Senior Medical Device Systems Engineer
1 week ago
About the Role
As a Senior Medical Device Systems Engineer at Terumo Blood and Cell Technologies, you will play a key role in translating user needs and business requirements into product specifications that drive design, implementation, and testing of medical devices used for blood collection and blood components.
This senior-level position requires extensive knowledge of quality management systems, including ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601. You will be responsible for leading multidisciplinary design efforts to ensure seamless integration and timely delivery, collaborating globally with mechanical, electrical, and software teams to achieve functional and reliability goals.
Key Responsibilities
- Translate user and business requirements into detailed product requirement specifications and design specifications.
- Apply design controls to ensure compliance with regulatory requirements and industry standards.
- Lead design changes to implement and enhance features for blood collection platforms, ensuring quality and regulatory compliance.
- Independently conduct technical reviews with stakeholders to meet project design objectives.
- Perform failure analyses to prioritize testing and ensure design completeness and product quality.
- Communicate and collaborate effectively to align teams and streamline workflows.
- Support design transfer to enable successful commercialization of complex products.
Requirements
To succeed in this role, you will need:
- A Bachelor's degree or equivalent in Engineering, preferably in Biomedical Engineering or a related field.
- Minimum 7-9 years of engineering experience, with 4+ years in the medical device field.
- Proficient in configuration management, design history files, and test methods for medical devices.
- Knowledgeable in evaluating designs for serviceability and manufacturability, and conducting risk analysis for defects.
- Familiarity with requirements management tools like Doors, Windchill RV&S, and test management tools like ALM.
Compensation
The estimated salary for this position is $120,000 - $160,000 per year, depending on experience and qualifications. This range is based on national averages and may vary depending on location and other factors.
Benefits
We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. We are an equal opportunity employer and welcome applications from diverse candidates.
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