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Medical Device Risk Management Jobs in Portland, OR

A-dec, Inc.

Manager, Quality Assurance

Newberg, OR · On-site

... 282, Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745) and quality ... management skills; exercise good judgement using risk-based decision making, and use resources ...

A-dec, Inc.

Manager, Quality Assurance

Newberg, OR · On-site

... 282, Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745) and quality ... management skills; exercise good judgement using risk-based decision making, and use resources ...

Legacy Health

Cardiac Device Technician

Portland, OR · On-site

$32.96 - $47.12/hr

Manages device patients and their care implementing treatment plans in collaboration with ... Develops strong and credible relationships with medical and non-medical staff and peers. Ability to ...

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Portland, OR

Medical Device Risk Management information

See Portland, OR salary details

$54.6K

$118.3K

$180.3K

How much do medical device risk management jobs pay per year?

As of Sep 10, 2026, the average yearly pay for medical device risk management in Portland, OR is $118,306.00, according to ZipRecruiter salary data. Most workers in this role earn between $95,400.00 and $136,800.00 per year, depending on experience, location, and employer.

What is medical device risk management?

Medical device risk management is the systematic process of identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This process ensures that potential hazards are minimized to protect patient safety and comply with regulatory standards, such as ISO 14971. Risk management includes activities like risk assessment, implementing controls, monitoring, and documenting all steps to demonstrate compliance. It is a critical function in the design, manufacturing, and post-market phases of medical device development.

How does a medical device risk management professional typically collaborate with cross-functional teams during the product development lifecycle?

Medical Device Risk Management professionals work closely with engineering, regulatory affairs, quality assurance, and clinical teams to identify, assess, and mitigate potential risks associated with medical devices. They participate in design reviews, facilitate risk assessments such as FMEA, and ensure that risk controls are effectively implemented and documented according to regulatory standards like ISO 14971. Regular communication and collaboration are essential to align risk management activities with project timelines and compliance requirements, ensuring patient safety and product success.

What are the key skills and qualifications needed to thrive in medical device risk management, and why are they important?

To thrive in Medical Device Risk Management, you need a solid background in engineering or life sciences, a thorough understanding of regulatory standards (such as ISO 14971), and experience in risk assessment processes. Familiarity with risk management software, quality management systems, and relevant regulatory databases is typically required, along with certifications like Certified Risk Manager (CRM) or RAC. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for evaluating risks and collaborating with cross-functional teams. These competencies ensure the safety and compliance of medical devices, protecting both end-users and the company from regulatory or safety issues.

What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?

AspectMedical Device Risk ManagementMedical Device Quality Assurance
Primary FocusIdentifying, evaluating, and mitigating risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, RAPS certifications often preferredISO 13485, regulatory compliance certifications
Work EnvironmentDesign and development teams, risk analysis meetingsManufacturing, inspection, and quality control departments
Industry UsageUsed throughout product lifecycle for safety managementUsed to maintain product quality and compliance

While both roles are essential in the medical device industry, Risk Management focuses on minimizing safety risks throughout the product lifecycle, whereas Quality Assurance ensures products consistently meet quality and regulatory standards. Understanding these differences helps professionals align their skills with industry needs.

What job categories do people searching Medical Device Risk Management jobs in Portland, OR look for?

The top searched job categories for Medical Device Risk Management jobs in Portland, OR are:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in Portland, OR as of June 2026, with employment types broken down into 1% As Needed, 89% Full Time, 1% Part Time, 1% Temporary, and 8% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $118,306 per year, or $56.9 per hour.

Project Manager, Microelectronics Engineering

Lake Oswego, OR • On-site

Biotronik
See more jobs at Biotronikexternal

Full-time

Re-posted 13 days ago

Job description

Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company's core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.
Please join us as:
Project Manager, Microelectronics Engineering
We are hiring a Project Manager to join our elite Microelectronics group at our U.S. headquarters. In this role, you will lead complex, high-impact programs focused on developing implantable microelectronic devices and the advanced manufacturing processes behind them. You will guide cross-functional teams, drive technical execution, and ensure seamless coordination across customers, internal partners, and key stakeholders. You will leverage your electronics engineering background and proven project management experience to deliver innovative, high-profile medical device programs that that make a meaningful impact for our customers and the patients they serve.
YOUR RESPONSIBILITIES
Customer Contact
  • New Business Development
  • New Product Introduction
  • Product Life Cycle Management

Project Management
  • Lead cross-functional engineering teams to deliver complex projects.
  • Translate customer requirements into clear technical specifications and deliverables.
  • Manage end-to-end project planning, including budgets, schedules, and risk mitigation.

Technical Leader
  • Drive projects from concept through launch into serial production.
  • Leverage MSEI's engineering capabilities to deliver innovative, automation-ready product designs for serial manufacturing.

REQUIRED QUALIFICATIONS
  • Bachelor's degree in Electrical Engineering, Mechanical Engineering, Engineering & Technology Management, or a related field.
  • 5+ years leading cross-functional technical projects with multiple stakeholders.
  • Proven experience in electronics development or related engineering environments.
  • Strong leadership and problem-solving skills.
  • Excellent customer relationship and stakeholder management abilities.
  • Effective communication and interpersonal skills (written and verbal).
  • Self-starter with strong initiative and ability to learn quickly.

PREFERRED QUALIFICATIONS
  • 5+ years of technical project management experience in microelectronics, advanced packaging, semiconductors, or related disciplines.
  • Experience developing medical devices or other high-reliability electronics, including PCBA, electronic assembly/IC packaging, and component-level technologies.
  • Proven ability to plan, execute, and deliver microelectronics prototyping and technology-transition projects from concept to production readiness.
  • Strong knowledge of SPC, DOE, and DFM for optimizing yield, performance, and process robustness.
  • Proficient with Microsoft Office, Teams, MS Project, and SAP for procurement, materials coordination, and build scheduling.

PHYSICAL REQUIREMENTS
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to be independently mobile.
  • The employee is also required to interact with a computer for extended periods of time and communicate with co-workers.
  • Must be able to travel to other office locations.

TRAVEL REQUIREMENTS
Must be able to travel internationally and domestically, less than 5% of the time.
Location: Lake Oswego(0001)
Working hours: Full-time
MSEI Lake Oswego Oregon (US-OR) USA
Job ID: 62388
Micro Systems Engineering, Inc. (MSEI) is committed to equal employment opportunity. We consider all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by law.

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