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Lead Systems Engineer
2 months ago
Sign-On Bonus: This position is eligible for a $5,000 sign-on bonus.
Company Overview: Cirtec Medical is a leader in the design and manufacturing of complex medical devices. We specialize in providing a comprehensive suite of vertically integrated services, focusing on advanced technologies such as neuromodulation, implantable drug delivery, and cardiac rhythm management. Our expertise enables us to support our clients from concept through to full production, including assembly, packaging, testing, and sterilization.
Team Collaboration: As part of our Engineering team, you will collaborate closely with Operations, R&D, and Purchasing. Your role will involve the design, development, documentation, and validation of innovative customer products, as well as modifications to existing products. You will define requirements, timelines, and deliverables, with a focus on prototypes, process development, design verification, and clinical builds.
Position Summary: The Senior Systems Engineer will oversee system-level development and implementation of electronic and software designs for Class II and III medical devices. You will work within a multidisciplinary engineering team, ensuring high-quality and timely product introductions. This role requires a proactive individual capable of managing multiple projects efficiently while maintaining a positive and collaborative attitude.
Key Responsibilities:
- Develop requirements and engineering specifications throughout the product lifecycle.
- Apply medical development standards such as IEC 62304 and ISO 13485.
- Ensure compliance with hardware and software requirements to optimize performance and reliability.
- Conduct detailed design analyses and regular design reviews with engineering teams.
- Collaborate with program managers to create and manage development and project plans.
- Lead the creation of risk management documentation, including Failure Mode Effects Analysis.
- Maintain comprehensive documentation for medical product Design History Files.
- Participate in product development meetings and design reviews.
- Assemble hardware for testing and maintain design history files.
- Provide insights to enhance medical device design and testing outcomes.
Qualifications:
- Bachelor's degree in a STEM field and a minimum of 5 years of relevant experience.
- Experience in engineering environments, particularly in medical device manufacturing.
- Strong attention to detail and ability to maintain accurate records.
- Familiarity with Quality Control principles and methodologies.
- Excellent communication and interpersonal skills.
- Analytical problem-solving abilities.
- Knowledge of Agile development methodologies.
- Fluency in English, both written and spoken.
- Experience with active and passive implantable devices is preferred.
What We Offer:
- A dynamic work environment.
- Paid time off and a 401(k) retirement plan with company matching.
- Training and career development opportunities.
- Comprehensive health care and wellness programs.
Working Environment: The role is performed in an office setting with moderate noise levels.
EEO Statement: Cirtec Medical Corporation is an Equal Opportunity Employer, committed to diversity and inclusion in the workplace.
