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Quality Engineer Medical Devices Jobs in Colorado

... reliable medical devices, this role offers an opportunity to make meaningful impact while ... Provide quality engineering support for sustaining engineering initiatives across technical ...

... reliable medical devices, this role offers an opportunity to make meaningful impact while ... Provide quality engineering support for sustaining engineering initiatives across technical ...

... reliable medical devices, this role offers an opportunity to make meaningful impact while ... Provide quality engineering support for sustaining engineering initiatives across technical ...

Job TitleSupplier Quality Engineer The Supplier Quality Engineer supports supplier qualification ... Canadian Medical Devices Regulation (SOR/98-282). * You have proven experience utilizing data ...

Supplier Quality Engineer

Colorado Springs, CO ยท On-site

$63K - $100K/yr

Job Title Supplier Quality Engineer The Supplier Quality Engineer supports supplier qualification ... Canadian Medical Devices Regulation (SOR/98-282). * You have proven experience utilizing data ...

Senior Quality Engineer

Englewood, CO ยท On-site

$95K - $121K/yr

The Senior Quality Engineer plays a critical role in ensuring that products and processes meet the ... Experience working in regulated industries such as pharmaceuticals, medical devices, or aerospace.

Sr. Mechanical Engineer -

Lafayette, CO ยท Hybrid

$108K - $143K/yr

Senior Mechanical Engineer (Medical Devices - Design & Sustaining Engineering) Location: [Lafayette ... This role will be responsible for delivering robust, compliant, and high-quality mechanical designs ...

Sr. Mechanical Engineer -

Lafayette, CO ยท Hybrid

$108K - $143K/yr

Senior Mechanical Engineer (Medical Devices - Design & Sustaining Engineering) Location: [Lafayette ... This role will be responsible for delivering robust, compliant, and high-quality mechanical designs ...

Sr. Mechanical Engineer -

Lafayette, CO ยท On-site

$108K - $143K/yr

Senior Mechanical Engineer (Medical Devices - Design & Sustaining Engineering) Location: [Lafayette ... This role will be responsible for delivering robust, compliant, and high-quality mechanical designs ...

Quality Engineer

Lakewood, CO ยท On-site

$71K - $92K/yr

The Quality Engineer will provide technical quality leadership across the value stream, raw ... We offer comprehensive benefits including PTO, paid holidays, medical, dental and vision insurance ...

Quality Engineer

Denver, CO

$71K - $92K/yr

The Quality Engineer will provide technical quality leadership across the value stream, raw ... We offer comprehensive benefits including PTO, paid holidays, medical, dental and vision insurance ...

Quality Engineer

Lakewood, CO ยท On-site

$71K - $92K/yr

The Quality Engineer will provide technical quality leadership across the value stream, raw ... We offer comprehensive benefits including PTO, paid holidays, medical, dental and vision insurance ...

Quality Engineer

Lakewood, CO ยท On-site

$80K - $90K/yr

The Quality Engineer will provide technical quality leadership across the value stream, raw ... We offer comprehensive benefits including PTO, paid holidays, medical, dental and vision insurance ...

Quality Engineer

Boulder, CO ยท On-site

$116K - $192K/yr

Quality Engineer BELONG. CONNECT. GROW. with KBR. Around here, we define the future. We are a ... with company match, medical, dental, vision, life insurance, AD&D, flexible spending account ...

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Showing results 1-20

Quality Engineer Medical Devices information

See Colorado salary details

$47.3K

$88.4K

$125.1K

How much do quality engineer medical devices jobs pay per year?

As of Aug 15, 2026, the average yearly pay for quality engineer medical devices in Colorado is $88,369.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,700.00 and $97,800.00 per year, depending on experience, location, and employer.

What does a quality engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that products meet regulatory standards and quality requirements throughout their lifecycle. They develop and implement quality control processes, conduct risk assessments, lead investigations into product defects, and work closely with cross-functional teams to ensure compliance with regulations such as FDA and ISO 13485. Their work helps to guarantee the safety, reliability, and effectiveness of medical devices before they reach patients.

