Systems Quality Engineer

Position Summary:

We are looking for an energetic individual who wants to be part of a growing, entrepreneurial company that is committed to delivering high quality medical products, services, and solutions that meet radiology customers’ needs. Our employees drive our innovation and success by contributing to cross functional projects that enables them to show their potential, ability to stretch, and their growth. Hard work, talent, and proactively demonstrating results are rewarded by career development and advancement opportunities.

The individual will be part of the Research and Development Engineering team with contributing responsibility for the verification and validation of new products being developed.  This person plans, designs and executes complex schedules and test plans, as well as hazard and safety analyses, per the specifications, while adhering to all policies and procedures. They ensure outcomes are measured, data is tracked accurately, and proper documentation meets all compliance requirements.  This person also leads and coaches’ quality engineering team members providing guidance on projects, procedures, and testing.

Position Responsibilities:

Responsible for supporting new product development and process compliance to regulatory requirements. Also responsible for (but not limited to) the following:

• Contribute to new product development in areas of design verification & validation of product requirements, regulatory requirements, specification development, measurable outcomes, hazard and safety analyses and other quality activities necessary to meet hardware/software project objectives.
• Develops complex schedules/resource plans for Verification and Validation activities.
• Plans, designs, and executes complex test plans\procedures for Verification and Validation activities.
• Documents in the appropriate repository all quality deliverables.
• Represents customer perspective in project quality decisions.
• Provides clear scope definition, implements new tools, drives change management, and defines metrics that define successful completion of Verification and Validation activities.
• Provides support for Regulatory agency and internal audits and inspections.
• Duties may also include activities to support the customer complaint process.

Required Skills & Education:

• Bachelor’s degree in engineering (electrical, mechanical, software, cybersecurity, etc.), Imaging Science, or the Clinical domain (preferably in engineering for medical devices) or equivalent.
• 4+ years (6-10 years preferred) of demonstrated engineering skills and leadership in software and hardware quality roles.
• Demonstrated data-driven decision making.
• Excellent attention to detail.
• Demonstrated leadership skills.
• Strong analytical, decision-making and problem-solving skills.
• Excellent written and verbal communication.

Desired Skills:

• Quality Engineering, manufacturing, or service experience within a regulated medical device industry.
• Experience with regulatory audits (ISO 9001, ISO 13485, MDSAP, etc.).
• Quality, Security, AI related certifications (Six Sigma Black Belt or Green Belt, CSQE, CQE, CRE, CISSP, Prompt Engineering, etc.)
• Competent in the use of quality and implementation tools (ex: ADO/MR, PLI, MasterControl, Reliability related, FMEA, fault tree analysis, root cause analysis, fishbone diagrams, DOE, etc.)
• Ability to provide direction for and apply statistical tools to support Verification & Validation activities (ex. Minitab, Reliasoft, etc.).
• Demonstrated knowledge with various automation tools/environments/languages including but not limited to Robot Framework, GIT, Python, Java, Fish/Eye/Crucible, Ghost.