Our mission at Progenity is simple: to help healthcare providers and patients prepare for life. We provide the most advanced molecular technology and the highest levels of service to guide patient care at critical life stages. We continually seek people with the motivation and skills to advance our mission.
As a key member of our Device Development team, the Senior Systems Engineer is responsible for system integration activities across several projects for the development of electronics-based medical devices and test equipment/fixtures. This Systems Engineer translates the voice of the customer and stakeholder needs into system and product requirements, identifies potential hazards and assesses requirements to ensure that the product meets the user/business needs, develops design and process specifications for new hardware and software products, aids in product verification and validation, and provides support in sustaining activities. The expectation for the Systems Engineer is to regularly serve on smaller project core teams, act as a leader of technical excellence, and participate as an agent for continuous improvement within the Systems Engineering function. As such they are expected to help identify tasks/resources to ensure that critical project milestones are met, and systems integration activities are identified and fulfilled.
RESPONSIBILITIES
- Leads system/product-level feasibility and risks assessments.
- Facilitates cross-functional knowledge and experiences to promote the understanding and resolution of in-market and product development issues.
- Responsible for coordination of system-level product development and its integration.
- Serves as a resource to examine system behavior issues and bring to resolution for on-market products.
- Identifies opportunities and drives continuous improvement efforts in the development cycle.
- Applies DFSS best practices on all projects.
- Works on complex issues where analysis of situation or data requires an in-depth evaluation of variable factors.
- Drives software/electrical project timelines and resource needs for device projects.
- Performs other duties as they are identified to support cross-functional teams.
This list of duties and responsibilities is not all-inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.
REQUIREMENTS
- Minimum BS in SWE, EE, CE, CSE.
- 3-5yrs of experience with embedded systems, medical devices preferred.
- 3-5yrs of experience with design for test (DFT).
- Good Project Management skills.
- Working knowledge of product development lifecycle.
- Working knowledge of Medical Device Development Life Cycle and Manufacturing.
- Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485.
- Test / characterization of PCBAs.
- Scripting for automated system testing using Python or a similar language.
- Data analysis, parsing test results, etc.
- Solid documentation and data collection practices related to medical devices.
- Report bugs and feedback to drive continuous product improvement.
- Experience with oscilloscopes, multimeters, function generators, and other test equipment.
- Experience with ECAD programs such as Altium, MentorGraphics, or similar.
- Generate formal test reports and present them to larger technical audiences.
- Experience in writing control software (C#/Python) for custom test equipment supporting novel device development.
- Familiarity with domestic and international regulations and industrial guidance documents (e.g., ISO, FDA guidance, and CE Mark requirements).
- Ability to handle multiple projects and priorities with exceptional organizational and time management skills.
- Recognized for being well organized and self-directed with strong interpersonal skills and with an ability to communicate to people at all levels of the organization and lead with influence.
- Proactive, forward-thinking, and creative with high ethical standards, leadership skills, and the ability to influence others to achieve successful outcomes and meet timelines.
- Ability to function efficiently, effectively, and at times independently in a fast-paced, changing environment.
- Strong team player aligned with Progenity Corporate Values.