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Contract Medical Device Software Engineer Jobs in Arizona

Infostride

Software Engineer

Phoenix, AZ · On-site

Software Engineer - 7 positions Location-Deer Valley AZ (Onsite) Open for fulltime and contract Software Engineer Some items are highlighted in BOLD, which are required for the position and the one ...

Judge Group, Inc.

Software Engineer

Phoenix, AZ · On-site

$53 - $57/hr

Contract (12 Months, with Potential Extension or Conversion) Line of Business: Technology & Operations (TCOO) About the Role We are seeking an experienced Software Engineer - Full Stack .NET ...

Tror AI for everyone

Software Engineer

Chandler, AZ · On-site

Contract Interview Type: Final round will be in person Interview at client location. Detailed JD: * 8+ years of Software Engineering experience, * 5+ years of experience in Application Development ...

Axon

Staff Wireless Software Engineer

Scottsdale, AZ

Experience with 5G sidelink (PC5) or device-to-device protocols * Experience implementing mesh or ... Medical, Dental, Vision plans * Fitness Programs * Emotional & Mental Wellness support * Learning ...

Viasat, Inc.

Embedded Software Engineer

Tempe, AZ · On-site

$174K - $261K/yr

Familiarity with to bare metal embedded device drivers * Microprocessors and embedded processors ... medical, financial, and/or other benefits, dependent on the position offered. Learn more about ...

AVTC Group

Software Engineer C#

Tucson, AZ · On-site

Onsite Tucson, AZ Employment type: Full Time w-2 or Contract. Depending on the type of employment ... Troubleshoot software and test equipment instrumentation Work in a multidiscipline engineering team ...

Axosoft, LLC

Software Engineer

Scottsdale, AZ · On-site

GitKraken Software Engineer: The AI Problem Solver The Company GitKraken is the developer ... Experience designing APIs with clear contracts, validation, error handling, and sensible edge case ...

Connexta

Software Engineer

Phoenix, AZ · On-site

Octo specializes in providing agile software engineering, user experience design, cloud services ... Citizenship (Connexta has some contracts that make this a requirement) Desired Skills and ...

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Contract Medical Device Software Engineer information

What are some common challenges faced by contract medical device software engineers, and how can they be addressed?

Contract Medical Device Software Engineers often encounter the challenge of rapidly adapting to new projects, technologies, and regulatory requirements unique to each client. Working within strict timelines while ensuring compliance with FDA and ISO standards can be demanding. To address these challenges, it's important to have strong communication skills, maintain thorough documentation, and stay updated on industry regulations. Collaborating closely with cross-functional teams—including quality assurance, hardware engineers, and regulatory affairs—also helps ensure project success and smooth integration into existing workflows.

What is the difference between Contract Medical Device Software Engineer vs Medical Device Software Developer?

AspectContract Medical Device Software EngineerMedical Device Software Developer
CredentialsTypically requires a degree in software engineering, biomedical engineering, or related field; certifications like ISO 13485 or FDA compliance knowledge are commonSimilar educational background; often holds certifications in medical device regulations or quality standards
Work EnvironmentContract roles in medical device companies, often project-based, with focus on compliance and validationFull-time or freelance positions within medical device firms, focusing on software development and testing
Industry UsageCommonly hired for specific projects requiring regulatory compliance and validation expertiseInvolved in ongoing software development, maintenance, and updates for medical devices

While both roles require technical expertise in medical device software, Contract Medical Device Software Engineers typically work on short-term projects with a focus on compliance and validation, whereas Medical Device Software Developers are involved in continuous software development and maintenance within the industry.

What is a contract medical device software engineer?

A Contract Medical Device Software Engineer is a software professional who is hired on a temporary or project basis to design, develop, and test software used in medical devices. They typically work with manufacturers to ensure that the software meets regulatory standards, such as those set by the FDA or ISO. Responsibilities may include creating embedded software, documenting code, and collaborating with cross-functional teams to deliver safe and effective medical products. Their expertise is crucial for developing reliable software that supports patient safety and product compliance.

What are the key skills and qualifications needed to thrive as a contract medical device software engineer?

To thrive as a Contract Medical Device Software Engineer, you need a solid background in software development (C/C++/Python), embedded systems, and knowledge of medical device regulations such as IEC 62304, typically supported by a relevant engineering degree. Familiarity with development environments, version control (e.g., Git), and tools for requirements management and verification are essential, along with any certifications in medical device software or quality systems. Strong problem-solving skills, attention to detail, and effective communication are crucial for collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to deliver safe, compliant, and innovative software solutions efficiently in a highly regulated and dynamic industry.
What are the most commonly searched types of Medical Device Software Engineer jobs in Arizona? The most popular types of Medical Device Software Engineer jobs in Arizona are:
What cities in Arizona are hiring for Contract Medical Device Software Engineer jobs? Cities in Arizona with the most Contract Medical Device Software Engineer job openings:
Contract Medical Device Software Engineer jobs near you

X-Ray Engineer (Medical Device)

Ziehm-OrthoScan

Scottsdale, AZ • On-site

Other

Medical, Dental, Vision, Retirement, PTO

Re-posted 3 days ago

Job description

Ziehm Imaging - Orthoscan Inc. is currently seeking a motivated, career-oriented professional with a positive can-do attitude to join our team as a full-time X-Ray Engineer located in Scottsdale, AZ.
Why Work for Ziehm Imaging - Orthoscan Inc.?
There's something special about Ziehm-Orthoscan. There's a sense of pride that comes from building a product that helps improve people's lives and making the most of ourselves as a company and as individuals. We know the success of Ziehm-Orthoscan depends on every employee in our organization; it is our people who make the difference.
What do we offer?
  • The challenge of meaningful work - we offer constant opportunities to grow and develop world-class skills and a truly rewarding career.
  • A unique culture where people convert their passion into action.
  • The kind of competitive compensation you would expect from a world leader.
  • Nine paid holidays plus a generous PTO and vacation time plan.
  • Great benefit plans, major medical, dental and vision.
  • Company 401(k) plan with an employer match.
  • Competitive salary commensurate with experience

