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Research And Development Engineer Medical Device Jobs in Florida

Axogen

Sr. Engineer, R&D (Biomaterials)

Tampa, FL · On-site

$98K - $135K/yr

Job Summary of the Sr. Engineer, R&D The Sr. Engineer, Research & Development, is an experienced ... Minimum of 5 years of experience in the medical device or pharmaceutical industry. Product ...

Axogen

Sr. Engineer, R&D (Biomaterials)

Tampa, FL

$98K - $135K/yr

Job Summary of the Sr. Engineer, R&D The Sr. Engineer, Research & Development, is an experienced ... Minimum of 5 years of experience in the medical device or pharmaceutical industry. Product ...

Axogen

Sr. Engineer, R&D (Biomaterials)

Tampa, FL

$98K - $135K/yr

Job Summary of the Sr. Engineer, R&D The Sr. Engineer, Research & Development, is an experienced ... Minimum of 5 years of experience in the medical device or pharmaceutical industry. Product ...

AxoGen

Sr. Engineer, R&D

Tampa, FL · On-site

$98K - $135K/yr

Job Summary of the Sr. Engineer, R&D The Sr. Engineer, Research & Development, is an experienced ... Minimum of 5 years of experience in the medical device or pharmaceutical industry. Product ...

Medical Device Manufacturing Co

Be Seen First

Product Development Manager - Medical Device

Pompano Beach, FL · On-site

$107K - $134K/yr

Departmental Manager providing direct management of engineers, supervisors, and technicians ... the medical device industry. * 3+ years in a leadership role within product development ...

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Research And Development Engineer Medical Device information

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 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 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 are the key skills and qualifications needed to thrive as a Research and Development Engineer in Medical Devices, and why are they important?

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.
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What job categories do people searching Research And Development Engineer Medical Device jobs in Florida look for? The top searched job categories for Research And Development Engineer Medical Device jobs in Florida are:
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Research And Development Engineer Medical Device jobs near you

Sr. Research & Development Engineer, Device

Syncromune

Fort Lauderdale, FL • On-site

$84K - $114K/yr

Full-time

Re-posted 11 days ago

Job description

The Senior Research & Development (R&D) Engineer plays a pivotal role in designing, developing, and testing new and innovative medical devices, ensuring adherence to the company's Quality System. This multifaceted role involves collaboration with cross-functional teams to drive product development from concept to validation, all while maintaining rigorous quality, regulatory, and manufacturing standards.
Note: This is an onsite role in Ft. Lauderdale, FL. Some relocation assistance is available for this role as needed.
Responsibilities:
The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.
  • Design and develop medical devices made from metal and/or polymer. Work with vendors to develop effective and robust products and packaging solutions.
  • Lead the product development process from concept through Process Validation, ensuring alignment with performance specifications, quality standards, and regulatory and manufacturing requirements.
  • Assemble devices and sub-assemblies for R&D using standard manufacturing practices such as, adhesive bonding, heat bonding/fusing, cutting/trimming, cleaning, packaging, and tools such as UV cure equipment
  • Be able to work in a Controlled Environment Room (CER) following standard industry practices. Interface with assemblers to train and guide in assembly of devices for verification/validation.
  • Design and fabricate testing models and/or fixtures as needed.
  • Perform functional tests of devices and sub-assemblies, work with QA to develop standard test methods.
  • Perform functional testing, such as (but not limited to) strength of bond joints and flow analysis using equipment such as Instron tensile testers, pressure transducers and data acquisition software (i.e Labview).
  • Author technical documents such as test protocols/reports, lab notebook studies, and documents supporting regulatory submissions (i.e. IND, PMA, CE Mark).
  • Work with vendors to assist in developing manufacturing work instructions, as necessary.
  • Utilize statistical methods as required for the planning of required sample sizes necessary in testing. Analyze test results, culminating in comprehensive test reports. Draw conclusions/recommendations from the results.
  • Utilize SolidWorks to develop detailed 3-D CAD models and drawings of medical devices, and/or packaging. Includes components, subassembly, and top-level drawings.
  • Support pre-clinical studies such as animal studies or training studies.
  • Inspect incoming parts and components, in-process assemblies using standard tools such as calipers, pin gauges, snap gauges, smart scope systems, microscopes
  • Collaborate with internal and/or external resources (suppliers) to produce prototype device components.
  • Ensure that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.
  • Manufacture devices following simple to complex manufacturing process instructions and work instructions and maintaining Good Documentation Practices (GDP)
  • Abide by company quality system requirements, such as training to and following quality and procedure documents
  • Contribute to the company's overall Risk Management efforts including potential contribution to formal ISO 14971 Risk Management requirements, varied design, process, and use FMEAs, including but not limited to consideration of risk in Change Control, validations and verifications, CAPA, complaints, non-conforming materials, Design Controls, as well other Quality System elements (Process Control, Tooling and Equipment, Calibration, Supplier Controls, etc.) as needed.

Requirements:
BS in Engineering with 5+ years of medical device design and testing experience as well as:
  • Experience working in a clean room environment
  • Experience performing R&D work within a Design Control environment
  • Experience with combination products a plus
  • Experience with energy delivery systems (e.g., cryoablation) a plus
  • Basic computer skills in MS Office, SolidWorks and solid modeling
  • Ability to work in a fast-paced environment
  • Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed
  • Demonstrated ability to successfully work within a cross-functional team
  • Ability to organize work and prioritize tasks
  • Excellent verbal and writing skills
  • Possess a self-directing, self-starting work ethic
  • Machining skills not necessary, but a plus

Working Conditions: The work environment shall be at the Company headquarters in Fort Lauderdale, FL.
  • Domestic and International travel up to 40%
  • Ability to live up to 50 pounds
  • Regularly required to stand, sit, talk, hear, and use hands
  • Prolonged periods of sitting and standing

Syncromune is an Equal Opportunity Employer.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range: $135,000-$155,000
This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company's benefit plans.

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