ZipRecruiter

Log In

1

Director Biomedical Engineering Jobs in Oregon (NOW HIRING)

Grant Engine

Required Qualifications: · PhD in biological sciences, biomedical engineering, or other life ... Defense's Congressionally Directed Medical Research Programs is a plus. · Knowledge of ...

Pwc

Supply Chain Execution Senior Associate

Portland, OR · On-site

$77K - $202K/yr

Aerospace Engineering, Automotive Engineering, Biomedical Engineering, Chemical Engineering ... At PwC, we recognize that conviction records may have a direct, adverse, and negative relationship ...

Abbott

Engineering Manager

Portland, OR · On-site

$113K - $226K/yr

Provide technical oversight and leadership to direct reports regarding project prioritization, new ... Bachelor's Degree in Engineering (preferably Biomedical, Mechanical, Electrical, or Manufacturing)

Abbott

Engineering Manager

Portland, OR

$113K - $226K/yr

Provide technical oversight and leadership to direct reports regarding project prioritization, new ... Bachelor's Degree in Engineering (preferably Biomedical, Mechanical, Electrical, or Manufacturing)

Abbott

Engineering Manager

Portland, OR · On-site

$113K - $226K/yr

Provide technical oversight and leadership to direct reports regarding project prioritization, new ... Bachelor's Degree in Engineering (preferably Biomedical, Mechanical, Electrical, or Manufacturing)

next page

Showing results 1-20

All JobsBiomedical Engineering JobsDirector Biomedical Engineering JobsDirector Biomedical Engineering Jobs in Oregon

Director Biomedical Engineering information

What is a director biomedical engineering?

A Director of Biomedical Engineering oversees the development, implementation, and maintenance of medical equipment and technologies in healthcare settings. They manage teams of engineers and technicians, ensure compliance with regulations, and work to improve patient care through innovative solutions. This role requires expertise in biomedical engineering, leadership skills, and experience in healthcare technology management.

What are the key skills and qualifications needed to thrive as a director biomedical engineering?

To thrive as a Director Biomedical Engineering, a deep knowledge of biomedical engineering principles, project management, and regulatory compliance is essential, typically supported by an advanced degree in engineering or related fields. Familiarity with hospital systems, medical device software, risk management protocols, and certifications such as CBET or CCE are commonly expected. Strong leadership, strategic planning, and effective communication skills help manage diverse teams and collaborate with clinicians and administrators. Together, these competencies ensure optimal technology integration, patient safety, and the successful operation of biomedical programs in healthcare environments.

What are some of the main challenges faced by a director biomedical engineering in a hospital or clinical setting?

One of the primary challenges for a Director of Biomedical Engineering is ensuring that all medical equipment is both technologically up-to-date and compliant with safety regulations, while balancing budget constraints. Directors must coordinate with multiple departments, facilitate staff training, and manage vendor relationships, often under time pressure when equipment issues arise. Additionally, staying ahead of rapid technological advancements and integrating new devices into existing systems can be demanding. However, overcoming these challenges makes the role both dynamic and rewarding, as it directly impacts patient care quality and operational efficiency.

What are the most commonly searched types of Biomedical Engineering jobs in Oregon?

The most popular types of Biomedical Engineering jobs in Oregon are:

What are popular job titles related to Director Biomedical Engineering jobs in Oregon?

For Director Biomedical Engineering jobs in Oregon, the most frequently searched job titles are:

What job categories do people searching Director Biomedical Engineering jobs in Oregon look for?

The top searched job categories for Director Biomedical Engineering jobs in Oregon are:

What cities in Oregon are hiring for Director Biomedical Engineering jobs?

Cities in Oregon with the most Director Biomedical Engineering job openings:

Director Biomedical Engineering jobs near you

Associate Director, Device Engineering

OR • On-site, Remote

Kailera Therapeutics, Inc.
See more jobs at Kailera Therapeutics, Inc.external

Full-time

Posted 5 days ago

Job description

What You'll Do:

We are seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens. This role will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development aligned with meeting patient needs, global standards, and regulatory expectations.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).

Responsibilities:

  • Lead combination product development projects (prefilled syringes, autoinjectors, and/or multidose pens) from concept through commercialization
  • Build and execute project plans with clearly defined risks and milestones
  • Develop device and combination product requirements, including user and stakeholder needs and technical requirements, and ensure appropriate engineering translation and subsequent verification and validation of requirements
  • Oversee and ensure compliance with design controls per FDA and ISO 13485 requirements
  • Manage risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and risk mitigation strategies
  • Drive design verification and validation activities, including test method development, protocol execution, and documentation
  • Oversee human factors and usability engineering efforts, ensuring compliance with FDA guidance and IEC 62366
  • Facilitate design transfer to manufacturing, ensuring smooth transition and scalability
  • Partner cross-functionally with CMC, quality, regulatory, clinical development, commercial/marketing, supply chain, and other key functions to ensure critical inputs are integrated into device development activities
  • Author relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for devices and combination product programs
  • Manage and collaborate with vendors, including Contract Design and Manufacturing Organizations (CDMOs) and suppliers, to ensure components and products meet quality and technical requirements and to integrate deliverables into the project Design History File at various stages of development and manufacturing
  • Manage and collaborate with contract test labs to ensure testing strategy, method validation, and test execution are aligned with relevant standards and quality and technical requirements and integrate testing results into the Design History File
  • Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, IEC 62366

Required Qualifications:

  • Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role
  • Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions
  • Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer
  • Strong knowledge of applicable regulatory standards and guidance documents
  • Excellent communication, leadership, and cross-functional collaboration skills

 

Preferred Qualifications:

  • Experience working in a regulated pharmaceutical or biotech environment
  • Familiarity with combination product regulations (21 CFR Part 4)
  • Experience with supplier management of external development, testing, and manufacturing partners
  • PMP certification or formal project management training is a plus

Education:

  • Bachelor's degree in mechanical engineering, Biomedical Engineering, or related field. Advanced degree preferred.

Apply