Medical Devices OPT Jobs in Delaware
Medical devices F-1 OPT sponsorship jobs in Delaware are concentrated around Wilmington and the broader New Castle County corridor, where companies like Siemens Healthineers and Teleflex have maintained a presence. Delaware's life sciences sector, supported by proximity to Philadelphia's research ecosystem, creates demand for engineering, regulatory affairs, and quality assurance roles that commonly align with OPT eligibility.
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Get Access To All JobsINTRODUCTION
Hologic is a global medical technology company focused on women’s health and wellbeing. Our Newark, Delaware team manufactures the 3Dimensions Mammography System, recognized as the “Coolest Thing Made in Delaware,” which helps detect breast cancer earlier and with greater certainty.
Join a high-growth, world-class manufacturing facility producing life-saving medical devices.
Job Summary:
Product Quality Engineer will make a direct impact on patient safety and product excellence by serving as a key quality partner for on-market medical devices. In this role, you will investigate product performance issues and customer complaints, conduct risk assessments and root cause analyses, and drive data-based solutions that enhance product quality and reliability. Collaborating across Engineering, Manufacturing, Regulatory, and Quality teams, you will lead cross-functional efforts to implement corrective and preventive actions, ensuring continuous improvement and compliance throughout the product lifecycle. This is an opportunity to influence meaningful change while helping deliver high-quality medical devices that improve patient outcomes.
Key Responsibilities
In addition to other duties as business needs require, the Product Quality Engineer will:
- Lead complaint investigations and root cause analyses, including prioritization based on product risk, data trends, and strategic impact, and coordination/communication with stakeholders.
- Perform data analysis and trending of complaints and failure modes; identify risk mitigations and prepare/present findings and recommendations to internal stakeholders and Leadership.
- Partner with cross-functional teams to perform Health Risk Assessments, determine need for CAPAs, recommend and scope changes, and implement design/process updates (drawings, fixtures/tooling, testing, and change control documentation).
- Develop and improve testing methods used for complaint investigations and root cause activities and provide technical support to the complaint intake and PMQA field investigation teams.
- Assess product changes for impact on design and risk management, define required supporting documentation, and provide post-market feedback to Operations, Engineering, and R&D to improve current and future products.
- Support quality system activities including product quality metrics reporting, internal and external audits (facility, supplier, Notified Body, FDA), and monthly Quality Investigation Review Boards while applying company policies and procedures.
Education
Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)
Experience
Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 0-2 years experience
- Experience in an FDA regulated industry preferred
- Experience in root cause analysis or product development/R&D is beneficial
Skills
- Familiarity with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP
- Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
- Ability to appropriately assess written product and project documentation as an advocate for compliance, and ability to effectively communicate assessment
- Knowledge of root cause analysis tools and ability to effectively participate in root cause activities for complaint investigations, NCs, CAPAs, etc.
- Good communication and presentation skills
Preferred Qualifications
- Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment
- Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
- Working knowledge of verification and validation requirements for a regulated product
- Familiarity with requirements analysis, including development of testable and measurable specifications
- Knowledge of risk based and statistical analysis concepts
Compensation
The annualized base salary range for this role is $55,000 - $86,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
INTRODUCTION
Hologic is a global medical technology company focused on women’s health and wellbeing. Our Newark, Delaware team manufactures the 3Dimensions Mammography System, recognized as the “Coolest Thing Made in Delaware,” which helps detect breast cancer earlier and with greater certainty.
Join a high-growth, world-class manufacturing facility producing life-saving medical devices.
Job Summary:
Product Quality Engineer will make a direct impact on patient safety and product excellence by serving as a key quality partner for on-market medical devices. In this role, you will investigate product performance issues and customer complaints, conduct risk assessments and root cause analyses, and drive data-based solutions that enhance product quality and reliability. Collaborating across Engineering, Manufacturing, Regulatory, and Quality teams, you will lead cross-functional efforts to implement corrective and preventive actions, ensuring continuous improvement and compliance throughout the product lifecycle. This is an opportunity to influence meaningful change while helping deliver high-quality medical devices that improve patient outcomes.
