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Fda Openings Jobs (NOW HIRING)

Tempus

Senior Quality Engineer

Redwood City, CA · On-site +1

Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Ott Scientific

Quality Control Analyst I

Warrington, PA · On-site

$59K - $69K/yr

We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA's ChemStewards ® Management ... Experience with Open Lab, Chem Station and/or Empower analytical software preferred. * Proficiency ...

Integer

Senior Regulatory Affairs Specialist

Plymouth, MN · On-site

$113K - $165K/yr

... are open and honest with one another Integrity We do the right things and do things right The ... Ensures relevant International, ISO and FDA Export requirements are met, as required and ensures ...

Ironside Human Resources

Mammographer

Gallup, NM

Strong knowledge of breast anatomy, positioning techniques, and MQSA/FDA compliance standards with ... Surrounded by beautiful natural landscapes and wide-open spaces * Ideal setting for professionals ...

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What are the key skills and qualifications needed to thrive in FDA job openings, and why are they important?

To thrive in FDA job openings, candidates typically need a strong background in science, regulatory affairs, and analytical skills, often with a relevant degree in biology, chemistry, pharmacy, or related fields. Familiarity with regulatory databases, submission systems (such as eCTD), and certifications like RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, effective communication, and the ability to work collaboratively are essential soft skills for success. These competencies ensure regulatory compliance, thorough review of submissions, and effective teamwork in safeguarding public health.

What are some common challenges faced by professionals starting in FDA roles, and how can applicants prepare for them?

Professionals beginning their careers at the FDA often encounter challenges such as adapting to complex regulatory frameworks, working with cross-disciplinary teams, and managing the pace of policy changes. To prepare, applicants should familiarize themselves with FDA guidelines and regulatory processes, develop strong communication skills to collaborate effectively with scientists, regulators, and industry representatives, and stay updated on current public health issues. Proactive learning and seeking mentorship within the organization can also ease the transition and foster professional growth.

What are FDA openings?

FDA openings refer to job opportunities or vacancies at the U.S. Food and Drug Administration (FDA). The FDA is a federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other related products. These openings span a wide range of roles, including scientists, inspectors, analysts, administrative professionals, and more. Candidates can find current job listings and application instructions on the official USAJOBS website and the FDA’s careers page. Working at the FDA offers the chance to contribute to public health and safety at a national level.
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Fda Openings jobs near you
Infographic showing various Fda Openings job openings in the United States as of July 2026, with employment types broken down into 1% Locum Tenens, 79% Full Time, 17% Part Time, 2% Contract, and 1% Nights. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.
Senior Systems Engineer - Hybrid (2 Openings)

Senior Systems Engineer - Hybrid (2 Openings)

DivIHN Integration Inc

Plymouth, MN • On-site

$110K - $150K/yr

Contractor

Posted 27 days ago

Job description

For further inquiries regarding the following opportunity, please contact our Talent Specialist:
Abdul at 224 507 1295
Vinod at 224 507 1294

Title: Senior Systems Engineer - Hybrid (2 Openings)
Location: Plymouth, MN
Duration: 12 Months
 
Your Role
You will be responsible for supporting the overall technical direction and work for novel Acute Therapies products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. You will review and approve design concepts/changes and provide general direction to technical staff, including ensuring that quality is built into the design during new product development and/or sustaining activities. Proactively supervising the program and developing strategies to mitigate technical risks is expected as well as reporting on the progress to senior management during routine cadence meetings.
Essential Duties and Responsibilities
• Perform the activities associated with the Systems Engineering of one or more products in different stages of the product lifecycle from new product development to post-market surveillance
• Understand clinical and user needs and apply them to product realization
• Capture inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service, etc.
• Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a Systems perspective
• Initiate, develop, and lead feasibility by crafting design concepts and research methodologies that best meet both current and future customer / business needs for a product or process domain area
• Build and maintain Design History File elements and ensure traceability to requirements
• Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability
• Anticipate technical challenges and risk scenarios and then prepare, lead, and execute mitigation strategies to ensure safe and effective results
• Resolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, Pareto charts, etc.
• Propose and drive solutions to technical problems that are ambiguous and diverse in scope
• Perform impact assessments on the Requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigations, then propose recommended mitigations with the rationale
• Influence partners and multi-functional team members within the project
• Drive consistency to FDA, ISO and IEC design control procedures, regulations and standards
• Use various software tools and programs (e.g. DOORS) to complete the above responsibilities
• Teach and mentor others in life cycle management methodologies
Qualifications, Education and/or Experience
• A Bachelor's degree in Electrical, Mechanical, Biomedical, Controls, Systems, Software or other related technical/engineering field
• 3+ years of industry work experience
• Must possess sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering
• A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware
• Demonstrated strong analytical and problem-solving skills
• Success in working with multi-functional, global teams
• Excellent interpersonal/communication/influencing skills