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Research And Development Engineer Medical Device Jobs in Edison, NJ

Siri InfoSolutions Inc

R&D Engineer

Raritan, NJ · On-site

... Medical Device Regulatory Standards, MDD and MDR · Knowledge of statistical analysis and design of experiments (DOE) preferred · Knowledge of Computer programs. · Excellent Interpersonal ...

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Research And Development Engineer Medical Device information

See Edison, NJ salary details

$20.7K

$100K

$156.3K

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

As of Aug 20, 2026, the average yearly pay for research and development engineer medical device in Edison, NJ is $99,975.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,200.00 and $121,100.00 per year, depending on experience, location, and employer.

What does a research and development engineer do in the medical device industry?

A Research and Development (R&D) Engineer in the medical device industry is responsible for designing, developing, and testing new medical devices and technologies. They work closely with cross-functional teams to ensure products meet regulatory standards, are safe for patient use, and address clinical needs. Their tasks may include prototyping, conducting experiments, analyzing data, and collaborating with manufacturing teams to bring products from concept to market. R&D Engineers also stay updated on technological advancements and regulatory changes to ensure innovation and compliance.

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

To excel as a Research and Development Engineer in Medical Devices, you need a solid background in biomedical engineering or a related field, strong problem-solving skills, and experience with product development cycles. Familiarity with CAD software, prototyping tools, regulatory standards like ISO 13485, and relevant certifications (such as Six Sigma) is highly valued. Excellent teamwork, creativity, and effective communication are crucial soft skills for collaborating across multidisciplinary teams and driving innovation. These competencies ensure the design and launch of safe, effective, and compliant medical devices that improve patient outcomes.

What are some common challenges faced by research and development engineers in the medical device industry?

Research and Development Engineers in the medical device industry often face challenges such as navigating complex regulatory requirements, managing tight project timelines while ensuring product safety and efficacy, and collaborating with cross-functional teams like quality assurance and clinical affairs. Additionally, adapting to rapid technological advancements and integrating feedback from clinicians and end-users into the design process can be demanding. These challenges require strong problem-solving skills, adaptability, and effective communication to deliver innovative and compliant medical devices.

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

AspectResearch And Development Engineer Medical DeviceQuality Assurance Engineer Medical Device
Primary FocusDesigning, developing, and testing new medical device productsEnsuring products meet quality standards and regulatory requirements
Required CredentialsEngineering degree, knowledge of product developmentEngineering or science degree, knowledge of quality systems
Work EnvironmentResearch labs, product development teamsManufacturing facilities, quality control departments
Industry UsageInvolved in innovation and product creationInvolved in compliance, validation, and process improvement

While both roles require engineering knowledge and are integral to the medical device industry, Research And Development Engineers focus on creating and testing new products, whereas Quality Assurance Engineers ensure these products meet safety and quality standards throughout production.

What are popular job titles related to Research And Development Engineer Medical Device jobs in Edison, NJ?

For Research And Development Engineer Medical Device jobs in Edison, NJ, the most frequently searched job titles are:

What job categories do people searching Research And Development Engineer Medical Device jobs in Edison, NJ look for?

The top searched job categories for Research And Development Engineer Medical Device jobs in Edison, NJ are:

What cities near Edison, NJ are hiring for Research And Development Engineer Medical Device jobs?

Cities near Edison, NJ with the most Research And Development Engineer Medical Device job openings:

Research And Development Engineer Medical Device jobs near you
Infographic showing various Research And Development Engineer Medical Device job openings in Edison, NJ as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 16% Part Time, 1% Temporary, and 5% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution, with an average salary of $99,975 per year, or $48.1 per hour.

Senior Medical Device Research and Development Engineer

Cresilon, Inc.

Brooklyn, NY • On-site

$109K - $150K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 14 days ago

Job description

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.
Description:
The Senior Medical Device R&D Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation, including prototype design and fabrication, and data generation through designed experiments.
The Senior Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what's necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness.
Role level is contingent on experience, but this is not an entry-level role. This is a full-time, on-site position, located in Brooklyn, New York.
Responsibilities
  • Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use.
  • Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety.
  • Lead cross-functional teams to develop new products, address design issues, and maintain existing designs.
  • Apply strong problem-solving skills to find solutions to complex problems.
  • Work independently to plan and schedule own activities necessary to meet project timelines.
  • Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
  • Lead the creation of design history file documentation through the new product development process.
  • Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications.
  • Generate technical protocols/reports to support device safety and efficacy.
  • Invent/create concepts and designs and submit invention disclosures.
  • Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses.
  • Author protocols and reports including development studies and design verification/validation activities.
  • Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes.
  • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures.
  • Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs.
  • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication.
  • Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines.
  • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,
  • Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data
  • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company.
  • Manage part-time staff as a research leader and mentor for ongoing research projects.
  • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization.
  • Provide other project or product support as needed in order to support Cresilon's business objective.
  • Responsibilities may include other duties as assigned and as required.

Requirements
Required Qualifications
  • BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline.
  • A minimum of 5+ years of product development experience is required.
  • A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred)
  • Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment.
  • Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans.
  • Experience leading complex product development initiatives from concept through product launch/release.
  • Good working knowledge of anatomy and surgical procedures is required.
  • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively.
  • Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies.
  • Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks
  • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner.
  • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills.
  • Requires strong leadership skills, excellent written and verbal communication and presentation skills.
  • Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007.
  • Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP)
  • Good understanding of statistical tools and validation/verification techniques.
  • Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required.
  • Legal authorization to work in the United States is required.

Preferred Qualifications
  • An advanced degree (MS or Ph.D.) is strongly preferred.
  • Hands-on experience in product development with Class II and Class III medical devices.
  • Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs.
  • Experience with IDE and PMA submissions.
  • Six-Sigma green belt or black belt certification

Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.
Benefits
  • Competitive annual base salary range of $100,000 - $160,000, depending upon job level and qualifications
  • Paid Vacation, Sick, & Holidays
  • Monthly MetroCard Reimbursement
  • 401(k) & Roth Retirement Savings Plan with company match up to 5%
  • Work/Life Employee Assistance Program
  • Company Paid Life and Short-Term Disability Coverage
  • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

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