OPT Design Engineer Jobs
Design Engineer jobs on OPT require a STEM-designated degree in mechanical, electrical, or industrial engineering, which qualifies you for 24-month OPT extension. Most employers in this field file H-1B visa petitions for strong candidates, making it one of the more sponsorship-friendly paths for international engineers.
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Get Access To All JobsINTRODUCTION
Design Assurance Engineer 2 will provide design assurance support for new product development by ensuring that design controls, verification and validation, risk management, regulatory compliance, and product change activities are effectively implemented and maintained.
Responsibilities
- Provide design assurance support for new product development and on-market medical devices.
- Facilitate application of design controls throughout product development and sustaining product activities.
- Support manufacturing-related design changes, regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
- Participate in new product development projects by ensuring product inputs are clearly defined and that design verification and validation activities confirm requirements are met.
- Support test method validation as part of verification and validation activities.
- Participate in sustaining product projects by ensuring projects are well-defined, remain on task, and include required verification, validation, and risk management activities.
- Collaborate with R&D to coordinate design elements of Risk Management files and ensure compliance with applicable standards and internal policies.
- Coordinate Health Risk Assessment activities for on-market products, with manager or lead support as needed.
- Analyze product issues efficiently, including defining problems and evaluating potential impact.
- Assess product change requests for design impact and determine required supporting documentation for implementation.
KNOWLEDGE
- FDA Quality System Regulations, especially Design Control requirements.
- ISO 13485 and Medical Device Directive requirements.
- ISO 14971 Risk Management requirements.
- Verification and validation requirements for regulated products.
- Requirements analysis, including development of measurable and testable specifications.
- Familiarity with usability, reliability, electrical safety, software, sterilization, packaging, and biocompatibility standards.
- Preferred knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments.
SKILLS
- Ability to support design control activities in a regulated medical device environment.
- Ability to review and assess product and project documentation for compliance.
- Strong analytical skills for evaluating product issues, risks, and design change impacts.
- Ability to coordinate cross-functional activities related to risk management and health risk assessments.
- Effective project team participation and collaboration.
- Clear communication of compliance assessments and technical findings.
- Ability to define, review, and evaluate verification and validation requirements.
BEHAVIOR
- Collaborative and team-oriented, especially when working with R&D and project teams.
- Detail-oriented with a strong focus on compliance and documentation quality.
- Proactive in identifying design, regulatory, and risk-related concerns.
- Objective and analytical when evaluating product issues and change requests.
- Organized and able to keep projects focused and on task.
- Acting as a compliance advocate while maintaining effective communication with stakeholders.
Experience
Technical Bachelor’s Degree is required.
2+ years of experience preferred, ideally in the medical device industry.
Experience supporting regulated product development, sustaining engineering, or design assurance activities is preferred.
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.
INTRODUCTION
Design Assurance Engineer 2 will provide design assurance support for new product development by ensuring that design controls, verification and validation, risk management, regulatory compliance, and product change activities are effectively implemented and maintained.
Responsibilities
- Provide design assurance support for new product development and on-market medical devices.
- Facilitate application of design controls throughout product development and sustaining product activities.
- Support manufacturing-related design changes, regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
- Participate in new product development projects by ensuring product inputs are clearly defined and that design verification and validation activities confirm requirements are met.
- Support test method validation as part of verification and validation activities.
- Participate in sustaining product projects by ensuring projects are well-defined, remain on task, and include required verification, validation, and risk management activities.
- Collaborate with R&D to coordinate design elements of Risk Management files and ensure compliance with applicable standards and internal policies.
- Coordinate Health Risk Assessment activities for on-market products, with manager or lead support as needed.
- Analyze product issues efficiently, including defining problems and evaluating potential impact.
- Assess product change requests for design impact and determine required supporting documentation for implementation.
KNOWLEDGE
- FDA Quality System Regulations, especially Design Control requirements.
- ISO 13485 and Medical Device Directive requirements.
- ISO 14971 Risk Management requirements.
- Verification and validation requirements for regulated products.
- Requirements analysis, including development of measurable and testable specifications.
- Familiarity with usability, reliability, electrical safety, software, sterilization, packaging, and biocompatibility standards.
- Preferred knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments.
SKILLS
- Ability to support design control activities in a regulated medical device environment.
