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Senior Development Engineer

Role overview

Qualifications

  • Bachelor of Science in Engineering or related degree required, advanced degree preferred
  • Specific Medical design experience required
  • Minimum of 7 years in medical (orthopedics) product development or a related field with demonstrated industry knowledge
  • Experience with Design Controls and Risk Management preferred

Responsibilities

  • Travel up to 40% of the time
  • Manage projects from initial concept through to production, ensuring timely completion and adherence to project goals
  • Regularly interact with surgeon customers to discuss product improvements and new instrument ideas
  • Coordinate with cross-functional teams to ensure technical and creative alignment

Key facts

  • Remote from: Michigan (USA)
  • Full time
  • Senior (5-10 years)
  • Software Development Engineer
  • English

Hard skills

Other skills

  • Communication
  • Teamwork
  • Detail Oriented
  • Empathy

About the company

Genesis Innovation Group logo

Genesis Innovation Group

Medical Devices & Equipment

From Genesis to Execution > Medical Device Development Our team has more than a century of experience in the medical device development space, and over two hundred patents and innovations to our names combined. We collect inputs from the end-user and we engage the end-user. We identify the risks that threaten our ability to satisfy the needs of the end-user and then work systematically to mitigate those risks one after the next. > Medical Device Engineering Being able to pull from our customers, inventors, or surgeons the needed information to be able to turn that product idea into a reality, and into a concept that actually is workable is something we do every day. > FDA Project Planning A lot of the medical device engineering that’s valuable is the project planning. With the FDA, there are so many requirements. Fortunately, this is an area where we have a great deal of experience. > Medical Device Intellectual Property Creating valuable Intellectual Property is one of the major things that we do. Getting a patent is actually a relatively easy thing to do. Getting a good patent is difficult to do! > Medical Device Commercialization The benefit that we have to offer at Genesis is the fact that we have over 33 years of medical device commercialization experience, which has created a phenomenal network of existing relationships in the field. We have a great deal of experience working with direct reps, agencies, and independent distributors. Additionally, we have often worked alongside and with large and small medical device companies. > Medical Device Finance and Operations The Genesis Finance Operation Services brings Advisors, Legal, Insurance, and Accounting capabilities to the table for the start-up medical device companies we work with. This approach helps the entrepreneurs we work with a focus on what they do best while ensuring that the organization and business are structured correctly from the very beginning.

Company details

IndustryMedical Devices & Equipment
Company size11 - 50

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Job description

We are looking to hire an experienced Senior Development Engineer II. As the Senior Development Engineer II, you will be responsible for designing, developing, and testing medical and surgical components, equipment, and instruments.  This role involves leading projects from initial design conception through to production, ensuring that all products meet technical and regulatory standards.

Genesis Innovation Group (GIG) is a unique Venture Capital and Business Development firm concentrated on medical devices.  Our role as investors and industry partners is to focus on the creative power of entrepreneurs by leveraging our network, resources, and experience to ensure their success. Combined, we have more than a century of experience in the medical device space, and over two hundred patents and innovations to our names.

In this role you will:

  • Travel up to 40% of the time
  • Manage projects from initial concept through to production, ensuring timely completion and adherence to project goals
  • Regularly interact with surgeon customers to discuss product improvements and new instrument ideas
  • Coordinate with cross-functional teams to ensure technical and creative alignment
  • Create project plan including assigning tasks to team members
  • Monitor and review work of team members to ensure high quality work
  • Manage project budgets, ensuring effective allocation of financial resources
  • Monitor expenditures and adjust as necessary
  • Own the regulatory clearance planning and strategy pathway to be approved by the team lead
  • Maintain documentation for regulatory submissions and quality management systems
  • Lead the design and development of medical and surgical components, equipment, and instruments
  • Understand and make well-reasoned design decisions and tradeoffs in their area
  • Create and modify detailed CAD models and technical drawings
  • Deliver complex products to test labs
  • Conduct tests to evaluate product performance, safety, and functionality
  • Troubleshoot and resolve any issues that arise during the testing phase
  • Evaluate negative or questionable test results and advises team on impact and solutions
  • Build and maintain strong relationships with surgeons, clients, and suppliers
  • Actively seek and incorporate feedback from stakeholders into the design and development process
  • Participate in continuous improvement initiatives to enhance product quality and development processes
  • Provide technical advice and weighs in on technical decisions that impact other teams or the company at large

To keep up with our fast-paced, detail-driven business qualified candidates will have:

  • Bachelor of Science in Engineering or related degree required, advanced degree preferred
  • Specific Medical design experience required
  • Minimum of 7 years in medical (orthopedics) product development or a related field with demonstrated industry knowledge
  • Experience with Design Controls and Risk Management preferred
  • Ability to empathize with the user (i.e., surgeons, scrub techs, sales reps) of the implants/instruments they are producing and use that empathy to guide decision-making
  • Ability to work individually and on a team
  • Ability to produce well-written post-training reports and provide written metrics and feedback
  • High attention to detail
  • Travel up to 40%

Why Join Genesis Innovation Group:

If you are looking to further your career in a pioneering and evolving industry, consider joining our team of professionals.  We value and appreciate our employees and will support you with great company culture and opportunities for professional growth.  At Genesis Innovation Group, we provide competitive wages, a bonus program, benefits, and strong team collaboration. Apply today for immediate and confidential consideration to become our next Senior Development Engineer II.  To learn more about us, visit us online at www.genesisinnovationgroup.com.  

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Marcus Rivera

Chief Revenue Officer

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