How does a quality engineer collaborate with cross-functional teams in the medical device industry?

Quality Engineers in the medical device field work closely with design, manufacturing, and regulatory teams to ensure products meet stringent quality and compliance standards. They participate in design reviews, help develop verification and validation protocols, and support the implementation of corrective actions. Regular communication with production and R&D teams is essential to identify potential risks early and to ensure that quality is built into every stage of product development. This collaborative approach not only improves product safety and efficacy but also streamlines regulatory submissions and audits.

What is the difference between Quality Engineer Medical Devices vs Quality Technician Medical Devices?

AspectQuality Engineer Medical DevicesQuality Technician Medical Devices
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, basic quality certifications
ResponsibilitiesDesigning quality systems, process improvements, root cause analysisInspecting products, conducting tests, recording quality data
Work EnvironmentDesign and development labs, manufacturing plantsManufacturing floors, quality control labs
Employer & Industry UsageMedical device companies, OEMs, suppliersManufacturers, contract labs, quality departments

In summary, Quality Engineer Medical Devices focus on developing quality systems, process improvements, and ensuring compliance, while Quality Technicians primarily perform product inspections and testing. Both roles are essential in maintaining high standards in the medical device industry but differ in scope and responsibilities.

What are the key skills and qualifications needed to thrive as a quality engineer in medical devices, and why are they important?

To thrive as a Quality Engineer in Medical Devices, you typically need a degree in engineering or a related field, combined with knowledge of quality assurance principles and regulatory requirements (such as ISO 13485 and FDA regulations). Familiarity with risk management tools, validation protocols, and quality management systems (QMS), as well as certifications like CQE (Certified Quality Engineer), are highly valuable. Strong analytical thinking, attention to detail, and effective communication skills enable you to identify issues, collaborate with cross-functional teams, and ensure compliance. These competencies are crucial for maintaining product safety, meeting regulatory standards, and supporting a culture of continuous improvement in the medical device industry.

What are popular job titles related to Quality Engineer Medical Devices jobs in Colorado?

For Quality Engineer Medical Devices jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Quality Engineer Medical Devices jobs in Colorado look for?

The top searched job categories for Quality Engineer Medical Devices jobs in Colorado are:

What cities in Colorado are hiring for Quality Engineer Medical Devices jobs?

Cities in Colorado with the most Quality Engineer Medical Devices job openings:

Infographic showing various Quality Engineer Medical Devices job openings in Colorado as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, and 5% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $88,369 per year, or $42.5 per hour.

Firmware Engineer - Medical Devices

Terumo BCT, Inc.

Lakewood, CO โ€ข On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 10 days ago


Job description

Requisition ID: 35242
At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.
We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient's life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.
With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.
The firmware this engineer writes runs inside medical devices used to care for patients around the world, so it has to work correctly and safely. This is hands-on work close to the silicon: bringing up new boards, writing the low-level drivers, and building the real-time control systems that make the hardware do its job. The engineer carries firmware from the first board bring-up through to a maintainable, production-ready product.
The role spans the firmware stack: embedded Linux on NXP i.MX processors and low-level firmware on the NXP ARM Cortex-M4 microcontrollers used in current TBCT designs. The Firmware Engineer delivers firmware for products in the field today and helps advance future platform generations built around more capable processors and emerging on-chip technologies. The firmware produced in this role directly shapes device reliability, performance, and compliance with medical device quality and regulatory standards.
Collaboration is central to the role. The Firmware Engineer works closely with Electrical Engineering, Systems Engineering, Software, DevOps, and Quality to bring up new hardware, integrate firmware into the larger system, and turn product requirements into testable, verifiable firmware that performs dependably in the field.
ESSENTIAL DUTIES
  • Own board bring-up on new and revised hardware, verifying power sequencing, clocks, memory, and peripherals on the first boards and working with Electrical Engineering to contribute to architecture/schematic reviews, board bring-up, and resolving hardware and firmware issues.
  • Write, port, and debug device drivers and low-level interfaces (I2C, SPI, UART, USB, GPIO, ADC/DAC, PWM, DMA) for on-board sensors, actuators, and communication peripherals.
  • Develop firmware for the control systems that operate physical hardware such as motors, valves, pumps, and heaters, including real-time, timing-sensitive control loops.
  • Develop and maintain the embedded Linux stack on NXP i.MX platforms, including board support packages, device trees, kernel configuration, operating system integration, and userspace services, within a Yocto build environment.
  • Help evaluate and choose microcontroller architectures for future platforms, including parts with advanced on-chip processing capabilities, by building prototypes, benchmarking performance and power, and writing up the trade-offs.
  • Optimize firmware for speed, memory footprint, and power on resource-constrained targets.
  • Develop and maintain bootloaders, secure boot, and firmware update paths so devices start reliably and stay current in the field.
  • Translate system and product requirements into firmware designs, and produce the design documentation required by regulatory and quality processes (IEC 62304, ISO 14971, ISO 13485).
  • Plan and execute firmware verification and validation, and resolve issues found in development, integration, and the field. Create and execute automated unit tests, integration tests, and hardware-in-the-loop (HIL) testing.
  • Participate in and lead code and design reviews, and mentor engineers earlier in their careers.
  • Participate in software risk assessments, hazard analyses, SWFMEA and implement cybersecurity principles for connected devices
  • Partner with Systems, Electrical, Mechanical, and Quality Engineering across the full product lifecycle, from first prototype through production.

