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Medical Device Product Development Engineer Jobs in Delaware

Hologic

Systems Engineer

Newark, DE · On-site

$78K - $122K/yr

Support concept development, specification, and design of new medical imaging products. * Implement ... Knowledge of medical device regulations and standards, including: FDA QSR, ISO 13485, ISO 14971 ...

HK Recruiting

SR Electrical Engineer, R&D, NPD

Newark, DE

$105K - $136K/yr

Experience in an FDA regulated medical device industry is beneficial. Skills * Advanced knowledge ... Knowledge and experience working through full product lifecycle. * Proficiency with laboratory test ...

Hologic Inc.

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

... D to improve design and manufacture of devices in the field and in development. * Developing ... 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP * Ability to ...

Hologic

Product Quality Engineer 2

Newark, DE · On-site

$78K - $122K/yr

... D to improve design and manufacture of devices in the field and in development. * Developing ... 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP * Ability to ...

Hologic, Inc.

Product Quality Engineer 1

Newark, DE · On-site

$54.90 - $86/hr

Experience in root cause analysis or product development/R&D is beneficial Skills * Familiarity ... 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP. * Ability to ...

Hologic

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

... D to improve design and manufacture of devices in the field and in development. * Developing ... 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP * Ability to ...

Hologic Inc.

Product Quality Engineer 1

Newark, DE · On-site

$54K - $86K/yr

... D to improve design and manufacture of devices in the field and in development. * Developing ... 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP * Ability to ...

Fusion Life Sciences

System Engineers

Newark, DE · On-site

The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong ... product development lifecycle. Key Responsibilities: * Design Controls: Lead efforts to develop and ...

Brunswick

As part of the talented Product Development & Engineering team, you will be responsible for ... including medical, dental, vision, paid vacation, 401k (up to 4% match), Health Savings Account ...

Lund Boats

As part of the talented Product Development & Engineering team, you will be responsible for ... including medical, dental, vision, paid vacation, 401k (up to 4% match), Health Savings Account ...

AstraZeneca

Director, AI Product Development

Wilmington, DE · On-site

$226K - $236K/yr

Partner with Marketing, Medical Affairs,GIBEX, Field Operations, and IT to align product ... Partner with technicaldeliveryleads, engineering, and data science teams to translate requirements ...

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Showing results 21-40

All JobsMedical Device Product Development Engineer JobsMedical Device Product Development Engineer Jobs in Delaware

Medical Device Product Development Engineer information

See Delaware salary details

$39.5K

$88K

$132.6K

How much do medical device product development engineer jobs pay per year?

As of Sep 4, 2026, the average yearly pay for medical device product development engineer in Delaware is $87,960.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,100.00 and $100,100.00 per year, depending on experience, location, and employer.

What does a medical device product development engineer do?

A Medical Device Product Development Engineer is responsible for designing, developing, and testing medical devices to ensure they are safe, effective, and compliant with regulatory standards. They work closely with cross-functional teams, including quality assurance, regulatory affairs, and manufacturing, to take products from concept through to production. Their tasks often include prototyping, risk assessment, documentation, and troubleshooting any issues that arise during the development process. Additionally, they must stay updated on industry standards and regulations to ensure that products meet all necessary requirements for market approval.

What are the key skills and qualifications needed to thrive as a medical device product development engineer?

To thrive as a Medical Device Product Development Engineer, you need a strong background in biomedical, mechanical, or electrical engineering, along with knowledge of FDA regulations and product development processes. Familiarity with CAD software, prototyping tools, risk management systems, and regulatory standards such as ISO 13485 is typically required. Creativity, problem-solving, and effective teamwork are essential soft skills that drive innovation and ensure project success. These skills and qualifications are crucial for developing safe, effective medical devices that meet strict regulatory requirements and address real-world healthcare needs.

What are some common challenges medical device product development engineers face when working on new product designs?

Medical Device Product Development Engineers often navigate strict regulatory requirements and rigorous testing protocols to ensure product safety and compliance. Balancing innovative design with manufacturability and cost constraints can be challenging, as can coordinating input from cross-functional teams such as clinical, regulatory, and manufacturing. Additionally, managing project timelines while accommodating iterative design changes based on feedback or testing results requires strong organizational and communication skills.

