On-Site Systems Engineer - Medical Devices & V&V

Baymar Solutions; Tucson (AZ); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Medical, dental and vision

Disability and life insurance

2 weeks PTO a year

6 paid holidays

PTO carry over upon full-time

Job summary

Baymar Solutions in Tucson, AZ is seeking a Systems Engineer to join a tight-knit team on-site at a client facility. You will define requirements, manage risk, and verify medical device instruments as part of an embedded, full-time role with potential to convert to permanent employment.

The role requires collaboration across quality, operations, manufacturing, and R&D, with a focus on ISO 14971, FDA-regulated environments, and thorough documentation.

Qualifications

• Bachelor’s degree in mechanical, electrical, biomedical, or systems engineering, or a related field.
• 2+ years of systems, mechanical risk, V&V, or design‑assurance engineering. At least 1 year in FDA-regulated medical devices (21 CFR 820 and ISO 13485 environments).
• Working knowledge of ISO 14971 and design controls.
• Written protocols and reports that passed review and audits.

Responsibilities

• Collaborate with quality, operations, manufacturing, and R&D to support engineering changes within medical device quality systems.
• Own risk and requirements for medical device instruments, evaluating design changes for impact to safety and efficacy.
• Assess risk per ISO 14971: hazard analysis, design and process FMEAs, and risk‑control verification.
• Write, execute, and report verification and validation protocols, including test‑method validations.
• Assess design changes for V&V impact; review and draft engineering change orders that release drawings, BOMs, and work instructions.
• Evaluate and determine root causes and resulting dispositions for non‑conforming products.
• Deliver clear and detailed technical presentations, including design reviews, to key project stakeholders.
• Communicate frequently with clients, providing updates on project progress and technical details.
• Ensure accuracy and quality by maintaining a high level of attention to detail in all aspects of the work.

Skills

FDA-regulated experience

ISO 14971 knowledge

V&V experience

Documentation writing

Risk management

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Tools

Jama/DOORS/Polarion

PLM/QMS systems (SAP/Windchill/EtQ)

Job description

Baymar Solutions in Tucson, AZ is seeking a Systems Engineer to join a tight-knit team on-site at a client facility. You will define requirements, manage risk, and verify medical device instruments as part of an embedded, full-time role with potential to convert to permanent employment.

The role requires collaboration across quality, operations, manufacturing, and R&D, with a focus on ISO 14971, FDA-regulated environments, and thorough documentation.