- Ability to review and assess product and project documentation for compliance.
- Strong analytical skills for evaluating product issues, risks, and design change impacts.
- Ability to coordinate cross-functional activities related to risk management and health risk assessments.
- Effective project team participation and collaboration.
- Clear communication of compliance assessments and technical findings.
- Ability to define, review, and evaluate verification and validation requirements.
BEHAVIOR
- Collaborative and team-oriented, especially when working with R&D and project teams.
- Detail-oriented with a strong focus on compliance and documentation quality.
- Proactive in identifying design, regulatory, and risk-related concerns.
- Objective and analytical when evaluating product issues and change requests.
- Organized and able to keep projects focused and on task.
- Acting as a compliance advocate while maintaining effective communication with stakeholders.
Experience
Technical Bachelor’s Degree is required.
2+ years of experience preferred, ideally in the medical device industry.
Experience supporting regulated product development, sustaining engineering, or design assurance activities is preferred.
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.
See all 1,932+ OPT Design Engineer Jobs
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Get Access To All JobsTips for Finding OPT Sponsorship as a Design Engineer
Target STEM-heavy industries first
Aerospace, automotive, semiconductor, and medical device companies hire Design Engineers at scale and have established visa sponsorship pipelines. These industries are more experienced with OPT timelines and H-1B visa transitions than general manufacturing or small firms.
Highlight CAD and simulation tools prominently
Proficiency in SolidWorks, CATIA, AutoCAD, or ANSYS signals job-readiness immediately. Employers sponsoring OPT students want candidates who contribute from day one, so tool-specific experience reduces their perceived risk of hiring someone on work authorization.
Apply well before your OPT start date
Design Engineer roles often involve security clearance checks, background screening, or hardware procurement approvals. Starting your search three to four months early gives employers enough lead time to process onboarding without rushing your authorization paperwork.
Ask directly about sponsorship during the offer stage
Frame the conversation around your STEM OPT extension: you have up to three years of authorized work time before H-1B sponsorship is required. Many hiring managers do not realize this, and clarifying it early removes the biggest objection to hiring international candidates.
Build a portfolio around real engineering deliverables
Capstone projects, internship work, or personal builds that show tolerancing decisions, material selection, or prototype iteration demonstrate engineering judgment. Employers sponsoring OPT students need confidence in technical output, and a portfolio provides that evidence faster than a resume alone.
Prioritize companies with H-1B filing history
Companies that have filed H-1B petitions for Design Engineers in the past are far more likely to sponsor again. This filing history is public record, and filtering for it before applying helps you spend time on employers who already understand the sponsorship process.
Design Engineer OPT: Frequently Asked Questions
Do Design Engineer jobs typically qualify for the 24-month STEM OPT extension?
Yes. Design Engineer roles almost always qualify for the STEM OPT extension because they require a degree in engineering, which appears on the DHS STEM designated degree list. To apply for the extension, your employer must be enrolled in E-Verify and you must file Form I-765 before your initial 12-month OPT expires.
How do I find Design Engineer employers who sponsor OPT students?
Migrate Mate filters job listings specifically for employers willing to sponsor F-1 OPT and H-1B candidates, so you are not applying to roles that will screen you out at the authorization question. Focusing your search there saves significant time compared to sorting through general job postings where sponsorship willingness is unclear.
Can I work as a Design Engineer during the 60-day grace period between jobs?
No. You cannot perform any work during the 60-day grace period following the end of your authorized OPT employment. You must have a new OPT job offer that falls within your authorized period, or transition to a new status. Working without authorization during the grace period creates serious immigration consequences.
Does a Design Engineer role at a startup or small company count for OPT purposes?
Yes, company size does not affect OPT work authorization eligibility. Any legitimate U.S. employer can hire you on OPT, including startups. The key requirements are that the work is directly related to your degree field and, for the STEM extension, the employer is enrolled in E-Verify. Smaller companies may be less familiar with the process, so be prepared to walk them through the E-Verify enrollment requirement.
What happens to my Design Engineer OPT authorization if my employer files an H-1B petition for me?
If your employer files an H-1B petition on your behalf before your OPT expires, and your status is still active on April 1, you may be eligible for cap-gap protection. This automatically extends your OPT authorization through September 30 of that year, allowing you to continue working as a Design Engineer without any gap in employment authorization while the petition is pending.