Senior Systems Engineer
3 weeks ago
The Senior Systems Engineer will be responsible for the system-level development and implementation of electronic and software designs for Class II and III medical devices. This role will work closely with a multi-disciplinary engineering team to ensure high-quality and on-time product introductions.
Key Responsibilities
- Create requirements, engineering specifications, and tests during the product development life cycle
- Apply medical development standards, such as IEC 62304, ISO 13485, and ISO 14971
- Ensure that all hardware and software requirements and specifications are met, and that all elements are developed to maximize performance, reliability, and serviceability within the project schedule and budget
- Perform detailed design analysis and conduct regular design reviews with hardware and software engineering teams
- Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development
Requirements
- Bachelor's degree in a STEM engineering discipline (preferred) and 5 years of experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
- Meticulous attention to detail, including ability to maintain accurate records and traceability
- Experienced with Quality Control principles and methodology
- Good Communication and interpersonal skills
- Analytical reasoning and problem-solving
- Experience in developing requirements, engineering specifications, procedures, and team player and goal-oriented
What We Offer
- A fast-paced work environment
- Paid time off
- 401(k) retirement savings with a company match
- Clean, well-lit production areas
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives, and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs
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