What is the difference between Medical Device Product Development Engineer vs Quality Assurance Engineer?

AspectMedical Device Product Development EngineerQuality Assurance Engineer
CredentialsEngineering degree, certifications like PMP or Six Sigma often preferredEngineering or science degree, certifications like CQE or ISO auditor training
Work EnvironmentDesign labs, R&D departments, cross-functional teamsManufacturing facilities, quality control labs, compliance departments
Industry UsageInvolved in designing and developing new medical devicesEnsures products meet quality standards and regulatory requirements

While both roles are essential in the medical device industry, the Medical Device Product Development Engineer focuses on creating and improving devices, whereas the Quality Assurance Engineer ensures these devices meet safety and quality standards. Understanding these differences helps in choosing the right career path or job search focus.

What are popular job titles related to Medical Device Product Development Engineer jobs in Delaware?

For Medical Device Product Development Engineer jobs in Delaware, the most frequently searched job titles are:

What job categories do people searching Medical Device Product Development Engineer jobs in Delaware look for?

The top searched job categories for Medical Device Product Development Engineer jobs in Delaware are:

Medical Device Product Development Engineer jobs near you
Infographic showing various Medical Device Product Development Engineer job openings in Delaware as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 16% Part Time, and 5% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $87,960 per year, or $42.3 per hour.

Systems Engineer

Hologic

Newark, DE • On-site

$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

180th of 496 rated machine equipment manufacturers

Job description


Hologic is seeking a Systems Engineer to join our Research and Development team in Newark, Delaware. In this role, you will contribute to the development of advanced medical imaging systems and electromechanical subsystems that help improve clinical outcomes. This position requires regular onsite presence in Newark, DE to collaborate closely with cross-functional engineering teams and support hands-on system integration, testing, and troubleshooting.
You will work alongside electrical, mechanical, and software engineers, scientists, and product owners to support the design, integration, verification, and validation of medical imaging technologies.
Key Responsibilities
  • Contribute to the specification, design, component selection, system integration, verification, and validation of medical imaging systems and electromechanical subsystems.
  • Develop an in-depth understanding of system architecture design and clinical use of medical imaging systems.
  • Propose system definitions and specifications to meet customer requirements and user needs.
  • Support concept development, specification, and design of new medical imaging products.
  • Implement new electromechanical designs and modifications within defined cost, schedule, and performance targets.
  • Maintain traceability between system requirements and subsystem requirements.
  • Maintain traceability between product requirements, identified risks, and mitigation strategies.
  • Perform hands-on troubleshooting at system and subsystem levels.
  • Support engineering teams and system quality assurance through concept, implementation, and verification phases.
  • Collaborate with design engineers to define test methods and conditions.
  • Complete design documentation and Engineering Change Orders in accordance with Hologic procedures and best practices.
  • Create project schedules, track progress, and report status or issues to management and project teams.
  • Support design transfer to manufacturing.
  • Establish collaborative relationships with stakeholders across the division.
  • Manage multiple projects concurrently under supervision.
  • Continue to build technical expertise and professional development, contributing to innovative problem-solving and product development.

Qualifications
Education
  • Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, or a related technical discipline.

Experience
Preferred minimum:
  • 1-2 years of experience with a technical bachelor's degree, or
  • 0-2 years with a master's degree.

Skills and Knowledge
  • Understanding of systems engineering methodologies.
  • Experience with electromechanical design and embedded software development, ideally within the medical device field.
  • Experience with systems integration across electrical, mechanical, and software components.
  • Knowledge across multiple engineering disciplines.
  • Strong critical thinking, analytical, and problem-solving skills.
  • Familiarity with physical and mathematical modeling tools.
  • Knowledge of medical device regulations and standards, including: FDA QSR, ISO 13485, ISO 14971, IEC 60601-1 and IEC 60601-1-2, IEC 62304 (software lifecycle for medical devices)
  • Experience with Product Lifecycle Management (PLM) systems.
  • Strong communication, teamwork, and collaboration skills.
  • Experience with technical documentation and presentations.
  • Project management skills.
  • SolidWorks experience is a plus

So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
The annualized base salary range for this role $78,000 - $122,100 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.
As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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