OTHER DUTIES AND RESPONSIBILITIES
  • Help improve firmware development and test processes so they meet industry standards and internal benchmarks, and support inspection readiness with clear documentation and traceability.
  • Keep firmware maintainable, reusable, and scalable so it integrates cleanly across projects and platforms.
  • Stay current with embedded tools, techniques, and security practices, and bring useful improvements back to the team.

MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor's degree in Computer Engineering, Electrical Engineering, Computer Science, or a related field, or an equivalent combination of education and experience sufficient to successfully perform the essential functions of the job.
Experience
Minimum 4 years of experience developing embedded firmware for hardware products, including hands-on board bring-up and hardware debugging carried through to a shipped product. Experience in a regulated industry (medical, automotive, or aerospace) is preferred.
Skills
  • Strong proficiency in C/C++ on resource-constrained embedded targets.
  • Hands-on microcontroller and SoC development on ARM-based architectures, such as NXP i.MX processors and ARM Cortex-M4 microcontrollers.
  • Board bring-up and hardware debugging with oscilloscopes, logic analyzers, and JTAG/SWD debuggers.
  • Solid command of low-level I/O and serial protocols (I2C, SPI, UART, USB, GPIO).
  • Working knowledge of embedded Linux internals, including the kernel, device drivers, device trees, and board support packages, and/or real-time and bare-metal firmware.
  • Experience with a Yocto build environment; Buildroot or PetaLinux also applicable.
  • Ability to read schematics and datasheets and determine whether an issue is rooted in hardware, firmware, or software.
  • Proficient in source code management and CI workflows (e.g., Git and GitLab), with scripting in Python or Bash.
  • Familiarity with wired and wireless connectivity, including TCP/IP, Wi-Fi, Bluetooth/BLE, and 5G.
  • Familiarity with medical device standards and lifecycle processes (IEC 62304, ISO 14971, ISO 13485, IEC 60601) is preferred.
  • Experience or demonstrated ability to work in middleware and user-space components, including interprocess communication, service design, and system-level integration on embedded Linux is preferred.
  • Clear communication and disciplined documentation habits, which matter in a regulated environment.

-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
LOCATION
Hybrid position reporting to the Lakewood, CO headquarters a minimum of 3 days a week.
PHYSICAL REQUIREMENTS
  • Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
  • The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range: $109,800.00 to $137,200.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base: 7.0%
We anticipate this requisition will be open for a minimum of five days, from August 5, 2026. We encourage your prompt application.
At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
  • We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect - Appreciative of others
    • Integrity - Guided by our mission
    • Care - Empathetic to patients
    • Quality - Committed to excellence
    • Creativity - Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.