Principal Systems Engineer, Development
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Job Description
Principal Systems Engineer leading the design and development of medical devices for a healthcare company. Mentoring junior engineers and managing large-scale development efforts across functions and locations.
Responsibilities:
- Define, design, and lead the overall development of system architecture, design control elements, and integration of new product development efforts
- Interface directly with key opinion leaders, key customers, and end-users to lead the translation of user needs into effective system requirements, ensuring compliance with current and emerging industry standards, and overseeing end-to-end traceability between user needs, requirements, test, and risk
- Ensure the safety, reliability, and performance of the complete system and sub-systems, considering elements like human factors, biocompatibility, sterilization, and design tradeoffs to arrive at detailed product level and functional specifications
- Engage in risk management activities for new product development in compliance with ISO 14971
- Provide expertise and conduct comprehensive verification and validation of design outputs to ensure the final product meets the intended design and performance specifications
- Manage complex and large-scale development efforts with external partners to achieve business objectives
- Guide technical cross-functional project teams on multiple new product design and development projects, successfully influencing stakeholders
- Develop and maintain design history file and related documentation
- Collaborate with Program Management to provide clear updates on project status, technical risk, and factors impacting program success
- Support product launches, clinical, and commercial use of existing and new products
Requirements:
- 10+ years of experience (or equivalent combination of experience and education)
- In-depth knowledge of medical device development, system engineering principles, and relevant technologies.
- Strong understanding of FDA regulations and international standards for medical devices.
- Proven experience in conducting risk assessments and implementing mitigation strategies in compliance with ISO 14971.
- Demonstrated ability to manage complex development efforts, including coordination with external partners.
- Effective leadership skills to guide and mentor less senior team members, with the ability to influence stakeholders.
- Exceptional communication and interpersonal skills, with the ability to collaborate across functions and geographical locations.
- Proficient in developing and executing comprehensive verification and validation plans.
Benefits:
- Comfortable and productive working in and contributing to small engineering teams.
- Periodic travel, such as supplier visits, can usually be well planned in advance.
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