Key Responsibilities
In addition to other duties as business needs require, the Product Quality Engineer will:
- Lead complaint investigations and root cause analyses, including prioritization based on product risk, data trends, and strategic impact, and coordination/communication with stakeholders.
- Perform data analysis and trending of complaints and failure modes; identify risk mitigations and prepare/present findings and recommendations to internal stakeholders and Leadership.
- Partner with cross-functional teams to perform Health Risk Assessments, determine need for CAPAs, recommend and scope changes, and implement design/process updates (drawings, fixtures/tooling, testing, and change control documentation).
- Develop and improve testing methods used for complaint investigations and root cause activities and provide technical support to the complaint intake and PMQA field investigation teams.
- Assess product changes for impact on design and risk management, define required supporting documentation, and provide post-market feedback to Operations, Engineering, and R&D to improve current and future products.
- Support quality system activities including product quality metrics reporting, internal and external audits (facility, supplier, Notified Body, FDA), and monthly Quality Investigation Review Boards while applying company policies and procedures.
Education
Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)
Experience
Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 0-2 years experience
- Experience in an FDA regulated industry preferred
- Experience in root cause analysis or product development/R&D is beneficial
Skills
- Familiarity with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP
- Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
- Ability to appropriately assess written product and project documentation as an advocate for compliance, and ability to effectively communicate assessment
- Knowledge of root cause analysis tools and ability to effectively participate in root cause activities for complaint investigations, NCs, CAPAs, etc.
- Good communication and presentation skills
Preferred Qualifications
- Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment
- Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
- Working knowledge of verification and validation requirements for a regulated product
- Familiarity with requirements analysis, including development of testable and measurable specifications
- Knowledge of risk based and statistical analysis concepts
Compensation
The annualized base salary range for this role is $55,000 - $86,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
OPT Medical Devices Job Roles in Delaware
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Search Medical Devices Jobs in DelawareMedical Devices OPT Sponsorship Jobs in Delaware: Frequently Asked Questions
Which medical devices companies sponsor F-1 OPT visas in Delaware?
Delaware-based and regionally active medical devices employers that have historically hired international students on OPT include Siemens Healthineers, Teleflex, and Incyte, which operates at the intersection of biotech and medical applications. Larger contract manufacturers and distributors in the Wilmington area also participate in OPT hiring, particularly for engineering and quality roles. Sponsorship availability varies by role and business need, so confirming with each employer directly is important.
Which cities in Delaware have the most medical devices F-1 OPT sponsorship jobs?
Wilmington is Delaware's primary hub for medical devices OPT opportunities, given its concentration of life sciences and specialty manufacturing employers. Newark, home to the University of Delaware, also sees hiring activity, particularly for research and product development roles. The I-95 corridor connecting Wilmington to Philadelphia expands the accessible job market, with some employers listing Delaware addresses while operating across the tristate region.
What types of medical devices roles typically qualify for F-1 OPT sponsorship?
Roles in quality engineering, regulatory affairs, manufacturing process engineering, R&D, and clinical applications support are among those most commonly filled through OPT in the medical devices sector. These positions typically require a degree in biomedical engineering, mechanical engineering, or a related field, which aligns well with OPT eligibility requirements. Roles must be directly related to your field of study for OPT to apply, so degree-to-role alignment is essential.
How do I find medical devices F-1 OPT sponsorship jobs in Delaware?
Migrate Mate is built specifically for international students and filters jobs by visa type, including F-1 OPT, and by industry such as medical devices, making it straightforward to identify Delaware employers actively open to OPT candidates. Searching Migrate Mate's job board for Delaware medical devices roles saves time compared to manually screening general postings that rarely specify sponsorship willingness upfront.
Are there any state-specific or industry-specific considerations for F-1 OPT sponsorship in Delaware's medical devices sector?
Delaware's medical devices employers are subject to FDA regulatory oversight, which means many roles require familiarity with quality management systems such as ISO 13485 and 21 CFR Part 820. Candidates with coursework or project experience in these frameworks are more competitive. Delaware also has no state income tax on wages, which is a financial consideration worth noting. STEM OPT extension eligibility depends on whether your degree program appears on the official STEM Designated Degree Program list.