Systems Engineer

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 is seeking a Systems Engineer in Tucson (AZ). As part of our tight-knit team, you will play a crucial role in defining requirements, managing risk, and verifying medical device instruments, embedded full-time with a client’s engineering team. This position offers the opportunity to work on exciting projects in an environment with a lot of autonomy where attention to detail, initiative, flexibility, and communication are highly valued. This is an on-site position at a client facility in the Tucson area. This is a salaried 6-month contract with the potential to convert to full-time.

Day-to-Day Responsibilities

• Collaborate with people from 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.

Minimum Qualifications and Experience

• 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 of those years in FDA‑regulated medical devices (21 CFR 820 and ISO 13485 environments).
• Working knowledge of ISO 14971 and design controls.
• You have written protocols and reports that passed review and been part of audits.
• Proven ability to contribute to projects, take initiative, and drive them to successful completion.
• Strong attention to detail and commitment to delivering high‑quality work.
• Clear written communication. You will be writing controlled documents reviewed by technical teams and inspected in audits.

Bonus Points for Any of the Following

• Hands‑on. You can set up a test, run it, and troubleshoot it yourself from first principles.
• IVD or lab‑instrument experience (fluidics, motion, thermal, optics).
• Technical LLM / AI tooling work, using LLMs for design support, scripting, documentation, or test automation.
• IEC 60601-1 or IEC 61010-1 experience.
• Experience running DOE and statistical analysis in Minitab or JMP.
• Requirements tools (Jama, DOORS, Polarion) or PLM/QMS systems (Agile, SAP, Windchill, EtQ).

At Baymar, we passionately deliver precision engineering services and exceptional products for the success of our business partners and the wellbeing of the patients we serve.

Own It: We each have a lot of autonomy, and we own our work from start to finish.

Serve: We keep clients and teammates informed early and plainly, including when something breaks.

Adapt: We approach challenges with an agile and flexible mindset, without ego.

Create Cohesion: We are a small, collaborative team. We protect that vibe!

We encourage you to apply even if your background doesn’t perfectly match this description. Team fit and an eager willingness to learn are really important.

Work Conditions and Expectations

Position Type: Salaried and exempt, 6‑month starting contract with the potential to convert to full-time.

Compensation: $85,000–$100,000 per year.

Benefits: Medical, dental and vision from the first of the month after 30 days; disability and life insurance after 90 days; 2 weeks of PTO a year; 6 paid holidays. If you convert to full‑time, your PTO balance carries over.

Schedule: First shift, coinciding with normal operating hours of Monday to Friday.

Work Environment: As Baymar Solutions operates in a highly regulated environment, employees must complete internal or customer training promptly to continue employment and satisfy FDA guidelines.

Physical Demands: Ability to operate a personal computer and communicate via telephone and/or video meeting technology; give oral presentations. Occasional domestic travel to client or supplier sites may be requested by leadership.

Security & Intellectual Property: Must comply with all company and client security and data protection/usage policies and procedures. Prospective employees are required to sign an Intellectual Property Agreement and Mutual NDA upon offer acceptance.

Background Check: This position will be subject to an electronic background check which can include but not be limited to: National/County Criminal Search, SSN Trace, Global Watchlist and Sex Offender Search. Additional screenings may be necessary based on the role and responsibilities of the position. The client may require its own screening before site access.

Baymar Solutions is an equal opportunity employer. We hire on skills and fit, and we welcome applicants of every background.