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Research And Development Engineer Medical Device Jobs in Colorado

... research / development / engineering. 3) PMP certification. Desired Skills: 1) FDA or other regulatory environment. 2) Medical device projects. 3) Six Sigma or LEAN certifications. Additional ...

... medical device products - three to four projects at one time. This will involve gathering ... related to product research / development / engineering. 3) PMP certification. Additional ...

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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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Product Development Engineer I

Product Development Engineer I

Paragon 28, Inc.

Englewood, CO โ€ข Hybrid

$80K - $105K/yr

Other

Posted 3 days ago


Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.


What You Can Expect

Passionate about innovation in foot and ankle orthopedics? Paragon 28, a Zimmer Biomet company, is hiring an experienced Product Development Engineer I (E2) to support our fast-moving R&D team. The Product Development Engineer I has at least 2 years of professional experience and is responsible for leading various aspects of design and development as part of a project team with direct supervision. This position participates on meaningful projects that focus on design and development of medical devices with increasing levels of autonomy. This position is a hybrid role based our of our Englewood, Colorado location.

How You'll Create Impact
  • Produce deliverables in support product development efforts from ideation to commercialization through entire product life cycle and on a given timeline, as directed by senior engineering staff, including:
    • Research and evaluate competitive product for performance characteristics
    • Conceptualization of new design ideas with some understanding of the inadequacy of existing designs
    • Parametric modeling and detail design of P28 implant and instrument development
    • Work within the P28 product development procedure to create design control documentation for P28 design history files and technical files.
    • Participate in development of testing protocols and assist in the testing process for new and existing products
    • Compile and comprehend test results and implement/recommend appropriate design changes
    • Participate in activities related to project phase gate design reviews
    • Interface with 3rd party suppliers, contractors, testing houses, etc.
  • Assist the P28 Quality and Supply Chain departments to evaluate new suppliers for inclusion in the P28 approved supplier list
  • Assist P28 quality team in developing inspection plans
  • Observe surgery (live, cadaver, or video) on lower extremity pathology and formulate physician comments/ideas into meaningful design solutions. Document all notes.
  • Work to become technical expert resource within specific product categories for sales support and other departments via phone and live product training.
  • Assist on patent application preparation
  • Assist with other development projects as additional resource when needed, while balancing own workload
  • Other duties as directed by manager
Your Background
  • Requires a bachelor's degree in Mechanical Engineering, Biomedical Engineering or related engineering discipline with 2-4 years of experience.
  • Prior experience in medical device development helpful.
  • Experience in taking medical device or similar product from ideation to commercialization helpful.
  • Understanding of medical device industry regulatory requirements preferred.
  • Experience with CAD. SolidWorks preferred.
  • High proficiency in MS Office
  • Effective communication and presentation skills with ability to convey information and respond to questions from groups of peers
  • Ability to work in a team environment
Travel Expectations

Up to 10% of overnight travel.

Compensation Data

Salary Range: $80,000 - $105,000 USD annually depending on skills and experience


EOE

Employment Type: OTHER