Datascope Corp. is seeking a Senior Systems Engineer to provide technical input to a team of systems and cross-functional engineers. The role involves supporting the development and improvement of electromechanical medical devices, ensuring compliance with regulatory requirements, and driving innovation in systems engineering practices. This is a remote position focused on scalability and maintenance of on-market devices.
Requirements
- BS in Systems, Biomedical, Electrical, or Software Engineering
- 8+ years of related experience
- MS or PhD in Systems, Biomedical, Electrical, or Software Engineering
- Strong track record of supporting the development of electromechanical medical devices
- Proficiency in using tools such as JAMA
- Understanding of medical device development methodologies and regulatory requirements
- Excellent communication and interpersonal skills
- Knowledge of requirements development, traceability, and allocation
- Knowledge of medical device risk management, including ISO 14971:2012; Knowledge of ISO 13485:2016.
- Experience with Requirements Management Tools (such as JAMA)
- Strong organizational and technical writing skills
Benefits
- Health, Dental, and Vision insurance
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Originally posted on Himalayas
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