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Biomedical Operations Manager Jobs in Delaware (NOW HIRING)

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

Familiarity with root cause analysis tools, risk management principles, and compliance frameworks ... Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering ...

Roquette

Associate Scientist

Wilmington, DE · On-site

$86K - $95K/yr

Operation of analytical and characterization equipment (e.g., cell counting, metabolite analysis ... Bachelor's Degree in Chemistry, Biology, Biochemistry, Chemical/Bioengineering, Biomedical ...

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Biomedical Operations Manager information

What is a biomedical operations manager?

Biomedical Operations Managers are professionals responsible for overseeing the daily operations of biomedical departments in healthcare facilities or research institutions. They coordinate the maintenance and repair of medical equipment, ensure compliance with regulations, manage budgets, and supervise technical staff. Their role is crucial in ensuring that medical devices and equipment are safe, functional, and available when needed, which directly impacts patient care and research outcomes.

What are the key skills and qualifications needed to thrive as a biomedical operations manager?

To thrive as a Biomedical Operations Manager, you need expertise in biomedical engineering principles, operational management, regulatory compliance, and typically a relevant bachelor’s or master’s degree. Familiarity with medical equipment management systems, quality assurance tools, and certifications such as CBET (Certified Biomedical Equipment Technician) are highly valuable. Strong leadership, problem-solving abilities, and excellent communication skills help manage teams and liaise effectively with clinical staff. These skills are crucial for ensuring safe, efficient, and compliant operation of biomedical equipment in healthcare environments.

What are some common challenges a biomedical operations manager faces in managing cross-functional teams?

Biomedical Operations Managers often work with multidisciplinary teams including researchers, engineers, clinicians, and regulatory staff. A key challenge is ensuring clear communication and alignment of project goals across these diverse groups. Additionally, balancing compliance with strict regulatory standards while maintaining efficient workflows can be demanding. Successful managers foster collaboration, implement robust processes, and proactively address potential bottlenecks to keep projects on track.

What is the difference between Biomedical Operations Manager vs Biomedical Technician?

AspectBiomedical Operations ManagerBiomedical Technician
CredentialsTypically requires a bachelor's degree in biomedical engineering or related field; certifications like CBET are commonUsually requires an associate degree or certification in biomedical technology or related field
Work EnvironmentOversees departments, manages teams, and coordinates maintenance and compliance in healthcare facilitiesPerforms equipment repairs, maintenance, and calibration directly on medical devices
Employer & Industry UsageUsed in hospitals, clinics, and biomedical companies for management rolesFound in hospitals, clinics, and biomedical service companies for technical roles

The Biomedical Operations Manager focuses on overseeing biomedical departments, managing staff, and ensuring compliance, while the Biomedical Technician handles hands-on maintenance and repair of medical equipment. Both roles are essential in healthcare settings but differ in responsibilities and required qualifications.

How much do biomedical operations managers make in the US?

Biomedical operations managers in the US typically earn between $80,000 and $130,000 annually, depending on experience, location, and the size of the organization. They oversee laboratory equipment, compliance, and operational workflows, often requiring a background in biomedical sciences or engineering.

What cities in Delaware are hiring for Biomedical Operations Manager jobs?

Cities in Delaware with the most Biomedical Operations Manager job openings:

Biomedical Operations Manager jobs near you
Infographic showing various Biomedical Operations Manager job openings in Delaware as of September 2026, with employment types broken down into 50% Full Time, and 50% Contract. Highlights an 100% In-person job distribution.

Product Quality Engineer 2

Newark, DE • On-site

Hologic
Health Care and Social Assistance • 5 - 10K employees
Learn more about Hologicexternal

$78K - $122K/yr

Full-time

Re-posted 21 days ago

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

Job description


Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. In this role, you'll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you'll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you're a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation.
Knowledge:
  • Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP.
  • Familiarity with root cause analysis tools, risk management principles, and compliance frameworks.
  • Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility.

Skills:
  • Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues.
  • Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations.
  • Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
  • Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained.
  • Proficiency in developing or improving testing methods for complaint investigations and technical activities.
  • Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements.
  • Preferred: Familiarity with verification and validation requirements and the development of testable and measurable specifications.

Behaviors:
  • Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements.
  • Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes.
  • Collaborative and team-oriented, building productive relationships across functions to drive quality improvements.
  • Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution.
  • Continuous improvement mindset, driving process optimization and identifying opportunities to enhance product quality.

Experience:
  • Bachelor's degree in Engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required.
  • 2-5 years of experience in quality engineering, product development, or R&D, preferably in an FDA-regulated industry.
  • Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
  • Familiarity with internal and external audits, including Notified Body and FDA inspections.

Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $78,000-$122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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