Senior Project Engineer - Hardware

About us
Neocis is an established start-up revolutionizing dentistry with Yomi, the first, and only FDA cleared robot for assisted dental surgery. The company collaborates closely with leading clinicians to develop innovative technologies that help advance patient care and improve quality of life. Based in Miami, Florida. Neocis is venture-backed with funding from several prominent investors.
What's in it for you?

• You'll thrive in our innovative and collaborative environment
• Make an immediate impact on life-changing technology
• Avoid silos and "not my job" mentality in our smaller, fast paced, startup environment
• We offer sabbatical, parental leave and unlimited PTO policies
• Generous 401K plan with 4% company match
• Comprehensive benefits package that includes medical, dental and vision.

The role: Senior Project Engineer - Hardware
With a focus on Hardware projects, you'll play a key role in the development of our next generation surgical robots. You'll be responsible for coordinating various aspects of a project from requirement gathering, risk analysis, document deliverables to verification, validation and design transfer activities as required by the project while maintaining clear communication of project status to stakeholders and ensuring projects adhere to the quality system requirements.
What you'll do:

• Own and maintain design plans for various projects on the Hardware Engineering team.
• Ensure relevant projects follow design controls per company SOP.
• Perform quality control on the project throughout development to maintain the standards expected.
• Align cross functional efforts to achieve project objectives.
• Assist in planning and coordinating verification and validation activities.
• Maintain a clear picture of project status at all times.
• Frequently communicate project status to the leadership team.
• Gather and present data to help the leadership team to take effective decisions when presented with multiple options for how to progress with the project.
• Act as the interface between R&D teams and Manufacturing and Quality teams.
• Interact with Product Management/Marketing/Sales, Quality and customers to obtain feedback on new product designs and necessary changes to existing designs in office, phone or cadaver lab settings.
• Periodically gather and review field data and help ensure the engineering team conducts technical investigations in a timely manner.
• Support generation of project deliverables such as DI, DO, Risk analysis, Trace matrices, etc.
• Drive the development of FMEAs in partnership with the engineering and quality teams.
• Identify gaps between user/product requirements and system requirements. Contribute to refining requirements definition
• Develop test plans and contribute to defining and exercising verification and validation protocols.

What you'll bring:

• Bachelor's degree in Engineering (Electrical, Mechanical, Biomedical or related field) with 4+ years of experience in project management or Master's Degree in Engineering with 3+ years of project management experience.
• Previous experience in medical devices with surgical robots preferred.
• Strong familiarity with ISO 13485, 21 CFR 820 and IEC 60601
• Strong communication skills required
• Strong familiarity with project management software tools, methodologies, and best practices
• Experience guiding projects through the full life cycle
• Strong interpersonal skills
• Proven ability to complete projects according to outlined scope, budget, and timeline
• Measure project performance to identify areas for improvement

What else?
This job operates in a professional office environment.

• This position requires the regular use of software packages for project management (e.g. Asana, Jira,)
• Prolonged periods working on a computer.
• Frequent exposure to moderate noise

This is a full-time position. This position occasionally requires long hours and weekend work.
This position requires up to 10% travel. Frequently travel is outside the local area and overnight.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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