognition and appreciation
- Exposure to diverse aspects of the product life cycle and regulatory standards
- Opportunity to contribute to the success of innovative medical solutions
- A fast-paced, dynamic work atmosphere with plenty of learning opportunities
Salary Range: $120,000 - $150,000 per year, depending on experience. We offer a comprehensive benefits package, including health insurance, 401(k) matching, and paid time off.
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