Wilmington, DE · On-site
$40 - $50/hr
... Engineering teams · Manage multiple CAPAs in a fast-paced environment Required Qualifications: · Bachelor's degree in Mechanical, Biomedical, Quality Engineering, or related field · Hands-on ...
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Wilmington, DE · On-site
$40 - $50/hr
... Engineering teams · Manage multiple CAPAs in a fast-paced environment Required Qualifications: · Bachelor's degree in Mechanical, Biomedical, Quality Engineering, or related field · Hands-on ...
$41K - $50K
6% of jobs
$50K - $59.1K
12% of jobs
$59.1K - $68.1K
5% of jobs
$72.6K is the 25th percentile. Wages below this are outliers.
$68.1K - $77.1K
3% of jobs
$77.1K - $86.1K
13% of jobs
$86.1K - $95.1K
7% of jobs
The median wage is $96.6K / yr.
$95.1K - $104.1K
19% of jobs
$111.7K is the 75th percentile. Wages above this are outliers.
$104.1K - $113.1K
11% of jobs
$113.1K - $122.1K
12% of jobs
$122.1K - $131.1K
4% of jobs
$131.1K - $140.1K
7% of jobs
$41K
$94.9K
$140.1K
A Biomedical Engineer Manager oversees the design, development, and maintenance of medical equipment and healthcare technology. They lead teams of biomedical engineers, ensuring compliance with industry regulations and safety standards. Their responsibilities include project management, budgeting, vendor coordination, and collaboration with healthcare professionals to improve medical device performance. Additionally, they may conduct research to innovate new technologies and optimize existing systems. Effective communication and leadership skills are essential for managing both technical and organizational aspects of the role.
A Biomedical Engineer Manager’s day often involves overseeing engineering teams, guiding medical device development projects, and ensuring product compliance with healthcare regulations. They regularly coordinate with cross-functional groups, including research scientists, clinicians, and regulatory specialists, to align project objectives and timelines. Managers also allocate resources, address technical and personnel challenges, and provide mentoring to junior engineers. This role requires balancing hands-on technical work with strategic planning to deliver safe, effective medical solutions on time and within budget.
To thrive as a Biomedical Engineer Manager, you need a strong background in biomedical engineering, project management experience, and often a relevant bachelor's or master's degree. Familiarity with regulatory compliance systems (such as FDA standards), medical device development tools, and quality assurance certifications like PMP or Six Sigma is highly valued. Outstanding interpersonal communication, leadership, and problem-solving skills help distinguish top performers in this role. These skills ensure successful project delivery, regulatory compliance, and effective team leadership in a complex, multidisciplinary environment.
Wilmington, DE • On-site
$40 - $50/hr
Contractor
Posted 29 days ago
The CAPA Execution Specialist is responsible for executing corrective and preventive actions within a medical device manufacturing environment. This role focuses on hands-on investigation, root cause analysis, and implementation of corrective actions on the manufacturing floor, ensuring compliance with FDA and ISO standards.
Responsibilities:· Execute CAPAs end-to-end from investigation through closure
· Perform root cause analysis using tools such as 5 Whys and Fishbone
· Implement corrective and preventive actions on the manufacturing floor
· Work closely with assembly teams to ensure adherence to procedures
· Update SOPs, work instructions, and quality documentation
· Support document control activities including procedural updates
· Verify effectiveness of CAPAs and ensure sustainable solutions
· Collaborate with Quality, Manufacturing, and Engineering teams
· Manage multiple CAPAs in a fast-paced environment
· Bachelor’s degree in Mechanical, Biomedical, Quality Engineering, or related field
· Hands-on experience executing CAPAs in medical device manufacturing
· Strong knowledge of root cause analysis methodologies
· Experience working on the manufacturing floor
· Knowledge of FDA regulations and ISO standards
· Experience with document control systems
· Experience with electromechanical assembly or capital equipment manufacturing
· Familiarity with Agile or hybrid document control systems
· Experience handling both manufacturing and system-level CAPAs
The hourly rate for this position is US$40– $50 per hour.
Benefits:This is a contract position and does not include employer-provided benefits.
Equal Opportunity Employer:We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:Background checks may be conducted in accordance with applicable laws.
Work Authorization:Applicants must be authorized to work in the United States.
If interested in this opportunity! Please send your resume to ahmed@intellectt.com or give me a call at +1-732-653-9472
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51 - 200 Employees
Iselin, NJ, US
2018