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Medical Device Operations Jobs in Arizona (NOW HIRING)

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... operations of the Human Resources function. The HR Generalist will serve as a key resource for ... Experience in healthcare, medical device, manufacturing, technical services, or a related industry ...

Expert knowledge of MEDDEV 2.7/1 Rev. 4, European Union Medical Device Regulation (EU MDR 2017/745 ... Knowledge of clinical operations, risk management, and international regulatory requirements.

... Medical Device Manufacturing performance. The position is on the Site Leadership Team and advises the Manufacturing Site Director and extended Operations leadership team on strategy and business ...

... Medical Device Manufacturing performance. The position is on the Site Leadership Team and advises the Manufacturing Site Director and extended Operations leadership team on strategy and business ...

... Medical Device Manufacturing performance. The position is on the Site Leadership Team and advises the Manufacturing Site Director and extended Operations leadership team on strategy and business ...

Senior Operations Manager

Phoenix, AZ · On-site

$136 - $226/hr

Join Stryker in a leadership role overseeing manufacturing operations within a regulated medical device environment. This position is responsible for leading manufacturing, planning, purchasing ...

This role is integral to Banner Health's medical device security program, ensuring compliance and ... Operations (experience with information technology related to workstations, networking, and ...

This role is integral to Banner Health's medical device security program, ensuring compliance and ... Operations (experience with information technology related to workstations, networking, and ...

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Medical Device Operations information

What is medical device operations?

Medical device operations refer to the processes and activities involved in the manufacturing, assembly, quality control, supply chain management, and distribution of medical devices. This field ensures that devices are produced efficiently, meet regulatory standards, and are delivered safely to healthcare providers and patients. Operations teams collaborate with engineering, quality assurance, and regulatory departments to maintain compliance and optimize production workflows. Their work is crucial for ensuring that medical devices are safe, effective, and readily available for patient care.

What are the key skills and qualifications needed to thrive in medical device operations?

To thrive in Medical Device Operations, you need a solid understanding of regulatory compliance, quality assurance, and supply chain management, often supported by a degree in engineering, life sciences, or business. Familiarity with quality management systems (QMS), FDA regulations, and software like ERP systems is typically required. Strong organizational skills, attention to detail, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring compliance. These competencies are vital for delivering safe, high-quality medical devices efficiently and in accordance with rigorous industry standards.

What are some common challenges faced by professionals in medical device operations, and how can they be addressed?

Professionals in Medical Device Operations often face challenges related to maintaining strict regulatory compliance, ensuring product quality, and managing cross-functional communication between manufacturing, quality assurance, and regulatory teams. Staying up to date with changing FDA or international regulations is essential, and frequent documentation or process audits can be demanding. Building strong organizational habits, leveraging digital tracking tools, and fostering open communication channels with other departments can help address these challenges and ensure smooth operations.

What is the difference between Medical Device Operations vs Medical Device Quality Assurance?

AspectMedical Device OperationsMedical Device Quality Assurance
Primary FocusManaging manufacturing, supply chain, and product deploymentEnsuring product quality, compliance, and safety standards
Required CertificationsRegulatory knowledge, manufacturing certificationsQuality management certifications, ISO standards
Work EnvironmentManufacturing plants, supply chain settingsQuality labs, compliance departments
Industry UsageUsed across production and logistics teamsUsed within quality control and regulatory teams

Medical Device Operations and Medical Device Quality Assurance roles often overlap but focus on different aspects of the product lifecycle. Operations centers on manufacturing and logistics, while Quality Assurance emphasizes compliance and safety. Both roles require regulatory knowledge and are essential in the medical device industry.

What are popular job titles related to Medical Device Operations jobs in Arizona?

For Medical Device Operations jobs in Arizona, the most frequently searched job titles are:

What job categories do people searching Medical Device Operations jobs in Arizona look for?

The top searched job categories for Medical Device Operations jobs in Arizona are:

What cities in Arizona are hiring for Medical Device Operations jobs?

Cities in Arizona with the most Medical Device Operations job openings:

Infographic showing various Medical Device Operations job openings in Arizona as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, and 5% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution.

Director Medical Device Manufacturing Operations

Castle Biosciences, Inc

Phoenix, AZ • On-site

Full-time

Medical, Retirement, PTO

Posted 8 days ago


Job description

Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood!

Learn more at www.CastleBiosciences.com

Castle Biosciences Inc. is growing, and we are looking to hire a full-time Director Medical Device Manufacturing Operations working from our Phoenix, AZ office location, with a start date on or before October 1, 2026.

Why Castle Biosciences?

Exceptional Benefits Package:

  • Excellent Annual Salary + 35% Bonus Potential
  • 20 Accrued PTO Days Annually + 10 Paid Holidays
  • 401K with 100% Company Match up to 6%
  • 3 Health Care Plan Options + Company HSA Contribution
  • Company Stock Grant Upon Hire

A DAY IN THE LIFE OF the Director Medical Device Manufacturing Operations

We're building a brand-new medical device manufacturing operation and need an experienced leader to build it from the ground up. This Director-level role will own everything from facility startup and process validation, to team building and day-to-day operations. All within an FDA-regulated environment. It's a high-visibility opportunity for someone who thrives on creating something from scratch and wants to make a real impact at a growing diagnostics company. What you'll do: Lead the startup and commercial launch of Castle's new manufacturing facility; from equipment installation and process validation through first production runs; build and lead the manufacturing team, including hiring managers, supervisors, and technicians, and establishing the training and operational systems they need to succeed; own day-to-day manufacturing performance including safety, quality, delivery, and cost; while driving continuous improvement and ensuring ongoing FDA/ISO compliance.

REQUIREMENTS

  • Bachelor's degree in Engineering, Life Sciences, Operations Management, or related field; advanced degree (MBA, MS Engineering, or related) preferred
  • 10+ years of progressive manufacturing leadership experience in medical device, diagnostics, or biotechnology industries, with at least 5 years in director-level or equivalent roles
  • Proven experience leading manufacturing startup operations, greenfield site launches, or significant facility expansions in FDA-regulated environments (21 CFR 820, ISO 13485, GMP)
  • Strong understanding of process validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation systems

*Please see the full job description at the end of the job ad.

SCHEDULE

  • This is a full-time onsite role in Phoenix, Monday-Friday, with hours that vary based on operational needs, especially during the startup phase.

READY TO JOIN OUR BIOTECH TEAM?

We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon!

Castle Biosciences Awards and Research Developments!

WORK AUTHORIZATION

All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.

ABOUT CASTLE BIOSCIENCES INC.

At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes.

Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development.

Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ReasonableAccommodationsRequest@castlebiosciences.com.

This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

** No third-party recruiters, please