JOB SUMMARY:
Lead all engineering and production aspects of X-Ray Generation, including electrical high voltage design, glassware, heat management, and lean and quality production processes. Working closely with R&D, QARA, and Production, the X-Ray Engineer serves as the critical technical bridge between engineering design and manufacturing operations, architecting, designing, and developing next-generation X-ray generator assemblies, high-voltage subsystems, high-voltage insulation systems, and oil-filled assemblies from initial engineering concepts through final mass production. Leveraging a strong background in high-voltage testing methodologies and robust manufacturing processes, this role translates research and development concepts into scalable, manufacturable, high-power hardware by applying advanced root-cause analysis and problem-solving techniques. The position also utilizes excellent written and verbal communication skills to develop automated test procedures, manufacturing process documentation, work instructions, validation protocols, and factory acceptance criteria that ensure product quality, clinical reliability, manufacturing efficiency, and strict regulatory compliance
ESSENTIAL FUNCTIONS:
  • Own the electrical engineering design, conceptualization, and manufacturing transfer of X-ray generator assemblies, High-Voltage subsystems, High-Voltage insulation systems, and oil-filled assemblies, ensuring sound manufacturing methodologies are engineered directly into the initial layout. Develop technical solutions to achieve marketing/sales requirements to ISO13485 standards
  • Develop, maintain, and improve manufacturing processes, fixtures, work instructions, and acceptance criteria while designing and refining the underlying product architectures
  • Drive reliability improvements for X-ray generator assemblies, High-Voltage subsystems, insulation systems, and oil-filled assemblies by developing, implementing, and executing advanced, physical High-Voltage testing methodologies and validation protocols, ensuring all products are built, tested, and validated to IEC60601-1 4th edition standards
  • Lead data-driven failure analysis, root-cause investigations, corrective actions, and field-return evaluations to implement Engineering Change Orders (ECOs) that directly improve product performance and production yield.
  • Troubleshoot manufacturing, assembly, test, and performance issues related to High-Voltage and X-ray systems, verbally collaborating across R&D, QARA, and Production to deploy rapid, permanent technical solutions.
  • Identify and implement continuous improvement opportunities across processes, work instructions, product quality, and manufacturing efficiency to maintain statistical control of the production line.
  • Own the entire generator technical lifecycle-from incoming parts and assembly processes through burn-in, clinical reliability, and field-return investigations.

Basic Qualifications:
Education:
  • Bachelor's degree in Electrical Engineering (BSEE) or a closely related engineering discipline with a strong academic focus in Power Electronics, Electromagnetic Field Theory, or High-Voltage Physics. An advanced Master's degree in Manufacturing Engineering or related disciplines is a plus.
  • 3+ years of progressive electrical or hardware engineering experience designing, developing, validating, and implementing complex high-power or high-voltage (kV-level) electrical systems, with demonstrated expertise in product development and production readiness.
  • 2+ years of progressive electrical engineering experience with demonstrated manufacturing engineering expertise, including manufacturing process development and new product introduction (NPI), is required, preferably in a medical device industry environment.

Experience
  • High-Voltage testing & process transition experience in engineering or production test engineering (preferably in the medical/industrial X-ray industry), with a proven track record of implementing sound manufacturing processes and safely configuring high-power test benches operating between 40kV and 150kV
  • Structured failure investigation experience leading structured root-cause analysis and problem-solving techniques to dissect generator breakdowns, electrical arcs, and contamination events from factory burn-in failures through clinical field returns.
  • Cross-Functional technical communication: Demonstrated history of utilizing excellent written and verbal communication skills to bridge the gap between R&D, QARA, and Production-specifically transforming complex engineering requirements into audit-ready documentation and manufacturing work instructions.

Competencies:
  • Mastery of specialized high-voltage test equipment, including digital oscilloscopes, high-voltage probes, insulation resistance testers, power analyzers, and partial discharge measurement systems
  • Comprehensive knowledge of high-voltage insulation systems, creepage and clearance design, dielectric breakdown, oil insulation systems, electric field management, and vacuum/altitude effects
  • Deep understanding of tube current regulation, filament and anode operation, dark current, tube aging, and tube vacuum behavior.
  • Strong understanding of switching power supplies, resonant converters, inverters, PWM systems, feedback loops, and high-voltage multipliers.
  • Advanced proficiency in evaluating manufacturing processes to maintain strict control, determine process capabilities, design assembly fixtures, and establish compliant process validation (IQ/OQ/PQ) and acceptance criteria
  • Solid understanding of cleanliness and contamination control during assembly, with specific expertise regarding fluid contamination in oil-filled assemblies
  • Application of structured reliability principles and problem-solving techniques to identify root-cause failures, evaluate field returns, and directly improve production yields.
  • Experience in verifying products that meet regulatory/safety standards, using outside test agencies.
  • Keep abreast of new products, trends, and practices within the field/scope of practice as needed

Working Conditions:
  • Majority of the work is performed in a manufacturing and office environment.
  • Typical working hours and days are Monday - Friday 7am - 4pm, however this is subject to change depending on work demands
  • Periodic travel may be required (visit vendors, customers, training activities, etc.).
  • May require PPE and periodic exposure to low dose radiation.


We support a drug free work environment
EOE/M/F/Disability/Vet All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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